Six Million More Nurses Needed Ensure Health for All by 2030, Says New WHO Report 07/04/2020 Grace Ren Nurses are on the frontline of the COVID-19 response in Thailand, where public sector nurses have been fighting for pay raises. The world needs 6 million more nurses in the next 15 years in order to reach the Sustainable Development Goals, according to the first-ever State of the World’s Nursing report released by the World Health Organization, Nursing Now, and the International Council of Nurses. The report, released Tuesday on World Health Day, explores challenges and successes faced by the world’s largest cadre of health workers, whose essential roles have been highlighted even more dramatically during the COVID-19 pandemic. “Nurses are the backbone of any health system. Today, many nurses find themselves on the frontline in the battle against COVID-19,” said WHO Director General Dr Tedros Adhanom Ghebreyesus, in a press release. ‘This report is a stark reminder of the unique role they play, and a wakeup call to ensure they get the support they need to keep the world healthy.’ “[The report] shows very clearly that we do not have enough nurses to meet the challenge of the SDG of Health for All by 2030 and that we will need to raise the number of qualified nurses by at least 6 million by 2030 to achieve that aim,” said Mary Watkins, co-chair of Nursing Now. There are just under 28 million certified nurses working around the world today. However, the distribution of nurses is highly unequal – approximately 80% of nurses serve only 50% of the world’s population. The greatest shortages of nurses are in Africa, South East Asia and the WHO Eastern Mediterranean region as well as some parts of Latin America. But governments all over must increase investment in nursing education, protections and pay for nurses – even high-income countries. “Individually, professionally, morally of course we all value nurses – but not economically,” said Howard Catton, chief executive officer of the International Council of Nurses. Shortages of nurses in poorer countries are exacerbated by “an over-reliance in high-income countries on migration” to supply nursing staff. “Wealthier countries are not producing enough nurses and are hiring them from ‘less fortunate’ countries at higher wages than can be achieved in their home countries,” added Watkins. The largest shortages of nurses are seen in some parts of Latin America, Africa, and Southeast Asia. Globally, nurses make up nearly 60% of the health workforce, but only 25% of the education budget is spent on them. Nurses’ pay is highly affected by austerity measures – just as one example, nurses in Zimbabwe are only paid US $60 per month despite rampant inflation raising the cost of living. In light of the global shortage of personal protective equipment during the COVID-19 emergency, governments must also work on improving nurses’ working conditions, according to the report. “There is a real need to see that employment terms are attractive for nurses, not only in terms of remuneration but also safety, both in terms of violence and sufficient personal protection equipment,” said Watkins. Additionally, nursing is a “female-dominated profession” with “a history of discrimination and inequality, pay and gender biases,” added Catton. The report noted that over 90% of the world’s nurses are women, but most leadership roles in nursing are held by men. “Our nurses are the bedrock of preparedness and strong health systems,” he added. “We need a change in thinking and mindsets about the value of nursing.” The State of the World’s Nursing report recommended ten key steps to increase investment in nursing: increase funding to educate and employ more nurses; modernize professional nursing regulation by harmonizing education and practice standards and using systems that can recognize and process nurses’ credentials globally; strengthen capacity to collect, analyze and act on data about the health workforce; monitor nurse mobility and migration and manage it responsibly and ethically; educate and train nurses in the scientific, technological and sociological skills they need to drive progress in primary health care; establish leadership positions including a government chief nurse and support leadership development among young nurses; ensure that nurses in primary health care teams work to their full potential, for example in preventing and managing noncommunicable diseases; improve working conditions including through safe staffing levels, fair salaries, and respecting rights to occupational health and safety; implement gender-sensitive nursing workforce policies; and strengthen the role of nurses in care teams by bringing different sectors (health, education, immigration, finance and labour) together with nursing stakeholders for policy dialogue and workforce planning. In light of the COVID-19 pandemic, which has revealed weaknesses in health systems around the world, implementation of the report’s recommendations is “not optional or ‘nice-to-do’”, it is a “must”, Catton urged. Gauri Saxena contributed to this story Image Credits: Public Services International/Madelline Romero, State of the World's Nursing Report 2020 Executive Summary. COVID-19 Infections Hit One Million Mark; Countries Must Protect Health & Livelihoods During COVID-19 Pandemic Say WHO and IMF 02/04/2020 Svĕt Lustig Vijay As the global count of COVID-19 cases hit the sobering 1 million mark Thursday midnight, countries should not have to face the choice of protecting lives or protecting livelihoods, World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus and International Monetary Fund Managing Director Kristalina Georgieva said at a Friday press briefing. More than half of the new cases reported worldwide were still in WHO’s Europe Region, but an explosion of cases in low- and middle-income countries points to a looming health and economic crises in some of the world’s weakest health systems. “We know that this is much more than a health crisis. We are all aware of the profound social and economic consequences of the pandemic,” said Dr Tedros. “The restrictions many countries have put in place to protect health are taking a heavy toll on the income of individuals and families, the economies of communities and nations”. Countries around the globe have enacted widespread lockdowns in an effort to slow the spread of the virus, forcing businesses and employers to close or scale back operations. Millions of workers, particularly day wage workers, have lost their jobs overnight. “This is a crisis like no other, never in the history of the IMF we have witnessed the world economy coming to a standstill,” said Georgieva. “We are now in recession, it is way worse than the global financial crisis.” Of particular concern are “emerging markets” in developing countries, said IMF’s Georgieva, which are hardest hit and have less resources to protect themselves from both the virus and the global recession. Since the beginning of the pandemic, nearly US $90 billion in capital has left such emerging economies. “Many countries are facing this dilemma of do they provide support to people to survive, or fight the virus,” said Georgieva. “We want to fight this false dilemma.” “The issue of debt in developing countries must be addressed urgently,” she added. The IMF is providing debt relief for its poorest countries through a catastrophic containment relief trust support. Along with the World Bank, the IMF is also calling on bilateral creditors to place a moratorium on official debt payments to provide space for countries to address immediate priorities. Georgieva’s message on debt echoed the moratorium on debt for developing countries put forward by the United Nations Conference on Trade and Development (UNCTD) in Monday’s $2.5 trillion coronavirus crisis package for developing countries. So far, more than 90 countries have applied for emergency financing from the IMF. Rwanda’s request was granted today – and two other African countries requests will likely be approved today, said Georgieva. The IMF aims to double the normal amount of emergency financing offered to countries. On where the funds should be directed in the short term response, Dr Tedros said that governments should be strengthening the foundations of the health system, paying their healthcare workers and removing financial barriers to care, and setting up social welfare support for the most vulnerable. The WHO also voiced their concern today about lifting restrictions too quickly, and the importance of developing effective transition strategies as outbreaks in countries begin to dampen. “If countries rush to lift restrictions quickly, the coronavirus could resurge, and the economic impact could be more severe and prolonged”, said Dr. Tedros. “We don’t want to have cycles of lockdown and release. This is not what anybody needs right now. The way to avoid that is a transition strategy to get ahead of the virus . Like this, we can protect our economies”, said Mike Ryan, Executive Director of the WHO’s Health Emergencies Programme. COVID-19 Surge Past 1,000,000 Cases Worldwide COVID-19 infections hit the one million mark on Thursday evening, according to latest reports by Worldometer, an independent digital team tracking case counts by official national and global sources. COVID-19 hits the one million mark today. More than half of the new cases worldwide over the past 24 hours were still being recorded in WHO’s European region. New cases in Europe totaled 38 809, with Spain, Germany, France, Italy and the UK accounting for almost three quarters of new cases. As France approached the tipping point in demand for intensive care units, a National Ethics Consultation Committee had established “ethical support units” to “help doctors make difficult choices about which patients with “COVID-19 to treat in intensive care”. A summary of the new guidance was also published in English by the British Medical Journal. In the Americas, meanwhile, there were 28 161 new cases over the 24-hour period between 1 April -2 April, largely in the United States. As the USA’s numbers continue to increase to almost 245,573 confirmed cases, the Governor of Florida finally bent to national directives and issued stay-at-home orders for state residents yesterday. Overall, almost 90% (290 million people) of the USA’s population scattered across 37 states have received orders to remain at home. Indian Authorities Call For Provision of Food, Medical Facilities & Clean Drinking Water to Internal Migrants Trends in India as of 13:04 CET. Confirmed cases increase exponentially. Logarithmic curve shown. As India witnessed a massive internal migration of laborers from cities to their rural homes in response to a nation-wide lockdown, India’s Chief Secretary of State, Preeti Sudan, issued an order on behalf of the Ministry of Health and Family Welfare, calling on State Governments to provide adequate medical facilities, food, clean drinking water and sanitation for people on the move. The “anxiety and fear of the migrants should be understood by the police and other authorities and they should deal with the migrants in a humane manner,” stated the order, based on directives issued by India’s Supreme Court. She called on “all concerned to appreciate the trepidation of the poor men, women and children and treat them with kindness.” The migration was occurring as South East Asia experienced a 7-fold increase in new cases in just 24 hours (31 March–1 April). Just three of South-East Asia’s 11 countries, including India (2640), Indonesia (1986) and Thailand (1978) account for about 96% of the cases reported in the region so far. Prime Minister Narendra Modi had earlier announced $US 24 billion package to support India’s vulnerable populations during the COVID-19 crisis; the PM-CARES Fund is supposed to include free food rations for 800 million disadvantaged people, cash transfers for 204 million poor women, and free cooking gas for 80 million households. The fund is being financed by various contributions from other government branches, such as the military and the railways authority, as well as by contributions from government employees and celebrities. Africa’s cases have also increased exponentially in the past week, according to a weekly bulletin the WHO African Regional Office. In comparison to two weeks ago, new cases have almost doubled in the past week (185%), with three more countries reporting COVID-19 (Botswana, Burundi, and Sierra Leone). Currently, most member states in the WHO Africa region (42/45) have confirmed cases of COVID-19. The African region has exceeded 7000 cases today, says Africa’s Centre for Disease Control. Total cases of COVID-19 exceed 1 million as of 7:01:32 PM CET, with active case distribution globally. Numbers change rapidly. New Guidance Issued For Preventing COVID-19 In Refugee And Migrant Camps A new strategy called “shielding”, that aims to limit transmission of COVID-19 in migrant and refugee camps, has been proposed by the London School of Tropical Hygiene and Medicine’s Health in Humanitarian Crises Centre. The strategy recommends that people at high-risk from COVID-19 be identified and separated from other camp members in so-called ‘green-zones’ for an extended period of time, so as to reduce their risks of serious illness and possible death. The zones, ideally, would be located as close as possible to primary health care and other essential services, to minimize their need for movement. The guidance notes that the kinds of ‘stay-at-home’ orders and self-isolation tactics that have been widely adopted in developed countries are unworkable in migrant camps and camp-like settings. And at the same time, overcrowding, poor access to safe water, sanitation and limited access to health services could also lead to very high rates of infection among camp residents. In the guidance, high-risk individuals are defined as those over the age of 60, as well as individuals that have low immunity due to genetic conditions or chronic diseases (e.g. HIV) or non-communicable diseases (NCDs) such as high blood pressure, lung diseases or cancers. “Green Zones” can be established at the household level, as well as at the neighborhood level, or as part of a broader community approach. “Green Zones” can in fact be established at the household level, for older or weaker family members, as well as at the neighborhood level, or as part of a broader community approach – depending on the characteristics of the migrant camp or settlement, the document suggests. The guidance document suggests that “social care committees” can coordinate the shielding response and facilitate acceptance of and adherence to the shielding measures. Grace Ren, Tsering Llamo, and Zixuan Yang contributed to this story Image Credits: London School of Hygiene and Tropical Medicine , COVID-19 India , London School of Hygiene and Tropical Medicine. WHO Nears $675 Million ‘Goal’ For COVID-19 Response – $622 Million Pledged 30/03/2020 Grace Ren & Svĕt Lustig Vijay WHO team of technical experts conclude a COVID-19 support mission to Egypt. The World Health Organization has received more than US $622 million of a US $675 million ask to fund WHO’s first Strategic Preparedness and Response Plan for COVID-19, WHO Director-General Dr Tedros Adhanom Ghebreyesus said on Monday. “We continue to be encouraged by the signs of global solidarity to confront and overcome this common threat,” said Dr Tedros, speaking at an afternoon press briefing. In a parallel development, Norway is leading an initiative to establish a multi-donor fund for the global COVID-19 response to assist developing countries, coordinating with the United Nations to launch the initiative within the next few days. “A multi-donor fund under UN auspices will provide predictability for our partners and help to make the efforts more effective,” said Minister of Foreign Affairs Ine Eriksen Søreide in a press release. ‘Experience from other crises shows that the earlier you start long-term response planning, the more precise and successful the effort becomes.” Unlike the UN Solidarity Fund, which is soliciting donations from individuals and private donors for the response, this fund will collate resources from major bilateral donors and international agencies, similar to the UN Ebola Response Fund set up in 2014 to address the emergency in West Africa. The fund will provide both immediate emergency aid to developing countries, and aid for longer term development initiatives to prop up weak health systems to prepare for future pandemics. In another meeting Monday with Ministers of Trade from the Group of 20 (G20) richest countries in the world, Dr Tedros also called on G20 countries to significantly their increase production of personal protective equipment (PPE), and ensure its equitable distribution of equipment around the world. “Specific attention should be given to low- and middle-income countries in Africa, Asia and Latin America,” said Dr Tedros in a statement. “We call on countries to work with companies to increase production; to ensure the free movement of essential health products; and to ensure equitable distribution of those products, based on need.” However, hoarding and misappropriation of donated PPE equipment also may loom as a thorny problems that donors need to resolve. At the China-Uganda Friendship Referral Hospital near Kampala, one of three Ugandan reference hospitals for COVID-19 cases, health workers taking throat swabs from suspected COVID-19 patients and managing an isolation ward, lack basic protective gear except gloves, Health Policy Watch learned. N-95 masks must be purchased by the doctors and nurses out of pocket, and protective gowns and face shields are unavavilable. Gloves were provided by the hospital after workers threatened to strike, but when supplies run low, patients have to pay for those themselves before they are examined. WHO did not comment on the report. 154 NGOs Submit Open Letter Calling For Gilead To Retract Remdesivir Patent Applications Some 154 NGOs released an open letter Monday calling for Gilead Sciences to rescind its patent applications for remdesivir in 70 countries that could grant the company market exclusivity until 2031 on the experiemental drug, a promising potential COVID-19 treatment. The campaign, coordinated by Médecins Sans Frontières (MSF), aligns closely with a growing movement within the medicines access community to push for mandatory “pooled” rights for COVID-19 technologies. In an unusual move, Gilead already asked the US FDA to rescind special “orphan drug” status for remdesivir last week after facing an intense public backlash, just days after recieving the designation. Orphan drug status would have granted Gilead an addition 7 years of market exclusivity. However, according to the MSF statement, the company still has pending patent applications for remdesivir in at least 70 other countries. “It is unacceptable for Gilead’s remdesivir to be put under the company’s exclusive control, taking into account that the drug was developed with considerable public funding for both early-stage research and clinical trials; the extraordinary efforts and personal risks that both healthcare workers and patients have faced in using the medicine in clinical trial settings; and the unprecedented disaster all countries are facing for their people, their healthcare systems, and their economies” said Medecins Sans Frontieres (MSF) in a statement today. In the open letter, Gilead was urged to take immediate action in the public interest by declaring that it will drop all exclusive rights on patents, regulatory and trial data, as well as making all data required for development of generic drug versions publically available to enable their production and supply. Finally, Gilead was requested to improve its transparency by disclosing its existing supply and manufacturing capacity. “There is a further step to take, as a voluntary pool may not be sufficient, especially when the crisis intensity cools and public approbation for actions like Gilead’s Orphan designation abates,” said Paul Fehlner, President & CEO of reVision Therapeutics, in an interview with Health Policy Watch. “An entity dedicated to the public interest could obtain consequential legal exclusivities (Orphan drug designation, data and market exclusivity) and prevent opportunistic third parties from getting them”. According to Fehlner, creating a “pool” of rights would take minimum efforts, only requiring a willing coordinator to “aggregate data from ongoing trials worldwide and submit formal applications to health authorities.” “This crisis presents an immediate and urgent opportunity to wield the tools of exclusivity to promote access to medical products that may combat COVID-19,” said Fehlner. COVID-19 Trends As the United States now leads the world in coronavirus cases with 143,055 confirmed cases and 2,513 deaths according to the Johns Hopkins tracking database, President Trump extended the U.S. social distancing guidelines until the end of April, rescinding his earlier predictions that the lockdown would end by mid-April’s Easter holiday. Meanwhile, the UN donated 250,000 protective face masks to the USA from its New York headquarters to help combat the outbreak’s epicenter in New York. As the US is faced with rapidly increasing cases, inefficiencies from failed coronavirus tests, and shortage of ventilators, STATNews reports that the Genomics Institute led by Jennifer Doudna, the pioneer of CRISPR gene editing technology, will start running coronavirus tests in order to increase the turnaround time of testings in the San Francisco Bay Area. Over the weekend, Italy and Spain bolster efforts to curb the spread of the coronavirus and flatten the curve. Italy, numbers 97,689 cases and 10,779 deaths, and Spain, numbers 85,195 cases and 7,340 deaths, have overtaken China’s 82,198 cases and 3,308 deaths according to the Johns Hopkins coronavirus tracking database. As infection increases, Italy has decided to extend its national lockdown beyond the April 3rd date while Spain tightens the national lockdown for all citizens, except for the workers in the essential sectors until April 9th. As the rate of infection within countries intensified, European countries began to depart from longstanding WHO guidance against the wearing of masks by the general public. Notably, Austria made masks obligatory for clients in supermarkets mandatory to curb airborne spread of the coronavirus amongst customers. Crowded supermarkets have been identified in a number of countries as nexus points for virus spread. However, until now, universal masking has only been practiced in Asia, while WHO repeatedly said the measure was unecessary elsewhere. The Hungarian Parliament, meanwhile, awarded wide-ranging powers to Prime Minister Viktor Orban for an indefinite period, to fight the pandemic, including curtailing free speech and other democratic rights. South-East and Western Asia In South-East Asia, the coronavirus was increasingly disrupting the lives of those living on the socioeconomic margins. After Prime Minister Modi’s surprise lockdown announcement, India’s daily wage earners struggle under the nationwide lockdown as many are stranded in cities without food, housing, and means of getting back home, particularly vulnerable are the Muslim minority who have been victims of recent riots over amendments to the naional citizenship bill. The challenges faced by the rural Indian migrants in the megacities post-lockdown has initiated one of the largest exodus of people back into the rural areas. Meanwhile, in the Western Pacific Region, the International Olympic Committee (IOC) postpones the Tokyo Summer Olympics to July 23rd, 2021 to August 8th, 2021. Online debates also continued to swirl around the degree of China’s influence on the WHO. On Sunday, Taiwan’s Foreign Minister Joseph Wu tweeted a complaint referring a senior WHO official’s response to a question from a Hong Kong journalist, about whether WHO would reconsider Taiwan application for member state status. “Wow, can’t even utter ‘Taiwan’ in the WHO? You should set politics aside in dealing with a pandemic,” Wu wrote. Taiwan has accused WHO of ignoring its early warnings about the appearance of a novel coronavirus in mainland China, as well as brushing aside subsequent criticism that China repressed early news about the virus spread, which delayed a more systematic public health response. Overall, Europe continued to lead with half or more of the now active COVID-19 cases worldwide, followed by the United States. There were some 30,000 active cases in the Eastern Mediterranean Region, including heavily hit Iran. South-East Asia was reporting nearly 3,600 active cases, and in WHO’s Africa region, there were more than 3,300 infections reported. In the Western Pacific Region, there were some 18,095 active cases, but only about 3,000 of those were in mainland China. Total cases of COVID-19 as of 8 p.m CET, with active case distribution globally. Numbers change rapidly. -Tsering Lhamo contributed to this report. Image Credits: WHO EMRO. Blood Plasma Of Recovered COVID-19 Patients Approved By US FDA For Investigational Use As Treatment 25/03/2020 Grace Ren Technician separates blood components into plasma, platelets, and red blood cells. The US Food and Drug Administration granted investigational emergency use approval for convalescent blood plasma as a potential COVID-19 treatment on Tuesday. Cloned antibodies from recovered COVID-19 patients showed impressive ability to neutralize SARS-CoV-2, the virus behind the disease, in cell cultures, according to a paper published Wednesday on the preprint server BioRxiv. Two of the most potent antibodies isolated, 299 P2C-1F11 and P2B-2F6, were able to bind so strongly to the virus that it reduced the percentage of virus attaching to live cells by almost 100%. Patients who have recovered from COVID-19 have antibodies in their blood that might be effective against the infection. These antibodies, found in the blood plasma – or the transparent, liquid part of the blood – could be then injected into COVID-19 patients to provide some immunity as the host immune system ramps up its own response. Early evidence from a Chinese trial in 10 patients showed “significant improvement” within 1 to 3 days after receiving a blood plasma transfusion, with 2 of the 3 patients weaned off mechanical ventilation shortly after the transfusion. New York State, which has about half of the 62,873 COVID-19 cases in the United States, is set to roll-out the first treatments within the next week, Governor Andrew Cuomo said on Monday. According to CNN, New York will be first recruiting recovered patients from New Rochelle, which saw the first cluster of cases in the state and thus has the largest cluster of recovered COVID-19 patients eligible to donate blood. Although promising, convalescent blood plasma is not effective for every disease, says the US FDA, including for viral diseases such as Ebola. Success in cell culture studies must still be replicated in human patients. However, experts have been pushing since January for more serious consideration of such treatment as a potential COVID-19 treatment, based on limited success in treating other coronaviruses, such as SARS and MERS. Under US FDA regulations, the treatment is only available to patients with a lab confirmed positive COVID-19 test experiencing severe disease, and enrolled in a clinical trial. A recovered patient with a prior lab-confirmed COVID19 diagnosis may donate blood plasma 2 weeks after their symptoms resolve, and only if they then test negative for COVID-19. The collected blood plasma can then be immediately infused into COVID-19 patients with severe disease, after the donation is screened for other blood-borne diseases. Other trials of blood plasma or plasma-derived products are already taking place at the University of Washington in St. Louis, Missouri. Scientists there submitted a investigational new drug application to the FDA on 18 March. In a related development, the pharma firm Takeda announced on 4 March that the company initiated development of an antibody treatment derived from plasma. 61 Organizations Call On EU To Ensure Accessibility of New Coronavirus Products Some 61 NGOs released an open letter on Wednesday calling on the European Union and national governments to incorporate access and affordability products into approvals for new COVID-19 products. The groups also said that governments should exclusive licensing, and require disclosure of public contributions to drug development as part of COVID-19 research. “In the current pandemic situation when time is of the essence and it is critical that any treatment developed with public funds is made as widely available as possible, the call for greater transparency and accountability for public funds used in biomedical R&D is particularly pertinent,” said Jaume Vidal, senior policy advisor at Health Action International, the access organization that coordinated the letter, in an interview with Health Policy Watch. Vidal added that making COVID-19 drugs as widely available as possible “necessarily entails” affordability requirements, and that the ask on non-exclusive licensing was a “specific demand to counter” medicines shortages, which can be caused by limiting the number of producers. A recent fast-track US $45 million call for proposals on developing therapeutics and diagnostics for COVID-19 by the Innovative Medicine Initiative (IMI) did not require affordability clauses, according to the letter. Affordability clauses help ensure that any successful products developed by grant money are not priced out of reach of low- or middle-income countries, or poorer health systems. Additionally, the NGOs said that granting exclusive licenses for successful COVID-19 product should not be allowed, just days after the US FDA granted Gilead’s remdesivir, a promising coronavirus antiviral, “orphan drug” status – giving the pharma company 7 years of US market exclusivity. However in an unusual about-face, the company requested the FDA rescind the “orphan drug” designation on Wednesday after facing a public backlash from medicines access advocates. The open letter said that market exclusivity on COVID-19 products could create “excessively high prices or over-reliance on a single source, which can increase the possibility of shortages. “An effective response requires that all these necessary medical tools are free of charge at the point of delivery, particularly for vulnerable populations,” the organizations stated in the letter. Europe Remains the Epicentre, But Some Countries Can Still Stem the Tide. The letter was released as active cases in Europe surged to 197,842 cases and 12,822 total deaths. Italy and Spain remain the worst affected countries with 54,030 and 40,382 active cases respectively; however, Switzerland with 9765 cases has now overtaken Italy to have the highest number of cases per capita. In Italy, fatalities rose to 743 deaths, after several days of lower numbers. Prime Minister Giuseppe Conte increased fines for leaving homes to up to 3,000 euros from the previous maximum of 206 euros. In Spain, an ice rink in Madrid has been converted into a temporary morgue, according to El Paiz. Meanwhile, across the Atlantic, cases shot up in the United States to 62,873, with 30,811 alone in New York State. The uptick of cases in the state is also driven by increased testing. The state is testing more than 16,000 people a day, a higher per capita testing rate than even China or South Korea, according to a press release from Governor Andrew Cuomo’s office. However, other states in the US are still facing test kit shortages – amid mixed messages from the White House on whether most US workers will be able to return to their jobs again by Easter. In Latin America, Brazil remains the most affected country at 2155 cases followed by Chile with 903 and Ecuador with 775 cases. As the number of cases escalates in Chile, the government is facing pressure to introduce a national lockdown, following in Argentina’s footsteps, according to National Public Radio. Chilean President Sebastian Piñera has declared the situation as “a state of catastrophe” and has deployed the armed forces to maintain infrastructure and supply lines. According to the latest WHO situation report, the total number of cases in the WHO African Region is 1305 -315 more than the previous day – and deaths increased from 23 to 26. South Africa, Algeria and Burkina Faso are the most affected countries in the region with 402, 231 and 99 cases respectively. President of the Democratic Republic of the Congo Felix Tshisekedi declared a “state of emergency” Wednesday morning as the case count hit 45 cases and 3 deaths, closing country borders and banning all flights, even domestic ones, from entering Kinshasa, in an attempt to lock down the country’s dense urban center. However, according to World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, around the world more than 150 countries still have less than 100 cases – and those nations still had a chance to prevent widespread disruptions from COVID-19. “Aggressive measures to find, isolate, test, treat and trace are not only the best and fastest way out of extreme social and economic restrictions – they’re also the best way to prevent them,” said Dr Tedros. Active cases around the world as of 11PM CET 25 March. Right column shows cumulative case count. Numbers are rapidly changing. This story was updated 27 March 2020. Image Credits: Banc de Sang i Teixits, Johns Hopkins CSSE. Médecins Sans Frontières Announces Campaign For $5 COVID-19 Test On ‘GeneXpert’ TB Platform 24/03/2020 Grace Ren Healthcare worker runs a test on a GeneXpert machine. Médecins Sans Frontiéres (MSF) on Tuesday launched a campaign to push for a US $5 price tag on a new COVID-19 rapid diagnostic test that can be used on GeneXpert, a diagnostic instrument widely deployed around the world for diagnosing tuberculosis. The test for SARS-CoV-2, the virus that causes COVID-19, received US Food and Drug Administration emergency use approval just last Friday, and represents a hope for scaling up COVID-19 testing in low- and middle-income countries. The MSF announcement coincided with World Tuberculosis Day, and reflected one of the many ways in which the battle against one of the world’s oldest respiratory diseases, TB and the battle against the newest threat to lung health from COVID-19, are now converging. “The Xpert Xpress SARS-CoV-2 Test for testing for the novel coronavirus should be no more than $5 a cartridge,” said Sharonann Lynch, HIV and TB Policy Advisor at Médecins Sans Frontiéres/Doctors Without Borders’ Access Campaign, in an interview with Health Policy Watch. The US company that produces GeneXpert tests Cepheid has set the coronavirus test price at $19.80 per cartridge for 145 developing countries, according to Lynch. In high income countries, the coronavirus test will cost $35 per cartridge. The TB test for the platform currently costs $9.98 per cartridge for low- and middle- income countries. An HIV diagnostic test, which can also be performed on the platform, costs $14 per cartridge. However, even the US $10 price on the TB test is too high for many countries, said Lynch. Thus, Cepheid could “drastically lower the price to $5 per test.” An assessment of other GeneXpert tests by MSF and Cambridge Consultants found that a US $5 price tag per cartridge could still generate profit for Cepheid, as the ‘cost of goods’ – or the cost of materials, manufacturing, labour, overhead, intellectual property, and other indirect expenses – is estimated to be only US $3. The campaign for a $US 5 coronavirus test is an extension of an existing ‘Time for 5’ campaign by MSF to knock down prices for TB and HIV test cartridges to US $5 a piece. WHO Releases New Guidelines For Preventative TB Treatment Also on World Tuberculosis Day, the World Health Organization released new guidelines to scale up new, and dramatically shorter preventative regimens for latent tuberculosis (TB), one of mankind’s oldest and deadliest diseases. “COVID-19 is highlighting just how vulnerable people with lung diseases and weakened immune systems can be,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Millions of people need to be able to take TB preventative treatment to stop the onset of disease, avert suffering, and save lives.” In the context of the COVID-19 pandemic, “early evidence suggests that people with TB will be more susceptible to coronavirus and severe COVID-19,” said Lynch. Thus, scaling up preventative TB treatment could also help reduce negative impacts of the rapidly accelerating COVID-19 pandemic according to the WHO, which has also released guidance on how to sustain TB treatment during the COVID-19 emergency. Tuberculosis remains the world’s top infectious killer – in 2018 there were an estimated 10 million new symptomatic infections and 1.5 million deaths. About a quarter of the world’s population is estimated to be infected with TB bacteria, but are not sick nor contagious. However, those with such “latent” TB are at higher risk of developing active disease, which can be particularly deadly in immunocompromised people. Treating latent TB remains the most effective strategy to prevent the progression to active disease and protect others against onwards transmission – but has been largely neglected as a part of TB control programmes. To date, only 430,000 of the target 24 million contacts of people with active TB and only 1.8 million of the target 6 million people living with HIV have received preventative treatment. The new WHO guidelines recommend new shorter regimens for preventative treatment for latent forms of the disease, ranging from a 1 month daily rifapentine/isoniazid treatment to 4 months of daily rifampicin alone – shaving off months from the previous standard 6-month isoniazid treatment. The guidelines also recommend the rapid scale-up of preventative TB treatment among populations at highest risk, including household contacts of TB patients, people living with HIV, and those with lowered immunity or living in crowded settings; integrating TB preventative treatment into case-finding efforts for active TB, and using tuberculin skin tests or an interferon-gamma release assay (IGRA) to test for infection when tests are available. Woman puts on a facemask at a healthcare facility for drug-resistant TB patients in New Delhi, India Leveraging TB Knowledge To Fight COVID-19 As the COVID-19 pandemic accelerates, the World Health Organization and leading TB organizations also are promoting a joint approach to tackling both the world’s oldest and newest respiratory threats. New WHO guidance for TB programme directors recommends leveraging TB prevention strategies, technologies and logistics, and programmatic staff to tackle the diseases. TB staff, with years of experience in low-resource settings, are well positioned to offer technical assistance in contact tracing and active case finding, the cornerstones of a robust COVID-19 response. “We know what works to fight COVID-19 from our experience and the tools we have developed to end TB: infection control, wide-spread testing, contact tracing, X-rays, artificial intelligence, telemedicine and psycho-social support,” said José Luis Castro, executive director of The International Union Against TB and Lung Diseases (The Union) in a press release. However, some TB advocates have also expressed concerns that the global focus on COVID-19 could shift resources from essential TB treatment services. “The COVID emergency should marshall all necessary resources, but not at the expense of TB services, including TB testing, or people with TB,” said Lynch. Additionally, with countries enacting more strict travel restrictions in the face of accelerating COVID-19 outbreaks, it may be time to try a new model of care for TB patients For those with active TB, a full treatment course is at least 6 months and treatment is usually directly observed by providers, which means patients or healthcare workers must travel daily to meet in clinics or homes to administer treatment. “To reduce the risk for existing patients, [we] must seek ways to re-design models of care to provide treatment for people with TB in the community and use remote telemedicine and web apps to support them,” Lynch suggested. Image Credits: WHO/UNITAID, CNS Images. As Coronavirus Spreads, It’s Time To Diagnose & Treat Our Broken Primary Health Care Systems 24/03/2020 Dan Schwarz & Beth Tritter Staff members administering vaccinations at Kabuga Health Center in the Gasabo district of Kigali (Rusororo sector), Rwanda on June 28, 2018. As the explosive impact of COVID-19 ripples globally, there’s a clear plea from many regions and countries: stay home and help “flatten the curve” of infection. People from China to Italy have seen the consequences of the virus spreading too quickly with hospitals overwhelmed and doctors forced to make heartbreaking decisions about who lives and dies. It’s natural to hear these stories and blame a lack of pandemic preparedness. But emergency response can only go so far if the health system’s first line of defense – primary health care – isn’t up to the task. Experts have already called attention to gaps in front line health supplies, such as masks, hand sanitizer, testing kits and vaccines. In the U.S., where we live, these gaps mean we’re now fighting a steep uphill battle in containing the virus. But few are talking about shortcomings of the primary health care system, which is about far more than just supplies. Strong primary health care looks like a trusted nurse or doctor, who is always there and trained to answer your questions. It means comprehensive quality care – in one place – tailored to your health needs. It means confidence that your local health center is safe and ready with quality medicines and supplies, regardless of outbreaks or changes in the world around you. Whether or not a crisis is looming, primary health care should be the first place everyone turns for health services or information, using hospitals only when truly necessary. For most people worldwide, though, access to quality primary health care depends on where you live or how much money you have. In fact, primary health care is chronically underfunded and deprioritized in rich and poor countries alike. COVID-19 has made it painfully clear that we can’t afford to have weak primary health care continue as our reality. In the U.S., fragmented care and lack of clear communication from experts has left people anxious about where to turn, making unnecessary visits to emergency rooms. In Italy, where the health care system has experienced cuts in funding over the past decade, we’re seeing the dire consequences of having too few staff and supplies. And across Africa, where the virus is rapidly spreading, misinformation and mistrust of health systems could keep people from seeking care – as we saw in Liberia and other West African countries during the 2014-2016 Ebola outbreak. This doesn’t have to be the case. There are clear steps the world can take to fully unlock the potential of primary health care, both to help us respond to the current pandemic and prepare for disease outbreaks we’ll inevitably face in the future. In the short-term, primary care providers should be considered central partners and first responders in this crisis, helping to test and triage the most at-risk patients, and reducing the burden on already-overwhelmed hospitals. Leaders owe them reliable information and tools, including additional support for logistics and staffing and critical supplies such as rapid test kits and personal protective equipment. Such approaches have paid off in a big way in countries like Singapore, where they’ve been able to mobilize a trusted and well-resourced primary health care workforce. Trusted primary care providers can also play a key role disseminating prevention messages to the public and high-risk groups, and encouraging social distancing by offering telehealth services for people with COVID-19 symptoms and chronic disease patients alike. In the weeks and months ahead, countries and donors should also resist the urge to earmark all response funds for coronavirus-specific care. As health systems approach breaking point, flexible funds for primary health care can aid the response and prevent disruptions to essential daily life-saving services, from delivering babies to treating chronic conditions. This approach will also help head off future epidemics, rather than promote a continuous cycle of “Band-Aid” investments that ignore the root of the problem. In the long term, governments must significantly increase spending on quality primary health care to make sure it’s well-resourced and affordable – so that no one has to choose between seeking care and paying their bills. The World Health Organization estimates that it will take an additional $200 billion annually to fund quality primary health care for all; well-spent, this could save 60 million lives in low- and middle-income countries alone. Finally, we can’t fix problems that we can’t diagnose. Countries desperately need better ways to take the temperature of their primary health care systems. At the Primary Health Care Performance Initiative, a partnership of country policymakers, health systems managers and advocates, we’re working with governments around the world to collect more and better data, equipping leaders to pinpoint weaknesses and improve health systems before the next pandemic hits. Counting treatments or people infected is not enough – we need to know if people trust and value their care; if health workers are trained, resourced and motivated; and if clinics are safe, clean and well-managed. We are only as prepared as the world’s weakest health system. The world has repeatedly failed to learn this before. We must do better beginning today, or this won’t be the last time we pay the price. ______________________________________________________________________________ Dan Schwarz, MD MPH is the Director of Primary Health Care at Ariadne Labs and an Adviser to the WHO and the Lancet Commission on Noncommunicable Diseases and Poverty, with over a decade of experience in global healthcare delivery. Beth Tritter is the Executive Director of the Primary Health Care Performance Initiative (PHCPI). PHCPI was founded in 2015 by the Bill & Melinda Gates Foundation, the World Health Organization and the World Bank Group, and now including UNICEF, in collaboration with Ariadne Labs and Results for Development. She previously served in the U.S. government as the Millennium Challenge Corporation’s Vice President for Policy and Evaluation. Image Credits: Bill & Melinda Gates Foundation/Samantha Reinders. WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
COVID-19 Infections Hit One Million Mark; Countries Must Protect Health & Livelihoods During COVID-19 Pandemic Say WHO and IMF 02/04/2020 Svĕt Lustig Vijay As the global count of COVID-19 cases hit the sobering 1 million mark Thursday midnight, countries should not have to face the choice of protecting lives or protecting livelihoods, World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus and International Monetary Fund Managing Director Kristalina Georgieva said at a Friday press briefing. More than half of the new cases reported worldwide were still in WHO’s Europe Region, but an explosion of cases in low- and middle-income countries points to a looming health and economic crises in some of the world’s weakest health systems. “We know that this is much more than a health crisis. We are all aware of the profound social and economic consequences of the pandemic,” said Dr Tedros. “The restrictions many countries have put in place to protect health are taking a heavy toll on the income of individuals and families, the economies of communities and nations”. Countries around the globe have enacted widespread lockdowns in an effort to slow the spread of the virus, forcing businesses and employers to close or scale back operations. Millions of workers, particularly day wage workers, have lost their jobs overnight. “This is a crisis like no other, never in the history of the IMF we have witnessed the world economy coming to a standstill,” said Georgieva. “We are now in recession, it is way worse than the global financial crisis.” Of particular concern are “emerging markets” in developing countries, said IMF’s Georgieva, which are hardest hit and have less resources to protect themselves from both the virus and the global recession. Since the beginning of the pandemic, nearly US $90 billion in capital has left such emerging economies. “Many countries are facing this dilemma of do they provide support to people to survive, or fight the virus,” said Georgieva. “We want to fight this false dilemma.” “The issue of debt in developing countries must be addressed urgently,” she added. The IMF is providing debt relief for its poorest countries through a catastrophic containment relief trust support. Along with the World Bank, the IMF is also calling on bilateral creditors to place a moratorium on official debt payments to provide space for countries to address immediate priorities. Georgieva’s message on debt echoed the moratorium on debt for developing countries put forward by the United Nations Conference on Trade and Development (UNCTD) in Monday’s $2.5 trillion coronavirus crisis package for developing countries. So far, more than 90 countries have applied for emergency financing from the IMF. Rwanda’s request was granted today – and two other African countries requests will likely be approved today, said Georgieva. The IMF aims to double the normal amount of emergency financing offered to countries. On where the funds should be directed in the short term response, Dr Tedros said that governments should be strengthening the foundations of the health system, paying their healthcare workers and removing financial barriers to care, and setting up social welfare support for the most vulnerable. The WHO also voiced their concern today about lifting restrictions too quickly, and the importance of developing effective transition strategies as outbreaks in countries begin to dampen. “If countries rush to lift restrictions quickly, the coronavirus could resurge, and the economic impact could be more severe and prolonged”, said Dr. Tedros. “We don’t want to have cycles of lockdown and release. This is not what anybody needs right now. The way to avoid that is a transition strategy to get ahead of the virus . Like this, we can protect our economies”, said Mike Ryan, Executive Director of the WHO’s Health Emergencies Programme. COVID-19 Surge Past 1,000,000 Cases Worldwide COVID-19 infections hit the one million mark on Thursday evening, according to latest reports by Worldometer, an independent digital team tracking case counts by official national and global sources. COVID-19 hits the one million mark today. More than half of the new cases worldwide over the past 24 hours were still being recorded in WHO’s European region. New cases in Europe totaled 38 809, with Spain, Germany, France, Italy and the UK accounting for almost three quarters of new cases. As France approached the tipping point in demand for intensive care units, a National Ethics Consultation Committee had established “ethical support units” to “help doctors make difficult choices about which patients with “COVID-19 to treat in intensive care”. A summary of the new guidance was also published in English by the British Medical Journal. In the Americas, meanwhile, there were 28 161 new cases over the 24-hour period between 1 April -2 April, largely in the United States. As the USA’s numbers continue to increase to almost 245,573 confirmed cases, the Governor of Florida finally bent to national directives and issued stay-at-home orders for state residents yesterday. Overall, almost 90% (290 million people) of the USA’s population scattered across 37 states have received orders to remain at home. Indian Authorities Call For Provision of Food, Medical Facilities & Clean Drinking Water to Internal Migrants Trends in India as of 13:04 CET. Confirmed cases increase exponentially. Logarithmic curve shown. As India witnessed a massive internal migration of laborers from cities to their rural homes in response to a nation-wide lockdown, India’s Chief Secretary of State, Preeti Sudan, issued an order on behalf of the Ministry of Health and Family Welfare, calling on State Governments to provide adequate medical facilities, food, clean drinking water and sanitation for people on the move. The “anxiety and fear of the migrants should be understood by the police and other authorities and they should deal with the migrants in a humane manner,” stated the order, based on directives issued by India’s Supreme Court. She called on “all concerned to appreciate the trepidation of the poor men, women and children and treat them with kindness.” The migration was occurring as South East Asia experienced a 7-fold increase in new cases in just 24 hours (31 March–1 April). Just three of South-East Asia’s 11 countries, including India (2640), Indonesia (1986) and Thailand (1978) account for about 96% of the cases reported in the region so far. Prime Minister Narendra Modi had earlier announced $US 24 billion package to support India’s vulnerable populations during the COVID-19 crisis; the PM-CARES Fund is supposed to include free food rations for 800 million disadvantaged people, cash transfers for 204 million poor women, and free cooking gas for 80 million households. The fund is being financed by various contributions from other government branches, such as the military and the railways authority, as well as by contributions from government employees and celebrities. Africa’s cases have also increased exponentially in the past week, according to a weekly bulletin the WHO African Regional Office. In comparison to two weeks ago, new cases have almost doubled in the past week (185%), with three more countries reporting COVID-19 (Botswana, Burundi, and Sierra Leone). Currently, most member states in the WHO Africa region (42/45) have confirmed cases of COVID-19. The African region has exceeded 7000 cases today, says Africa’s Centre for Disease Control. Total cases of COVID-19 exceed 1 million as of 7:01:32 PM CET, with active case distribution globally. Numbers change rapidly. New Guidance Issued For Preventing COVID-19 In Refugee And Migrant Camps A new strategy called “shielding”, that aims to limit transmission of COVID-19 in migrant and refugee camps, has been proposed by the London School of Tropical Hygiene and Medicine’s Health in Humanitarian Crises Centre. The strategy recommends that people at high-risk from COVID-19 be identified and separated from other camp members in so-called ‘green-zones’ for an extended period of time, so as to reduce their risks of serious illness and possible death. The zones, ideally, would be located as close as possible to primary health care and other essential services, to minimize their need for movement. The guidance notes that the kinds of ‘stay-at-home’ orders and self-isolation tactics that have been widely adopted in developed countries are unworkable in migrant camps and camp-like settings. And at the same time, overcrowding, poor access to safe water, sanitation and limited access to health services could also lead to very high rates of infection among camp residents. In the guidance, high-risk individuals are defined as those over the age of 60, as well as individuals that have low immunity due to genetic conditions or chronic diseases (e.g. HIV) or non-communicable diseases (NCDs) such as high blood pressure, lung diseases or cancers. “Green Zones” can be established at the household level, as well as at the neighborhood level, or as part of a broader community approach. “Green Zones” can in fact be established at the household level, for older or weaker family members, as well as at the neighborhood level, or as part of a broader community approach – depending on the characteristics of the migrant camp or settlement, the document suggests. The guidance document suggests that “social care committees” can coordinate the shielding response and facilitate acceptance of and adherence to the shielding measures. Grace Ren, Tsering Llamo, and Zixuan Yang contributed to this story Image Credits: London School of Hygiene and Tropical Medicine , COVID-19 India , London School of Hygiene and Tropical Medicine. WHO Nears $675 Million ‘Goal’ For COVID-19 Response – $622 Million Pledged 30/03/2020 Grace Ren & Svĕt Lustig Vijay WHO team of technical experts conclude a COVID-19 support mission to Egypt. The World Health Organization has received more than US $622 million of a US $675 million ask to fund WHO’s first Strategic Preparedness and Response Plan for COVID-19, WHO Director-General Dr Tedros Adhanom Ghebreyesus said on Monday. “We continue to be encouraged by the signs of global solidarity to confront and overcome this common threat,” said Dr Tedros, speaking at an afternoon press briefing. In a parallel development, Norway is leading an initiative to establish a multi-donor fund for the global COVID-19 response to assist developing countries, coordinating with the United Nations to launch the initiative within the next few days. “A multi-donor fund under UN auspices will provide predictability for our partners and help to make the efforts more effective,” said Minister of Foreign Affairs Ine Eriksen Søreide in a press release. ‘Experience from other crises shows that the earlier you start long-term response planning, the more precise and successful the effort becomes.” Unlike the UN Solidarity Fund, which is soliciting donations from individuals and private donors for the response, this fund will collate resources from major bilateral donors and international agencies, similar to the UN Ebola Response Fund set up in 2014 to address the emergency in West Africa. The fund will provide both immediate emergency aid to developing countries, and aid for longer term development initiatives to prop up weak health systems to prepare for future pandemics. In another meeting Monday with Ministers of Trade from the Group of 20 (G20) richest countries in the world, Dr Tedros also called on G20 countries to significantly their increase production of personal protective equipment (PPE), and ensure its equitable distribution of equipment around the world. “Specific attention should be given to low- and middle-income countries in Africa, Asia and Latin America,” said Dr Tedros in a statement. “We call on countries to work with companies to increase production; to ensure the free movement of essential health products; and to ensure equitable distribution of those products, based on need.” However, hoarding and misappropriation of donated PPE equipment also may loom as a thorny problems that donors need to resolve. At the China-Uganda Friendship Referral Hospital near Kampala, one of three Ugandan reference hospitals for COVID-19 cases, health workers taking throat swabs from suspected COVID-19 patients and managing an isolation ward, lack basic protective gear except gloves, Health Policy Watch learned. N-95 masks must be purchased by the doctors and nurses out of pocket, and protective gowns and face shields are unavavilable. Gloves were provided by the hospital after workers threatened to strike, but when supplies run low, patients have to pay for those themselves before they are examined. WHO did not comment on the report. 154 NGOs Submit Open Letter Calling For Gilead To Retract Remdesivir Patent Applications Some 154 NGOs released an open letter Monday calling for Gilead Sciences to rescind its patent applications for remdesivir in 70 countries that could grant the company market exclusivity until 2031 on the experiemental drug, a promising potential COVID-19 treatment. The campaign, coordinated by Médecins Sans Frontières (MSF), aligns closely with a growing movement within the medicines access community to push for mandatory “pooled” rights for COVID-19 technologies. In an unusual move, Gilead already asked the US FDA to rescind special “orphan drug” status for remdesivir last week after facing an intense public backlash, just days after recieving the designation. Orphan drug status would have granted Gilead an addition 7 years of market exclusivity. However, according to the MSF statement, the company still has pending patent applications for remdesivir in at least 70 other countries. “It is unacceptable for Gilead’s remdesivir to be put under the company’s exclusive control, taking into account that the drug was developed with considerable public funding for both early-stage research and clinical trials; the extraordinary efforts and personal risks that both healthcare workers and patients have faced in using the medicine in clinical trial settings; and the unprecedented disaster all countries are facing for their people, their healthcare systems, and their economies” said Medecins Sans Frontieres (MSF) in a statement today. In the open letter, Gilead was urged to take immediate action in the public interest by declaring that it will drop all exclusive rights on patents, regulatory and trial data, as well as making all data required for development of generic drug versions publically available to enable their production and supply. Finally, Gilead was requested to improve its transparency by disclosing its existing supply and manufacturing capacity. “There is a further step to take, as a voluntary pool may not be sufficient, especially when the crisis intensity cools and public approbation for actions like Gilead’s Orphan designation abates,” said Paul Fehlner, President & CEO of reVision Therapeutics, in an interview with Health Policy Watch. “An entity dedicated to the public interest could obtain consequential legal exclusivities (Orphan drug designation, data and market exclusivity) and prevent opportunistic third parties from getting them”. According to Fehlner, creating a “pool” of rights would take minimum efforts, only requiring a willing coordinator to “aggregate data from ongoing trials worldwide and submit formal applications to health authorities.” “This crisis presents an immediate and urgent opportunity to wield the tools of exclusivity to promote access to medical products that may combat COVID-19,” said Fehlner. COVID-19 Trends As the United States now leads the world in coronavirus cases with 143,055 confirmed cases and 2,513 deaths according to the Johns Hopkins tracking database, President Trump extended the U.S. social distancing guidelines until the end of April, rescinding his earlier predictions that the lockdown would end by mid-April’s Easter holiday. Meanwhile, the UN donated 250,000 protective face masks to the USA from its New York headquarters to help combat the outbreak’s epicenter in New York. As the US is faced with rapidly increasing cases, inefficiencies from failed coronavirus tests, and shortage of ventilators, STATNews reports that the Genomics Institute led by Jennifer Doudna, the pioneer of CRISPR gene editing technology, will start running coronavirus tests in order to increase the turnaround time of testings in the San Francisco Bay Area. Over the weekend, Italy and Spain bolster efforts to curb the spread of the coronavirus and flatten the curve. Italy, numbers 97,689 cases and 10,779 deaths, and Spain, numbers 85,195 cases and 7,340 deaths, have overtaken China’s 82,198 cases and 3,308 deaths according to the Johns Hopkins coronavirus tracking database. As infection increases, Italy has decided to extend its national lockdown beyond the April 3rd date while Spain tightens the national lockdown for all citizens, except for the workers in the essential sectors until April 9th. As the rate of infection within countries intensified, European countries began to depart from longstanding WHO guidance against the wearing of masks by the general public. Notably, Austria made masks obligatory for clients in supermarkets mandatory to curb airborne spread of the coronavirus amongst customers. Crowded supermarkets have been identified in a number of countries as nexus points for virus spread. However, until now, universal masking has only been practiced in Asia, while WHO repeatedly said the measure was unecessary elsewhere. The Hungarian Parliament, meanwhile, awarded wide-ranging powers to Prime Minister Viktor Orban for an indefinite period, to fight the pandemic, including curtailing free speech and other democratic rights. South-East and Western Asia In South-East Asia, the coronavirus was increasingly disrupting the lives of those living on the socioeconomic margins. After Prime Minister Modi’s surprise lockdown announcement, India’s daily wage earners struggle under the nationwide lockdown as many are stranded in cities without food, housing, and means of getting back home, particularly vulnerable are the Muslim minority who have been victims of recent riots over amendments to the naional citizenship bill. The challenges faced by the rural Indian migrants in the megacities post-lockdown has initiated one of the largest exodus of people back into the rural areas. Meanwhile, in the Western Pacific Region, the International Olympic Committee (IOC) postpones the Tokyo Summer Olympics to July 23rd, 2021 to August 8th, 2021. Online debates also continued to swirl around the degree of China’s influence on the WHO. On Sunday, Taiwan’s Foreign Minister Joseph Wu tweeted a complaint referring a senior WHO official’s response to a question from a Hong Kong journalist, about whether WHO would reconsider Taiwan application for member state status. “Wow, can’t even utter ‘Taiwan’ in the WHO? You should set politics aside in dealing with a pandemic,” Wu wrote. Taiwan has accused WHO of ignoring its early warnings about the appearance of a novel coronavirus in mainland China, as well as brushing aside subsequent criticism that China repressed early news about the virus spread, which delayed a more systematic public health response. Overall, Europe continued to lead with half or more of the now active COVID-19 cases worldwide, followed by the United States. There were some 30,000 active cases in the Eastern Mediterranean Region, including heavily hit Iran. South-East Asia was reporting nearly 3,600 active cases, and in WHO’s Africa region, there were more than 3,300 infections reported. In the Western Pacific Region, there were some 18,095 active cases, but only about 3,000 of those were in mainland China. Total cases of COVID-19 as of 8 p.m CET, with active case distribution globally. Numbers change rapidly. -Tsering Lhamo contributed to this report. Image Credits: WHO EMRO. Blood Plasma Of Recovered COVID-19 Patients Approved By US FDA For Investigational Use As Treatment 25/03/2020 Grace Ren Technician separates blood components into plasma, platelets, and red blood cells. The US Food and Drug Administration granted investigational emergency use approval for convalescent blood plasma as a potential COVID-19 treatment on Tuesday. Cloned antibodies from recovered COVID-19 patients showed impressive ability to neutralize SARS-CoV-2, the virus behind the disease, in cell cultures, according to a paper published Wednesday on the preprint server BioRxiv. Two of the most potent antibodies isolated, 299 P2C-1F11 and P2B-2F6, were able to bind so strongly to the virus that it reduced the percentage of virus attaching to live cells by almost 100%. Patients who have recovered from COVID-19 have antibodies in their blood that might be effective against the infection. These antibodies, found in the blood plasma – or the transparent, liquid part of the blood – could be then injected into COVID-19 patients to provide some immunity as the host immune system ramps up its own response. Early evidence from a Chinese trial in 10 patients showed “significant improvement” within 1 to 3 days after receiving a blood plasma transfusion, with 2 of the 3 patients weaned off mechanical ventilation shortly after the transfusion. New York State, which has about half of the 62,873 COVID-19 cases in the United States, is set to roll-out the first treatments within the next week, Governor Andrew Cuomo said on Monday. According to CNN, New York will be first recruiting recovered patients from New Rochelle, which saw the first cluster of cases in the state and thus has the largest cluster of recovered COVID-19 patients eligible to donate blood. Although promising, convalescent blood plasma is not effective for every disease, says the US FDA, including for viral diseases such as Ebola. Success in cell culture studies must still be replicated in human patients. However, experts have been pushing since January for more serious consideration of such treatment as a potential COVID-19 treatment, based on limited success in treating other coronaviruses, such as SARS and MERS. Under US FDA regulations, the treatment is only available to patients with a lab confirmed positive COVID-19 test experiencing severe disease, and enrolled in a clinical trial. A recovered patient with a prior lab-confirmed COVID19 diagnosis may donate blood plasma 2 weeks after their symptoms resolve, and only if they then test negative for COVID-19. The collected blood plasma can then be immediately infused into COVID-19 patients with severe disease, after the donation is screened for other blood-borne diseases. Other trials of blood plasma or plasma-derived products are already taking place at the University of Washington in St. Louis, Missouri. Scientists there submitted a investigational new drug application to the FDA on 18 March. In a related development, the pharma firm Takeda announced on 4 March that the company initiated development of an antibody treatment derived from plasma. 61 Organizations Call On EU To Ensure Accessibility of New Coronavirus Products Some 61 NGOs released an open letter on Wednesday calling on the European Union and national governments to incorporate access and affordability products into approvals for new COVID-19 products. The groups also said that governments should exclusive licensing, and require disclosure of public contributions to drug development as part of COVID-19 research. “In the current pandemic situation when time is of the essence and it is critical that any treatment developed with public funds is made as widely available as possible, the call for greater transparency and accountability for public funds used in biomedical R&D is particularly pertinent,” said Jaume Vidal, senior policy advisor at Health Action International, the access organization that coordinated the letter, in an interview with Health Policy Watch. Vidal added that making COVID-19 drugs as widely available as possible “necessarily entails” affordability requirements, and that the ask on non-exclusive licensing was a “specific demand to counter” medicines shortages, which can be caused by limiting the number of producers. A recent fast-track US $45 million call for proposals on developing therapeutics and diagnostics for COVID-19 by the Innovative Medicine Initiative (IMI) did not require affordability clauses, according to the letter. Affordability clauses help ensure that any successful products developed by grant money are not priced out of reach of low- or middle-income countries, or poorer health systems. Additionally, the NGOs said that granting exclusive licenses for successful COVID-19 product should not be allowed, just days after the US FDA granted Gilead’s remdesivir, a promising coronavirus antiviral, “orphan drug” status – giving the pharma company 7 years of US market exclusivity. However in an unusual about-face, the company requested the FDA rescind the “orphan drug” designation on Wednesday after facing a public backlash from medicines access advocates. The open letter said that market exclusivity on COVID-19 products could create “excessively high prices or over-reliance on a single source, which can increase the possibility of shortages. “An effective response requires that all these necessary medical tools are free of charge at the point of delivery, particularly for vulnerable populations,” the organizations stated in the letter. Europe Remains the Epicentre, But Some Countries Can Still Stem the Tide. The letter was released as active cases in Europe surged to 197,842 cases and 12,822 total deaths. Italy and Spain remain the worst affected countries with 54,030 and 40,382 active cases respectively; however, Switzerland with 9765 cases has now overtaken Italy to have the highest number of cases per capita. In Italy, fatalities rose to 743 deaths, after several days of lower numbers. Prime Minister Giuseppe Conte increased fines for leaving homes to up to 3,000 euros from the previous maximum of 206 euros. In Spain, an ice rink in Madrid has been converted into a temporary morgue, according to El Paiz. Meanwhile, across the Atlantic, cases shot up in the United States to 62,873, with 30,811 alone in New York State. The uptick of cases in the state is also driven by increased testing. The state is testing more than 16,000 people a day, a higher per capita testing rate than even China or South Korea, according to a press release from Governor Andrew Cuomo’s office. However, other states in the US are still facing test kit shortages – amid mixed messages from the White House on whether most US workers will be able to return to their jobs again by Easter. In Latin America, Brazil remains the most affected country at 2155 cases followed by Chile with 903 and Ecuador with 775 cases. As the number of cases escalates in Chile, the government is facing pressure to introduce a national lockdown, following in Argentina’s footsteps, according to National Public Radio. Chilean President Sebastian Piñera has declared the situation as “a state of catastrophe” and has deployed the armed forces to maintain infrastructure and supply lines. According to the latest WHO situation report, the total number of cases in the WHO African Region is 1305 -315 more than the previous day – and deaths increased from 23 to 26. South Africa, Algeria and Burkina Faso are the most affected countries in the region with 402, 231 and 99 cases respectively. President of the Democratic Republic of the Congo Felix Tshisekedi declared a “state of emergency” Wednesday morning as the case count hit 45 cases and 3 deaths, closing country borders and banning all flights, even domestic ones, from entering Kinshasa, in an attempt to lock down the country’s dense urban center. However, according to World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, around the world more than 150 countries still have less than 100 cases – and those nations still had a chance to prevent widespread disruptions from COVID-19. “Aggressive measures to find, isolate, test, treat and trace are not only the best and fastest way out of extreme social and economic restrictions – they’re also the best way to prevent them,” said Dr Tedros. Active cases around the world as of 11PM CET 25 March. Right column shows cumulative case count. Numbers are rapidly changing. This story was updated 27 March 2020. Image Credits: Banc de Sang i Teixits, Johns Hopkins CSSE. Médecins Sans Frontières Announces Campaign For $5 COVID-19 Test On ‘GeneXpert’ TB Platform 24/03/2020 Grace Ren Healthcare worker runs a test on a GeneXpert machine. Médecins Sans Frontiéres (MSF) on Tuesday launched a campaign to push for a US $5 price tag on a new COVID-19 rapid diagnostic test that can be used on GeneXpert, a diagnostic instrument widely deployed around the world for diagnosing tuberculosis. The test for SARS-CoV-2, the virus that causes COVID-19, received US Food and Drug Administration emergency use approval just last Friday, and represents a hope for scaling up COVID-19 testing in low- and middle-income countries. The MSF announcement coincided with World Tuberculosis Day, and reflected one of the many ways in which the battle against one of the world’s oldest respiratory diseases, TB and the battle against the newest threat to lung health from COVID-19, are now converging. “The Xpert Xpress SARS-CoV-2 Test for testing for the novel coronavirus should be no more than $5 a cartridge,” said Sharonann Lynch, HIV and TB Policy Advisor at Médecins Sans Frontiéres/Doctors Without Borders’ Access Campaign, in an interview with Health Policy Watch. The US company that produces GeneXpert tests Cepheid has set the coronavirus test price at $19.80 per cartridge for 145 developing countries, according to Lynch. In high income countries, the coronavirus test will cost $35 per cartridge. The TB test for the platform currently costs $9.98 per cartridge for low- and middle- income countries. An HIV diagnostic test, which can also be performed on the platform, costs $14 per cartridge. However, even the US $10 price on the TB test is too high for many countries, said Lynch. Thus, Cepheid could “drastically lower the price to $5 per test.” An assessment of other GeneXpert tests by MSF and Cambridge Consultants found that a US $5 price tag per cartridge could still generate profit for Cepheid, as the ‘cost of goods’ – or the cost of materials, manufacturing, labour, overhead, intellectual property, and other indirect expenses – is estimated to be only US $3. The campaign for a $US 5 coronavirus test is an extension of an existing ‘Time for 5’ campaign by MSF to knock down prices for TB and HIV test cartridges to US $5 a piece. WHO Releases New Guidelines For Preventative TB Treatment Also on World Tuberculosis Day, the World Health Organization released new guidelines to scale up new, and dramatically shorter preventative regimens for latent tuberculosis (TB), one of mankind’s oldest and deadliest diseases. “COVID-19 is highlighting just how vulnerable people with lung diseases and weakened immune systems can be,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Millions of people need to be able to take TB preventative treatment to stop the onset of disease, avert suffering, and save lives.” In the context of the COVID-19 pandemic, “early evidence suggests that people with TB will be more susceptible to coronavirus and severe COVID-19,” said Lynch. Thus, scaling up preventative TB treatment could also help reduce negative impacts of the rapidly accelerating COVID-19 pandemic according to the WHO, which has also released guidance on how to sustain TB treatment during the COVID-19 emergency. Tuberculosis remains the world’s top infectious killer – in 2018 there were an estimated 10 million new symptomatic infections and 1.5 million deaths. About a quarter of the world’s population is estimated to be infected with TB bacteria, but are not sick nor contagious. However, those with such “latent” TB are at higher risk of developing active disease, which can be particularly deadly in immunocompromised people. Treating latent TB remains the most effective strategy to prevent the progression to active disease and protect others against onwards transmission – but has been largely neglected as a part of TB control programmes. To date, only 430,000 of the target 24 million contacts of people with active TB and only 1.8 million of the target 6 million people living with HIV have received preventative treatment. The new WHO guidelines recommend new shorter regimens for preventative treatment for latent forms of the disease, ranging from a 1 month daily rifapentine/isoniazid treatment to 4 months of daily rifampicin alone – shaving off months from the previous standard 6-month isoniazid treatment. The guidelines also recommend the rapid scale-up of preventative TB treatment among populations at highest risk, including household contacts of TB patients, people living with HIV, and those with lowered immunity or living in crowded settings; integrating TB preventative treatment into case-finding efforts for active TB, and using tuberculin skin tests or an interferon-gamma release assay (IGRA) to test for infection when tests are available. Woman puts on a facemask at a healthcare facility for drug-resistant TB patients in New Delhi, India Leveraging TB Knowledge To Fight COVID-19 As the COVID-19 pandemic accelerates, the World Health Organization and leading TB organizations also are promoting a joint approach to tackling both the world’s oldest and newest respiratory threats. New WHO guidance for TB programme directors recommends leveraging TB prevention strategies, technologies and logistics, and programmatic staff to tackle the diseases. TB staff, with years of experience in low-resource settings, are well positioned to offer technical assistance in contact tracing and active case finding, the cornerstones of a robust COVID-19 response. “We know what works to fight COVID-19 from our experience and the tools we have developed to end TB: infection control, wide-spread testing, contact tracing, X-rays, artificial intelligence, telemedicine and psycho-social support,” said José Luis Castro, executive director of The International Union Against TB and Lung Diseases (The Union) in a press release. However, some TB advocates have also expressed concerns that the global focus on COVID-19 could shift resources from essential TB treatment services. “The COVID emergency should marshall all necessary resources, but not at the expense of TB services, including TB testing, or people with TB,” said Lynch. Additionally, with countries enacting more strict travel restrictions in the face of accelerating COVID-19 outbreaks, it may be time to try a new model of care for TB patients For those with active TB, a full treatment course is at least 6 months and treatment is usually directly observed by providers, which means patients or healthcare workers must travel daily to meet in clinics or homes to administer treatment. “To reduce the risk for existing patients, [we] must seek ways to re-design models of care to provide treatment for people with TB in the community and use remote telemedicine and web apps to support them,” Lynch suggested. Image Credits: WHO/UNITAID, CNS Images. As Coronavirus Spreads, It’s Time To Diagnose & Treat Our Broken Primary Health Care Systems 24/03/2020 Dan Schwarz & Beth Tritter Staff members administering vaccinations at Kabuga Health Center in the Gasabo district of Kigali (Rusororo sector), Rwanda on June 28, 2018. As the explosive impact of COVID-19 ripples globally, there’s a clear plea from many regions and countries: stay home and help “flatten the curve” of infection. People from China to Italy have seen the consequences of the virus spreading too quickly with hospitals overwhelmed and doctors forced to make heartbreaking decisions about who lives and dies. It’s natural to hear these stories and blame a lack of pandemic preparedness. But emergency response can only go so far if the health system’s first line of defense – primary health care – isn’t up to the task. Experts have already called attention to gaps in front line health supplies, such as masks, hand sanitizer, testing kits and vaccines. In the U.S., where we live, these gaps mean we’re now fighting a steep uphill battle in containing the virus. But few are talking about shortcomings of the primary health care system, which is about far more than just supplies. Strong primary health care looks like a trusted nurse or doctor, who is always there and trained to answer your questions. It means comprehensive quality care – in one place – tailored to your health needs. It means confidence that your local health center is safe and ready with quality medicines and supplies, regardless of outbreaks or changes in the world around you. Whether or not a crisis is looming, primary health care should be the first place everyone turns for health services or information, using hospitals only when truly necessary. For most people worldwide, though, access to quality primary health care depends on where you live or how much money you have. In fact, primary health care is chronically underfunded and deprioritized in rich and poor countries alike. COVID-19 has made it painfully clear that we can’t afford to have weak primary health care continue as our reality. In the U.S., fragmented care and lack of clear communication from experts has left people anxious about where to turn, making unnecessary visits to emergency rooms. In Italy, where the health care system has experienced cuts in funding over the past decade, we’re seeing the dire consequences of having too few staff and supplies. And across Africa, where the virus is rapidly spreading, misinformation and mistrust of health systems could keep people from seeking care – as we saw in Liberia and other West African countries during the 2014-2016 Ebola outbreak. This doesn’t have to be the case. There are clear steps the world can take to fully unlock the potential of primary health care, both to help us respond to the current pandemic and prepare for disease outbreaks we’ll inevitably face in the future. In the short-term, primary care providers should be considered central partners and first responders in this crisis, helping to test and triage the most at-risk patients, and reducing the burden on already-overwhelmed hospitals. Leaders owe them reliable information and tools, including additional support for logistics and staffing and critical supplies such as rapid test kits and personal protective equipment. Such approaches have paid off in a big way in countries like Singapore, where they’ve been able to mobilize a trusted and well-resourced primary health care workforce. Trusted primary care providers can also play a key role disseminating prevention messages to the public and high-risk groups, and encouraging social distancing by offering telehealth services for people with COVID-19 symptoms and chronic disease patients alike. In the weeks and months ahead, countries and donors should also resist the urge to earmark all response funds for coronavirus-specific care. As health systems approach breaking point, flexible funds for primary health care can aid the response and prevent disruptions to essential daily life-saving services, from delivering babies to treating chronic conditions. This approach will also help head off future epidemics, rather than promote a continuous cycle of “Band-Aid” investments that ignore the root of the problem. In the long term, governments must significantly increase spending on quality primary health care to make sure it’s well-resourced and affordable – so that no one has to choose between seeking care and paying their bills. The World Health Organization estimates that it will take an additional $200 billion annually to fund quality primary health care for all; well-spent, this could save 60 million lives in low- and middle-income countries alone. Finally, we can’t fix problems that we can’t diagnose. Countries desperately need better ways to take the temperature of their primary health care systems. At the Primary Health Care Performance Initiative, a partnership of country policymakers, health systems managers and advocates, we’re working with governments around the world to collect more and better data, equipping leaders to pinpoint weaknesses and improve health systems before the next pandemic hits. Counting treatments or people infected is not enough – we need to know if people trust and value their care; if health workers are trained, resourced and motivated; and if clinics are safe, clean and well-managed. We are only as prepared as the world’s weakest health system. The world has repeatedly failed to learn this before. We must do better beginning today, or this won’t be the last time we pay the price. ______________________________________________________________________________ Dan Schwarz, MD MPH is the Director of Primary Health Care at Ariadne Labs and an Adviser to the WHO and the Lancet Commission on Noncommunicable Diseases and Poverty, with over a decade of experience in global healthcare delivery. Beth Tritter is the Executive Director of the Primary Health Care Performance Initiative (PHCPI). PHCPI was founded in 2015 by the Bill & Melinda Gates Foundation, the World Health Organization and the World Bank Group, and now including UNICEF, in collaboration with Ariadne Labs and Results for Development. She previously served in the U.S. government as the Millennium Challenge Corporation’s Vice President for Policy and Evaluation. Image Credits: Bill & Melinda Gates Foundation/Samantha Reinders. WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WHO Nears $675 Million ‘Goal’ For COVID-19 Response – $622 Million Pledged 30/03/2020 Grace Ren & Svĕt Lustig Vijay WHO team of technical experts conclude a COVID-19 support mission to Egypt. The World Health Organization has received more than US $622 million of a US $675 million ask to fund WHO’s first Strategic Preparedness and Response Plan for COVID-19, WHO Director-General Dr Tedros Adhanom Ghebreyesus said on Monday. “We continue to be encouraged by the signs of global solidarity to confront and overcome this common threat,” said Dr Tedros, speaking at an afternoon press briefing. In a parallel development, Norway is leading an initiative to establish a multi-donor fund for the global COVID-19 response to assist developing countries, coordinating with the United Nations to launch the initiative within the next few days. “A multi-donor fund under UN auspices will provide predictability for our partners and help to make the efforts more effective,” said Minister of Foreign Affairs Ine Eriksen Søreide in a press release. ‘Experience from other crises shows that the earlier you start long-term response planning, the more precise and successful the effort becomes.” Unlike the UN Solidarity Fund, which is soliciting donations from individuals and private donors for the response, this fund will collate resources from major bilateral donors and international agencies, similar to the UN Ebola Response Fund set up in 2014 to address the emergency in West Africa. The fund will provide both immediate emergency aid to developing countries, and aid for longer term development initiatives to prop up weak health systems to prepare for future pandemics. In another meeting Monday with Ministers of Trade from the Group of 20 (G20) richest countries in the world, Dr Tedros also called on G20 countries to significantly their increase production of personal protective equipment (PPE), and ensure its equitable distribution of equipment around the world. “Specific attention should be given to low- and middle-income countries in Africa, Asia and Latin America,” said Dr Tedros in a statement. “We call on countries to work with companies to increase production; to ensure the free movement of essential health products; and to ensure equitable distribution of those products, based on need.” However, hoarding and misappropriation of donated PPE equipment also may loom as a thorny problems that donors need to resolve. At the China-Uganda Friendship Referral Hospital near Kampala, one of three Ugandan reference hospitals for COVID-19 cases, health workers taking throat swabs from suspected COVID-19 patients and managing an isolation ward, lack basic protective gear except gloves, Health Policy Watch learned. N-95 masks must be purchased by the doctors and nurses out of pocket, and protective gowns and face shields are unavavilable. Gloves were provided by the hospital after workers threatened to strike, but when supplies run low, patients have to pay for those themselves before they are examined. WHO did not comment on the report. 154 NGOs Submit Open Letter Calling For Gilead To Retract Remdesivir Patent Applications Some 154 NGOs released an open letter Monday calling for Gilead Sciences to rescind its patent applications for remdesivir in 70 countries that could grant the company market exclusivity until 2031 on the experiemental drug, a promising potential COVID-19 treatment. The campaign, coordinated by Médecins Sans Frontières (MSF), aligns closely with a growing movement within the medicines access community to push for mandatory “pooled” rights for COVID-19 technologies. In an unusual move, Gilead already asked the US FDA to rescind special “orphan drug” status for remdesivir last week after facing an intense public backlash, just days after recieving the designation. Orphan drug status would have granted Gilead an addition 7 years of market exclusivity. However, according to the MSF statement, the company still has pending patent applications for remdesivir in at least 70 other countries. “It is unacceptable for Gilead’s remdesivir to be put under the company’s exclusive control, taking into account that the drug was developed with considerable public funding for both early-stage research and clinical trials; the extraordinary efforts and personal risks that both healthcare workers and patients have faced in using the medicine in clinical trial settings; and the unprecedented disaster all countries are facing for their people, their healthcare systems, and their economies” said Medecins Sans Frontieres (MSF) in a statement today. In the open letter, Gilead was urged to take immediate action in the public interest by declaring that it will drop all exclusive rights on patents, regulatory and trial data, as well as making all data required for development of generic drug versions publically available to enable their production and supply. Finally, Gilead was requested to improve its transparency by disclosing its existing supply and manufacturing capacity. “There is a further step to take, as a voluntary pool may not be sufficient, especially when the crisis intensity cools and public approbation for actions like Gilead’s Orphan designation abates,” said Paul Fehlner, President & CEO of reVision Therapeutics, in an interview with Health Policy Watch. “An entity dedicated to the public interest could obtain consequential legal exclusivities (Orphan drug designation, data and market exclusivity) and prevent opportunistic third parties from getting them”. According to Fehlner, creating a “pool” of rights would take minimum efforts, only requiring a willing coordinator to “aggregate data from ongoing trials worldwide and submit formal applications to health authorities.” “This crisis presents an immediate and urgent opportunity to wield the tools of exclusivity to promote access to medical products that may combat COVID-19,” said Fehlner. COVID-19 Trends As the United States now leads the world in coronavirus cases with 143,055 confirmed cases and 2,513 deaths according to the Johns Hopkins tracking database, President Trump extended the U.S. social distancing guidelines until the end of April, rescinding his earlier predictions that the lockdown would end by mid-April’s Easter holiday. Meanwhile, the UN donated 250,000 protective face masks to the USA from its New York headquarters to help combat the outbreak’s epicenter in New York. As the US is faced with rapidly increasing cases, inefficiencies from failed coronavirus tests, and shortage of ventilators, STATNews reports that the Genomics Institute led by Jennifer Doudna, the pioneer of CRISPR gene editing technology, will start running coronavirus tests in order to increase the turnaround time of testings in the San Francisco Bay Area. Over the weekend, Italy and Spain bolster efforts to curb the spread of the coronavirus and flatten the curve. Italy, numbers 97,689 cases and 10,779 deaths, and Spain, numbers 85,195 cases and 7,340 deaths, have overtaken China’s 82,198 cases and 3,308 deaths according to the Johns Hopkins coronavirus tracking database. As infection increases, Italy has decided to extend its national lockdown beyond the April 3rd date while Spain tightens the national lockdown for all citizens, except for the workers in the essential sectors until April 9th. As the rate of infection within countries intensified, European countries began to depart from longstanding WHO guidance against the wearing of masks by the general public. Notably, Austria made masks obligatory for clients in supermarkets mandatory to curb airborne spread of the coronavirus amongst customers. Crowded supermarkets have been identified in a number of countries as nexus points for virus spread. However, until now, universal masking has only been practiced in Asia, while WHO repeatedly said the measure was unecessary elsewhere. The Hungarian Parliament, meanwhile, awarded wide-ranging powers to Prime Minister Viktor Orban for an indefinite period, to fight the pandemic, including curtailing free speech and other democratic rights. South-East and Western Asia In South-East Asia, the coronavirus was increasingly disrupting the lives of those living on the socioeconomic margins. After Prime Minister Modi’s surprise lockdown announcement, India’s daily wage earners struggle under the nationwide lockdown as many are stranded in cities without food, housing, and means of getting back home, particularly vulnerable are the Muslim minority who have been victims of recent riots over amendments to the naional citizenship bill. The challenges faced by the rural Indian migrants in the megacities post-lockdown has initiated one of the largest exodus of people back into the rural areas. Meanwhile, in the Western Pacific Region, the International Olympic Committee (IOC) postpones the Tokyo Summer Olympics to July 23rd, 2021 to August 8th, 2021. Online debates also continued to swirl around the degree of China’s influence on the WHO. On Sunday, Taiwan’s Foreign Minister Joseph Wu tweeted a complaint referring a senior WHO official’s response to a question from a Hong Kong journalist, about whether WHO would reconsider Taiwan application for member state status. “Wow, can’t even utter ‘Taiwan’ in the WHO? You should set politics aside in dealing with a pandemic,” Wu wrote. Taiwan has accused WHO of ignoring its early warnings about the appearance of a novel coronavirus in mainland China, as well as brushing aside subsequent criticism that China repressed early news about the virus spread, which delayed a more systematic public health response. Overall, Europe continued to lead with half or more of the now active COVID-19 cases worldwide, followed by the United States. There were some 30,000 active cases in the Eastern Mediterranean Region, including heavily hit Iran. South-East Asia was reporting nearly 3,600 active cases, and in WHO’s Africa region, there were more than 3,300 infections reported. In the Western Pacific Region, there were some 18,095 active cases, but only about 3,000 of those were in mainland China. Total cases of COVID-19 as of 8 p.m CET, with active case distribution globally. Numbers change rapidly. -Tsering Lhamo contributed to this report. Image Credits: WHO EMRO. Blood Plasma Of Recovered COVID-19 Patients Approved By US FDA For Investigational Use As Treatment 25/03/2020 Grace Ren Technician separates blood components into plasma, platelets, and red blood cells. The US Food and Drug Administration granted investigational emergency use approval for convalescent blood plasma as a potential COVID-19 treatment on Tuesday. Cloned antibodies from recovered COVID-19 patients showed impressive ability to neutralize SARS-CoV-2, the virus behind the disease, in cell cultures, according to a paper published Wednesday on the preprint server BioRxiv. Two of the most potent antibodies isolated, 299 P2C-1F11 and P2B-2F6, were able to bind so strongly to the virus that it reduced the percentage of virus attaching to live cells by almost 100%. Patients who have recovered from COVID-19 have antibodies in their blood that might be effective against the infection. These antibodies, found in the blood plasma – or the transparent, liquid part of the blood – could be then injected into COVID-19 patients to provide some immunity as the host immune system ramps up its own response. Early evidence from a Chinese trial in 10 patients showed “significant improvement” within 1 to 3 days after receiving a blood plasma transfusion, with 2 of the 3 patients weaned off mechanical ventilation shortly after the transfusion. New York State, which has about half of the 62,873 COVID-19 cases in the United States, is set to roll-out the first treatments within the next week, Governor Andrew Cuomo said on Monday. According to CNN, New York will be first recruiting recovered patients from New Rochelle, which saw the first cluster of cases in the state and thus has the largest cluster of recovered COVID-19 patients eligible to donate blood. Although promising, convalescent blood plasma is not effective for every disease, says the US FDA, including for viral diseases such as Ebola. Success in cell culture studies must still be replicated in human patients. However, experts have been pushing since January for more serious consideration of such treatment as a potential COVID-19 treatment, based on limited success in treating other coronaviruses, such as SARS and MERS. Under US FDA regulations, the treatment is only available to patients with a lab confirmed positive COVID-19 test experiencing severe disease, and enrolled in a clinical trial. A recovered patient with a prior lab-confirmed COVID19 diagnosis may donate blood plasma 2 weeks after their symptoms resolve, and only if they then test negative for COVID-19. The collected blood plasma can then be immediately infused into COVID-19 patients with severe disease, after the donation is screened for other blood-borne diseases. Other trials of blood plasma or plasma-derived products are already taking place at the University of Washington in St. Louis, Missouri. Scientists there submitted a investigational new drug application to the FDA on 18 March. In a related development, the pharma firm Takeda announced on 4 March that the company initiated development of an antibody treatment derived from plasma. 61 Organizations Call On EU To Ensure Accessibility of New Coronavirus Products Some 61 NGOs released an open letter on Wednesday calling on the European Union and national governments to incorporate access and affordability products into approvals for new COVID-19 products. The groups also said that governments should exclusive licensing, and require disclosure of public contributions to drug development as part of COVID-19 research. “In the current pandemic situation when time is of the essence and it is critical that any treatment developed with public funds is made as widely available as possible, the call for greater transparency and accountability for public funds used in biomedical R&D is particularly pertinent,” said Jaume Vidal, senior policy advisor at Health Action International, the access organization that coordinated the letter, in an interview with Health Policy Watch. Vidal added that making COVID-19 drugs as widely available as possible “necessarily entails” affordability requirements, and that the ask on non-exclusive licensing was a “specific demand to counter” medicines shortages, which can be caused by limiting the number of producers. A recent fast-track US $45 million call for proposals on developing therapeutics and diagnostics for COVID-19 by the Innovative Medicine Initiative (IMI) did not require affordability clauses, according to the letter. Affordability clauses help ensure that any successful products developed by grant money are not priced out of reach of low- or middle-income countries, or poorer health systems. Additionally, the NGOs said that granting exclusive licenses for successful COVID-19 product should not be allowed, just days after the US FDA granted Gilead’s remdesivir, a promising coronavirus antiviral, “orphan drug” status – giving the pharma company 7 years of US market exclusivity. However in an unusual about-face, the company requested the FDA rescind the “orphan drug” designation on Wednesday after facing a public backlash from medicines access advocates. The open letter said that market exclusivity on COVID-19 products could create “excessively high prices or over-reliance on a single source, which can increase the possibility of shortages. “An effective response requires that all these necessary medical tools are free of charge at the point of delivery, particularly for vulnerable populations,” the organizations stated in the letter. Europe Remains the Epicentre, But Some Countries Can Still Stem the Tide. The letter was released as active cases in Europe surged to 197,842 cases and 12,822 total deaths. Italy and Spain remain the worst affected countries with 54,030 and 40,382 active cases respectively; however, Switzerland with 9765 cases has now overtaken Italy to have the highest number of cases per capita. In Italy, fatalities rose to 743 deaths, after several days of lower numbers. Prime Minister Giuseppe Conte increased fines for leaving homes to up to 3,000 euros from the previous maximum of 206 euros. In Spain, an ice rink in Madrid has been converted into a temporary morgue, according to El Paiz. Meanwhile, across the Atlantic, cases shot up in the United States to 62,873, with 30,811 alone in New York State. The uptick of cases in the state is also driven by increased testing. The state is testing more than 16,000 people a day, a higher per capita testing rate than even China or South Korea, according to a press release from Governor Andrew Cuomo’s office. However, other states in the US are still facing test kit shortages – amid mixed messages from the White House on whether most US workers will be able to return to their jobs again by Easter. In Latin America, Brazil remains the most affected country at 2155 cases followed by Chile with 903 and Ecuador with 775 cases. As the number of cases escalates in Chile, the government is facing pressure to introduce a national lockdown, following in Argentina’s footsteps, according to National Public Radio. Chilean President Sebastian Piñera has declared the situation as “a state of catastrophe” and has deployed the armed forces to maintain infrastructure and supply lines. According to the latest WHO situation report, the total number of cases in the WHO African Region is 1305 -315 more than the previous day – and deaths increased from 23 to 26. South Africa, Algeria and Burkina Faso are the most affected countries in the region with 402, 231 and 99 cases respectively. President of the Democratic Republic of the Congo Felix Tshisekedi declared a “state of emergency” Wednesday morning as the case count hit 45 cases and 3 deaths, closing country borders and banning all flights, even domestic ones, from entering Kinshasa, in an attempt to lock down the country’s dense urban center. However, according to World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, around the world more than 150 countries still have less than 100 cases – and those nations still had a chance to prevent widespread disruptions from COVID-19. “Aggressive measures to find, isolate, test, treat and trace are not only the best and fastest way out of extreme social and economic restrictions – they’re also the best way to prevent them,” said Dr Tedros. Active cases around the world as of 11PM CET 25 March. Right column shows cumulative case count. Numbers are rapidly changing. This story was updated 27 March 2020. Image Credits: Banc de Sang i Teixits, Johns Hopkins CSSE. Médecins Sans Frontières Announces Campaign For $5 COVID-19 Test On ‘GeneXpert’ TB Platform 24/03/2020 Grace Ren Healthcare worker runs a test on a GeneXpert machine. Médecins Sans Frontiéres (MSF) on Tuesday launched a campaign to push for a US $5 price tag on a new COVID-19 rapid diagnostic test that can be used on GeneXpert, a diagnostic instrument widely deployed around the world for diagnosing tuberculosis. The test for SARS-CoV-2, the virus that causes COVID-19, received US Food and Drug Administration emergency use approval just last Friday, and represents a hope for scaling up COVID-19 testing in low- and middle-income countries. The MSF announcement coincided with World Tuberculosis Day, and reflected one of the many ways in which the battle against one of the world’s oldest respiratory diseases, TB and the battle against the newest threat to lung health from COVID-19, are now converging. “The Xpert Xpress SARS-CoV-2 Test for testing for the novel coronavirus should be no more than $5 a cartridge,” said Sharonann Lynch, HIV and TB Policy Advisor at Médecins Sans Frontiéres/Doctors Without Borders’ Access Campaign, in an interview with Health Policy Watch. The US company that produces GeneXpert tests Cepheid has set the coronavirus test price at $19.80 per cartridge for 145 developing countries, according to Lynch. In high income countries, the coronavirus test will cost $35 per cartridge. The TB test for the platform currently costs $9.98 per cartridge for low- and middle- income countries. An HIV diagnostic test, which can also be performed on the platform, costs $14 per cartridge. However, even the US $10 price on the TB test is too high for many countries, said Lynch. Thus, Cepheid could “drastically lower the price to $5 per test.” An assessment of other GeneXpert tests by MSF and Cambridge Consultants found that a US $5 price tag per cartridge could still generate profit for Cepheid, as the ‘cost of goods’ – or the cost of materials, manufacturing, labour, overhead, intellectual property, and other indirect expenses – is estimated to be only US $3. The campaign for a $US 5 coronavirus test is an extension of an existing ‘Time for 5’ campaign by MSF to knock down prices for TB and HIV test cartridges to US $5 a piece. WHO Releases New Guidelines For Preventative TB Treatment Also on World Tuberculosis Day, the World Health Organization released new guidelines to scale up new, and dramatically shorter preventative regimens for latent tuberculosis (TB), one of mankind’s oldest and deadliest diseases. “COVID-19 is highlighting just how vulnerable people with lung diseases and weakened immune systems can be,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Millions of people need to be able to take TB preventative treatment to stop the onset of disease, avert suffering, and save lives.” In the context of the COVID-19 pandemic, “early evidence suggests that people with TB will be more susceptible to coronavirus and severe COVID-19,” said Lynch. Thus, scaling up preventative TB treatment could also help reduce negative impacts of the rapidly accelerating COVID-19 pandemic according to the WHO, which has also released guidance on how to sustain TB treatment during the COVID-19 emergency. Tuberculosis remains the world’s top infectious killer – in 2018 there were an estimated 10 million new symptomatic infections and 1.5 million deaths. About a quarter of the world’s population is estimated to be infected with TB bacteria, but are not sick nor contagious. However, those with such “latent” TB are at higher risk of developing active disease, which can be particularly deadly in immunocompromised people. Treating latent TB remains the most effective strategy to prevent the progression to active disease and protect others against onwards transmission – but has been largely neglected as a part of TB control programmes. To date, only 430,000 of the target 24 million contacts of people with active TB and only 1.8 million of the target 6 million people living with HIV have received preventative treatment. The new WHO guidelines recommend new shorter regimens for preventative treatment for latent forms of the disease, ranging from a 1 month daily rifapentine/isoniazid treatment to 4 months of daily rifampicin alone – shaving off months from the previous standard 6-month isoniazid treatment. The guidelines also recommend the rapid scale-up of preventative TB treatment among populations at highest risk, including household contacts of TB patients, people living with HIV, and those with lowered immunity or living in crowded settings; integrating TB preventative treatment into case-finding efforts for active TB, and using tuberculin skin tests or an interferon-gamma release assay (IGRA) to test for infection when tests are available. Woman puts on a facemask at a healthcare facility for drug-resistant TB patients in New Delhi, India Leveraging TB Knowledge To Fight COVID-19 As the COVID-19 pandemic accelerates, the World Health Organization and leading TB organizations also are promoting a joint approach to tackling both the world’s oldest and newest respiratory threats. New WHO guidance for TB programme directors recommends leveraging TB prevention strategies, technologies and logistics, and programmatic staff to tackle the diseases. TB staff, with years of experience in low-resource settings, are well positioned to offer technical assistance in contact tracing and active case finding, the cornerstones of a robust COVID-19 response. “We know what works to fight COVID-19 from our experience and the tools we have developed to end TB: infection control, wide-spread testing, contact tracing, X-rays, artificial intelligence, telemedicine and psycho-social support,” said José Luis Castro, executive director of The International Union Against TB and Lung Diseases (The Union) in a press release. However, some TB advocates have also expressed concerns that the global focus on COVID-19 could shift resources from essential TB treatment services. “The COVID emergency should marshall all necessary resources, but not at the expense of TB services, including TB testing, or people with TB,” said Lynch. Additionally, with countries enacting more strict travel restrictions in the face of accelerating COVID-19 outbreaks, it may be time to try a new model of care for TB patients For those with active TB, a full treatment course is at least 6 months and treatment is usually directly observed by providers, which means patients or healthcare workers must travel daily to meet in clinics or homes to administer treatment. “To reduce the risk for existing patients, [we] must seek ways to re-design models of care to provide treatment for people with TB in the community and use remote telemedicine and web apps to support them,” Lynch suggested. Image Credits: WHO/UNITAID, CNS Images. As Coronavirus Spreads, It’s Time To Diagnose & Treat Our Broken Primary Health Care Systems 24/03/2020 Dan Schwarz & Beth Tritter Staff members administering vaccinations at Kabuga Health Center in the Gasabo district of Kigali (Rusororo sector), Rwanda on June 28, 2018. As the explosive impact of COVID-19 ripples globally, there’s a clear plea from many regions and countries: stay home and help “flatten the curve” of infection. People from China to Italy have seen the consequences of the virus spreading too quickly with hospitals overwhelmed and doctors forced to make heartbreaking decisions about who lives and dies. It’s natural to hear these stories and blame a lack of pandemic preparedness. But emergency response can only go so far if the health system’s first line of defense – primary health care – isn’t up to the task. Experts have already called attention to gaps in front line health supplies, such as masks, hand sanitizer, testing kits and vaccines. In the U.S., where we live, these gaps mean we’re now fighting a steep uphill battle in containing the virus. But few are talking about shortcomings of the primary health care system, which is about far more than just supplies. Strong primary health care looks like a trusted nurse or doctor, who is always there and trained to answer your questions. It means comprehensive quality care – in one place – tailored to your health needs. It means confidence that your local health center is safe and ready with quality medicines and supplies, regardless of outbreaks or changes in the world around you. Whether or not a crisis is looming, primary health care should be the first place everyone turns for health services or information, using hospitals only when truly necessary. For most people worldwide, though, access to quality primary health care depends on where you live or how much money you have. In fact, primary health care is chronically underfunded and deprioritized in rich and poor countries alike. COVID-19 has made it painfully clear that we can’t afford to have weak primary health care continue as our reality. In the U.S., fragmented care and lack of clear communication from experts has left people anxious about where to turn, making unnecessary visits to emergency rooms. In Italy, where the health care system has experienced cuts in funding over the past decade, we’re seeing the dire consequences of having too few staff and supplies. And across Africa, where the virus is rapidly spreading, misinformation and mistrust of health systems could keep people from seeking care – as we saw in Liberia and other West African countries during the 2014-2016 Ebola outbreak. This doesn’t have to be the case. There are clear steps the world can take to fully unlock the potential of primary health care, both to help us respond to the current pandemic and prepare for disease outbreaks we’ll inevitably face in the future. In the short-term, primary care providers should be considered central partners and first responders in this crisis, helping to test and triage the most at-risk patients, and reducing the burden on already-overwhelmed hospitals. Leaders owe them reliable information and tools, including additional support for logistics and staffing and critical supplies such as rapid test kits and personal protective equipment. Such approaches have paid off in a big way in countries like Singapore, where they’ve been able to mobilize a trusted and well-resourced primary health care workforce. Trusted primary care providers can also play a key role disseminating prevention messages to the public and high-risk groups, and encouraging social distancing by offering telehealth services for people with COVID-19 symptoms and chronic disease patients alike. In the weeks and months ahead, countries and donors should also resist the urge to earmark all response funds for coronavirus-specific care. As health systems approach breaking point, flexible funds for primary health care can aid the response and prevent disruptions to essential daily life-saving services, from delivering babies to treating chronic conditions. This approach will also help head off future epidemics, rather than promote a continuous cycle of “Band-Aid” investments that ignore the root of the problem. In the long term, governments must significantly increase spending on quality primary health care to make sure it’s well-resourced and affordable – so that no one has to choose between seeking care and paying their bills. The World Health Organization estimates that it will take an additional $200 billion annually to fund quality primary health care for all; well-spent, this could save 60 million lives in low- and middle-income countries alone. Finally, we can’t fix problems that we can’t diagnose. Countries desperately need better ways to take the temperature of their primary health care systems. At the Primary Health Care Performance Initiative, a partnership of country policymakers, health systems managers and advocates, we’re working with governments around the world to collect more and better data, equipping leaders to pinpoint weaknesses and improve health systems before the next pandemic hits. Counting treatments or people infected is not enough – we need to know if people trust and value their care; if health workers are trained, resourced and motivated; and if clinics are safe, clean and well-managed. We are only as prepared as the world’s weakest health system. The world has repeatedly failed to learn this before. We must do better beginning today, or this won’t be the last time we pay the price. ______________________________________________________________________________ Dan Schwarz, MD MPH is the Director of Primary Health Care at Ariadne Labs and an Adviser to the WHO and the Lancet Commission on Noncommunicable Diseases and Poverty, with over a decade of experience in global healthcare delivery. Beth Tritter is the Executive Director of the Primary Health Care Performance Initiative (PHCPI). PHCPI was founded in 2015 by the Bill & Melinda Gates Foundation, the World Health Organization and the World Bank Group, and now including UNICEF, in collaboration with Ariadne Labs and Results for Development. She previously served in the U.S. government as the Millennium Challenge Corporation’s Vice President for Policy and Evaluation. Image Credits: Bill & Melinda Gates Foundation/Samantha Reinders. WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Blood Plasma Of Recovered COVID-19 Patients Approved By US FDA For Investigational Use As Treatment 25/03/2020 Grace Ren Technician separates blood components into plasma, platelets, and red blood cells. The US Food and Drug Administration granted investigational emergency use approval for convalescent blood plasma as a potential COVID-19 treatment on Tuesday. Cloned antibodies from recovered COVID-19 patients showed impressive ability to neutralize SARS-CoV-2, the virus behind the disease, in cell cultures, according to a paper published Wednesday on the preprint server BioRxiv. Two of the most potent antibodies isolated, 299 P2C-1F11 and P2B-2F6, were able to bind so strongly to the virus that it reduced the percentage of virus attaching to live cells by almost 100%. Patients who have recovered from COVID-19 have antibodies in their blood that might be effective against the infection. These antibodies, found in the blood plasma – or the transparent, liquid part of the blood – could be then injected into COVID-19 patients to provide some immunity as the host immune system ramps up its own response. Early evidence from a Chinese trial in 10 patients showed “significant improvement” within 1 to 3 days after receiving a blood plasma transfusion, with 2 of the 3 patients weaned off mechanical ventilation shortly after the transfusion. New York State, which has about half of the 62,873 COVID-19 cases in the United States, is set to roll-out the first treatments within the next week, Governor Andrew Cuomo said on Monday. According to CNN, New York will be first recruiting recovered patients from New Rochelle, which saw the first cluster of cases in the state and thus has the largest cluster of recovered COVID-19 patients eligible to donate blood. Although promising, convalescent blood plasma is not effective for every disease, says the US FDA, including for viral diseases such as Ebola. Success in cell culture studies must still be replicated in human patients. However, experts have been pushing since January for more serious consideration of such treatment as a potential COVID-19 treatment, based on limited success in treating other coronaviruses, such as SARS and MERS. Under US FDA regulations, the treatment is only available to patients with a lab confirmed positive COVID-19 test experiencing severe disease, and enrolled in a clinical trial. A recovered patient with a prior lab-confirmed COVID19 diagnosis may donate blood plasma 2 weeks after their symptoms resolve, and only if they then test negative for COVID-19. The collected blood plasma can then be immediately infused into COVID-19 patients with severe disease, after the donation is screened for other blood-borne diseases. Other trials of blood plasma or plasma-derived products are already taking place at the University of Washington in St. Louis, Missouri. Scientists there submitted a investigational new drug application to the FDA on 18 March. In a related development, the pharma firm Takeda announced on 4 March that the company initiated development of an antibody treatment derived from plasma. 61 Organizations Call On EU To Ensure Accessibility of New Coronavirus Products Some 61 NGOs released an open letter on Wednesday calling on the European Union and national governments to incorporate access and affordability products into approvals for new COVID-19 products. The groups also said that governments should exclusive licensing, and require disclosure of public contributions to drug development as part of COVID-19 research. “In the current pandemic situation when time is of the essence and it is critical that any treatment developed with public funds is made as widely available as possible, the call for greater transparency and accountability for public funds used in biomedical R&D is particularly pertinent,” said Jaume Vidal, senior policy advisor at Health Action International, the access organization that coordinated the letter, in an interview with Health Policy Watch. Vidal added that making COVID-19 drugs as widely available as possible “necessarily entails” affordability requirements, and that the ask on non-exclusive licensing was a “specific demand to counter” medicines shortages, which can be caused by limiting the number of producers. A recent fast-track US $45 million call for proposals on developing therapeutics and diagnostics for COVID-19 by the Innovative Medicine Initiative (IMI) did not require affordability clauses, according to the letter. Affordability clauses help ensure that any successful products developed by grant money are not priced out of reach of low- or middle-income countries, or poorer health systems. Additionally, the NGOs said that granting exclusive licenses for successful COVID-19 product should not be allowed, just days after the US FDA granted Gilead’s remdesivir, a promising coronavirus antiviral, “orphan drug” status – giving the pharma company 7 years of US market exclusivity. However in an unusual about-face, the company requested the FDA rescind the “orphan drug” designation on Wednesday after facing a public backlash from medicines access advocates. The open letter said that market exclusivity on COVID-19 products could create “excessively high prices or over-reliance on a single source, which can increase the possibility of shortages. “An effective response requires that all these necessary medical tools are free of charge at the point of delivery, particularly for vulnerable populations,” the organizations stated in the letter. Europe Remains the Epicentre, But Some Countries Can Still Stem the Tide. The letter was released as active cases in Europe surged to 197,842 cases and 12,822 total deaths. Italy and Spain remain the worst affected countries with 54,030 and 40,382 active cases respectively; however, Switzerland with 9765 cases has now overtaken Italy to have the highest number of cases per capita. In Italy, fatalities rose to 743 deaths, after several days of lower numbers. Prime Minister Giuseppe Conte increased fines for leaving homes to up to 3,000 euros from the previous maximum of 206 euros. In Spain, an ice rink in Madrid has been converted into a temporary morgue, according to El Paiz. Meanwhile, across the Atlantic, cases shot up in the United States to 62,873, with 30,811 alone in New York State. The uptick of cases in the state is also driven by increased testing. The state is testing more than 16,000 people a day, a higher per capita testing rate than even China or South Korea, according to a press release from Governor Andrew Cuomo’s office. However, other states in the US are still facing test kit shortages – amid mixed messages from the White House on whether most US workers will be able to return to their jobs again by Easter. In Latin America, Brazil remains the most affected country at 2155 cases followed by Chile with 903 and Ecuador with 775 cases. As the number of cases escalates in Chile, the government is facing pressure to introduce a national lockdown, following in Argentina’s footsteps, according to National Public Radio. Chilean President Sebastian Piñera has declared the situation as “a state of catastrophe” and has deployed the armed forces to maintain infrastructure and supply lines. According to the latest WHO situation report, the total number of cases in the WHO African Region is 1305 -315 more than the previous day – and deaths increased from 23 to 26. South Africa, Algeria and Burkina Faso are the most affected countries in the region with 402, 231 and 99 cases respectively. President of the Democratic Republic of the Congo Felix Tshisekedi declared a “state of emergency” Wednesday morning as the case count hit 45 cases and 3 deaths, closing country borders and banning all flights, even domestic ones, from entering Kinshasa, in an attempt to lock down the country’s dense urban center. However, according to World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, around the world more than 150 countries still have less than 100 cases – and those nations still had a chance to prevent widespread disruptions from COVID-19. “Aggressive measures to find, isolate, test, treat and trace are not only the best and fastest way out of extreme social and economic restrictions – they’re also the best way to prevent them,” said Dr Tedros. Active cases around the world as of 11PM CET 25 March. Right column shows cumulative case count. Numbers are rapidly changing. This story was updated 27 March 2020. Image Credits: Banc de Sang i Teixits, Johns Hopkins CSSE. Médecins Sans Frontières Announces Campaign For $5 COVID-19 Test On ‘GeneXpert’ TB Platform 24/03/2020 Grace Ren Healthcare worker runs a test on a GeneXpert machine. Médecins Sans Frontiéres (MSF) on Tuesday launched a campaign to push for a US $5 price tag on a new COVID-19 rapid diagnostic test that can be used on GeneXpert, a diagnostic instrument widely deployed around the world for diagnosing tuberculosis. The test for SARS-CoV-2, the virus that causes COVID-19, received US Food and Drug Administration emergency use approval just last Friday, and represents a hope for scaling up COVID-19 testing in low- and middle-income countries. The MSF announcement coincided with World Tuberculosis Day, and reflected one of the many ways in which the battle against one of the world’s oldest respiratory diseases, TB and the battle against the newest threat to lung health from COVID-19, are now converging. “The Xpert Xpress SARS-CoV-2 Test for testing for the novel coronavirus should be no more than $5 a cartridge,” said Sharonann Lynch, HIV and TB Policy Advisor at Médecins Sans Frontiéres/Doctors Without Borders’ Access Campaign, in an interview with Health Policy Watch. The US company that produces GeneXpert tests Cepheid has set the coronavirus test price at $19.80 per cartridge for 145 developing countries, according to Lynch. In high income countries, the coronavirus test will cost $35 per cartridge. The TB test for the platform currently costs $9.98 per cartridge for low- and middle- income countries. An HIV diagnostic test, which can also be performed on the platform, costs $14 per cartridge. However, even the US $10 price on the TB test is too high for many countries, said Lynch. Thus, Cepheid could “drastically lower the price to $5 per test.” An assessment of other GeneXpert tests by MSF and Cambridge Consultants found that a US $5 price tag per cartridge could still generate profit for Cepheid, as the ‘cost of goods’ – or the cost of materials, manufacturing, labour, overhead, intellectual property, and other indirect expenses – is estimated to be only US $3. The campaign for a $US 5 coronavirus test is an extension of an existing ‘Time for 5’ campaign by MSF to knock down prices for TB and HIV test cartridges to US $5 a piece. WHO Releases New Guidelines For Preventative TB Treatment Also on World Tuberculosis Day, the World Health Organization released new guidelines to scale up new, and dramatically shorter preventative regimens for latent tuberculosis (TB), one of mankind’s oldest and deadliest diseases. “COVID-19 is highlighting just how vulnerable people with lung diseases and weakened immune systems can be,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Millions of people need to be able to take TB preventative treatment to stop the onset of disease, avert suffering, and save lives.” In the context of the COVID-19 pandemic, “early evidence suggests that people with TB will be more susceptible to coronavirus and severe COVID-19,” said Lynch. Thus, scaling up preventative TB treatment could also help reduce negative impacts of the rapidly accelerating COVID-19 pandemic according to the WHO, which has also released guidance on how to sustain TB treatment during the COVID-19 emergency. Tuberculosis remains the world’s top infectious killer – in 2018 there were an estimated 10 million new symptomatic infections and 1.5 million deaths. About a quarter of the world’s population is estimated to be infected with TB bacteria, but are not sick nor contagious. However, those with such “latent” TB are at higher risk of developing active disease, which can be particularly deadly in immunocompromised people. Treating latent TB remains the most effective strategy to prevent the progression to active disease and protect others against onwards transmission – but has been largely neglected as a part of TB control programmes. To date, only 430,000 of the target 24 million contacts of people with active TB and only 1.8 million of the target 6 million people living with HIV have received preventative treatment. The new WHO guidelines recommend new shorter regimens for preventative treatment for latent forms of the disease, ranging from a 1 month daily rifapentine/isoniazid treatment to 4 months of daily rifampicin alone – shaving off months from the previous standard 6-month isoniazid treatment. The guidelines also recommend the rapid scale-up of preventative TB treatment among populations at highest risk, including household contacts of TB patients, people living with HIV, and those with lowered immunity or living in crowded settings; integrating TB preventative treatment into case-finding efforts for active TB, and using tuberculin skin tests or an interferon-gamma release assay (IGRA) to test for infection when tests are available. Woman puts on a facemask at a healthcare facility for drug-resistant TB patients in New Delhi, India Leveraging TB Knowledge To Fight COVID-19 As the COVID-19 pandemic accelerates, the World Health Organization and leading TB organizations also are promoting a joint approach to tackling both the world’s oldest and newest respiratory threats. New WHO guidance for TB programme directors recommends leveraging TB prevention strategies, technologies and logistics, and programmatic staff to tackle the diseases. TB staff, with years of experience in low-resource settings, are well positioned to offer technical assistance in contact tracing and active case finding, the cornerstones of a robust COVID-19 response. “We know what works to fight COVID-19 from our experience and the tools we have developed to end TB: infection control, wide-spread testing, contact tracing, X-rays, artificial intelligence, telemedicine and psycho-social support,” said José Luis Castro, executive director of The International Union Against TB and Lung Diseases (The Union) in a press release. However, some TB advocates have also expressed concerns that the global focus on COVID-19 could shift resources from essential TB treatment services. “The COVID emergency should marshall all necessary resources, but not at the expense of TB services, including TB testing, or people with TB,” said Lynch. Additionally, with countries enacting more strict travel restrictions in the face of accelerating COVID-19 outbreaks, it may be time to try a new model of care for TB patients For those with active TB, a full treatment course is at least 6 months and treatment is usually directly observed by providers, which means patients or healthcare workers must travel daily to meet in clinics or homes to administer treatment. “To reduce the risk for existing patients, [we] must seek ways to re-design models of care to provide treatment for people with TB in the community and use remote telemedicine and web apps to support them,” Lynch suggested. Image Credits: WHO/UNITAID, CNS Images. As Coronavirus Spreads, It’s Time To Diagnose & Treat Our Broken Primary Health Care Systems 24/03/2020 Dan Schwarz & Beth Tritter Staff members administering vaccinations at Kabuga Health Center in the Gasabo district of Kigali (Rusororo sector), Rwanda on June 28, 2018. As the explosive impact of COVID-19 ripples globally, there’s a clear plea from many regions and countries: stay home and help “flatten the curve” of infection. People from China to Italy have seen the consequences of the virus spreading too quickly with hospitals overwhelmed and doctors forced to make heartbreaking decisions about who lives and dies. It’s natural to hear these stories and blame a lack of pandemic preparedness. But emergency response can only go so far if the health system’s first line of defense – primary health care – isn’t up to the task. Experts have already called attention to gaps in front line health supplies, such as masks, hand sanitizer, testing kits and vaccines. In the U.S., where we live, these gaps mean we’re now fighting a steep uphill battle in containing the virus. But few are talking about shortcomings of the primary health care system, which is about far more than just supplies. Strong primary health care looks like a trusted nurse or doctor, who is always there and trained to answer your questions. It means comprehensive quality care – in one place – tailored to your health needs. It means confidence that your local health center is safe and ready with quality medicines and supplies, regardless of outbreaks or changes in the world around you. Whether or not a crisis is looming, primary health care should be the first place everyone turns for health services or information, using hospitals only when truly necessary. For most people worldwide, though, access to quality primary health care depends on where you live or how much money you have. In fact, primary health care is chronically underfunded and deprioritized in rich and poor countries alike. COVID-19 has made it painfully clear that we can’t afford to have weak primary health care continue as our reality. In the U.S., fragmented care and lack of clear communication from experts has left people anxious about where to turn, making unnecessary visits to emergency rooms. In Italy, where the health care system has experienced cuts in funding over the past decade, we’re seeing the dire consequences of having too few staff and supplies. And across Africa, where the virus is rapidly spreading, misinformation and mistrust of health systems could keep people from seeking care – as we saw in Liberia and other West African countries during the 2014-2016 Ebola outbreak. This doesn’t have to be the case. There are clear steps the world can take to fully unlock the potential of primary health care, both to help us respond to the current pandemic and prepare for disease outbreaks we’ll inevitably face in the future. In the short-term, primary care providers should be considered central partners and first responders in this crisis, helping to test and triage the most at-risk patients, and reducing the burden on already-overwhelmed hospitals. Leaders owe them reliable information and tools, including additional support for logistics and staffing and critical supplies such as rapid test kits and personal protective equipment. Such approaches have paid off in a big way in countries like Singapore, where they’ve been able to mobilize a trusted and well-resourced primary health care workforce. Trusted primary care providers can also play a key role disseminating prevention messages to the public and high-risk groups, and encouraging social distancing by offering telehealth services for people with COVID-19 symptoms and chronic disease patients alike. In the weeks and months ahead, countries and donors should also resist the urge to earmark all response funds for coronavirus-specific care. As health systems approach breaking point, flexible funds for primary health care can aid the response and prevent disruptions to essential daily life-saving services, from delivering babies to treating chronic conditions. This approach will also help head off future epidemics, rather than promote a continuous cycle of “Band-Aid” investments that ignore the root of the problem. In the long term, governments must significantly increase spending on quality primary health care to make sure it’s well-resourced and affordable – so that no one has to choose between seeking care and paying their bills. The World Health Organization estimates that it will take an additional $200 billion annually to fund quality primary health care for all; well-spent, this could save 60 million lives in low- and middle-income countries alone. Finally, we can’t fix problems that we can’t diagnose. Countries desperately need better ways to take the temperature of their primary health care systems. At the Primary Health Care Performance Initiative, a partnership of country policymakers, health systems managers and advocates, we’re working with governments around the world to collect more and better data, equipping leaders to pinpoint weaknesses and improve health systems before the next pandemic hits. Counting treatments or people infected is not enough – we need to know if people trust and value their care; if health workers are trained, resourced and motivated; and if clinics are safe, clean and well-managed. We are only as prepared as the world’s weakest health system. The world has repeatedly failed to learn this before. We must do better beginning today, or this won’t be the last time we pay the price. ______________________________________________________________________________ Dan Schwarz, MD MPH is the Director of Primary Health Care at Ariadne Labs and an Adviser to the WHO and the Lancet Commission on Noncommunicable Diseases and Poverty, with over a decade of experience in global healthcare delivery. Beth Tritter is the Executive Director of the Primary Health Care Performance Initiative (PHCPI). PHCPI was founded in 2015 by the Bill & Melinda Gates Foundation, the World Health Organization and the World Bank Group, and now including UNICEF, in collaboration with Ariadne Labs and Results for Development. She previously served in the U.S. government as the Millennium Challenge Corporation’s Vice President for Policy and Evaluation. Image Credits: Bill & Melinda Gates Foundation/Samantha Reinders. WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Médecins Sans Frontières Announces Campaign For $5 COVID-19 Test On ‘GeneXpert’ TB Platform 24/03/2020 Grace Ren Healthcare worker runs a test on a GeneXpert machine. Médecins Sans Frontiéres (MSF) on Tuesday launched a campaign to push for a US $5 price tag on a new COVID-19 rapid diagnostic test that can be used on GeneXpert, a diagnostic instrument widely deployed around the world for diagnosing tuberculosis. The test for SARS-CoV-2, the virus that causes COVID-19, received US Food and Drug Administration emergency use approval just last Friday, and represents a hope for scaling up COVID-19 testing in low- and middle-income countries. The MSF announcement coincided with World Tuberculosis Day, and reflected one of the many ways in which the battle against one of the world’s oldest respiratory diseases, TB and the battle against the newest threat to lung health from COVID-19, are now converging. “The Xpert Xpress SARS-CoV-2 Test for testing for the novel coronavirus should be no more than $5 a cartridge,” said Sharonann Lynch, HIV and TB Policy Advisor at Médecins Sans Frontiéres/Doctors Without Borders’ Access Campaign, in an interview with Health Policy Watch. The US company that produces GeneXpert tests Cepheid has set the coronavirus test price at $19.80 per cartridge for 145 developing countries, according to Lynch. In high income countries, the coronavirus test will cost $35 per cartridge. The TB test for the platform currently costs $9.98 per cartridge for low- and middle- income countries. An HIV diagnostic test, which can also be performed on the platform, costs $14 per cartridge. However, even the US $10 price on the TB test is too high for many countries, said Lynch. Thus, Cepheid could “drastically lower the price to $5 per test.” An assessment of other GeneXpert tests by MSF and Cambridge Consultants found that a US $5 price tag per cartridge could still generate profit for Cepheid, as the ‘cost of goods’ – or the cost of materials, manufacturing, labour, overhead, intellectual property, and other indirect expenses – is estimated to be only US $3. The campaign for a $US 5 coronavirus test is an extension of an existing ‘Time for 5’ campaign by MSF to knock down prices for TB and HIV test cartridges to US $5 a piece. WHO Releases New Guidelines For Preventative TB Treatment Also on World Tuberculosis Day, the World Health Organization released new guidelines to scale up new, and dramatically shorter preventative regimens for latent tuberculosis (TB), one of mankind’s oldest and deadliest diseases. “COVID-19 is highlighting just how vulnerable people with lung diseases and weakened immune systems can be,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Millions of people need to be able to take TB preventative treatment to stop the onset of disease, avert suffering, and save lives.” In the context of the COVID-19 pandemic, “early evidence suggests that people with TB will be more susceptible to coronavirus and severe COVID-19,” said Lynch. Thus, scaling up preventative TB treatment could also help reduce negative impacts of the rapidly accelerating COVID-19 pandemic according to the WHO, which has also released guidance on how to sustain TB treatment during the COVID-19 emergency. Tuberculosis remains the world’s top infectious killer – in 2018 there were an estimated 10 million new symptomatic infections and 1.5 million deaths. About a quarter of the world’s population is estimated to be infected with TB bacteria, but are not sick nor contagious. However, those with such “latent” TB are at higher risk of developing active disease, which can be particularly deadly in immunocompromised people. Treating latent TB remains the most effective strategy to prevent the progression to active disease and protect others against onwards transmission – but has been largely neglected as a part of TB control programmes. To date, only 430,000 of the target 24 million contacts of people with active TB and only 1.8 million of the target 6 million people living with HIV have received preventative treatment. The new WHO guidelines recommend new shorter regimens for preventative treatment for latent forms of the disease, ranging from a 1 month daily rifapentine/isoniazid treatment to 4 months of daily rifampicin alone – shaving off months from the previous standard 6-month isoniazid treatment. The guidelines also recommend the rapid scale-up of preventative TB treatment among populations at highest risk, including household contacts of TB patients, people living with HIV, and those with lowered immunity or living in crowded settings; integrating TB preventative treatment into case-finding efforts for active TB, and using tuberculin skin tests or an interferon-gamma release assay (IGRA) to test for infection when tests are available. Woman puts on a facemask at a healthcare facility for drug-resistant TB patients in New Delhi, India Leveraging TB Knowledge To Fight COVID-19 As the COVID-19 pandemic accelerates, the World Health Organization and leading TB organizations also are promoting a joint approach to tackling both the world’s oldest and newest respiratory threats. New WHO guidance for TB programme directors recommends leveraging TB prevention strategies, technologies and logistics, and programmatic staff to tackle the diseases. TB staff, with years of experience in low-resource settings, are well positioned to offer technical assistance in contact tracing and active case finding, the cornerstones of a robust COVID-19 response. “We know what works to fight COVID-19 from our experience and the tools we have developed to end TB: infection control, wide-spread testing, contact tracing, X-rays, artificial intelligence, telemedicine and psycho-social support,” said José Luis Castro, executive director of The International Union Against TB and Lung Diseases (The Union) in a press release. However, some TB advocates have also expressed concerns that the global focus on COVID-19 could shift resources from essential TB treatment services. “The COVID emergency should marshall all necessary resources, but not at the expense of TB services, including TB testing, or people with TB,” said Lynch. Additionally, with countries enacting more strict travel restrictions in the face of accelerating COVID-19 outbreaks, it may be time to try a new model of care for TB patients For those with active TB, a full treatment course is at least 6 months and treatment is usually directly observed by providers, which means patients or healthcare workers must travel daily to meet in clinics or homes to administer treatment. “To reduce the risk for existing patients, [we] must seek ways to re-design models of care to provide treatment for people with TB in the community and use remote telemedicine and web apps to support them,” Lynch suggested. Image Credits: WHO/UNITAID, CNS Images. As Coronavirus Spreads, It’s Time To Diagnose & Treat Our Broken Primary Health Care Systems 24/03/2020 Dan Schwarz & Beth Tritter Staff members administering vaccinations at Kabuga Health Center in the Gasabo district of Kigali (Rusororo sector), Rwanda on June 28, 2018. As the explosive impact of COVID-19 ripples globally, there’s a clear plea from many regions and countries: stay home and help “flatten the curve” of infection. People from China to Italy have seen the consequences of the virus spreading too quickly with hospitals overwhelmed and doctors forced to make heartbreaking decisions about who lives and dies. It’s natural to hear these stories and blame a lack of pandemic preparedness. But emergency response can only go so far if the health system’s first line of defense – primary health care – isn’t up to the task. Experts have already called attention to gaps in front line health supplies, such as masks, hand sanitizer, testing kits and vaccines. In the U.S., where we live, these gaps mean we’re now fighting a steep uphill battle in containing the virus. But few are talking about shortcomings of the primary health care system, which is about far more than just supplies. Strong primary health care looks like a trusted nurse or doctor, who is always there and trained to answer your questions. It means comprehensive quality care – in one place – tailored to your health needs. It means confidence that your local health center is safe and ready with quality medicines and supplies, regardless of outbreaks or changes in the world around you. Whether or not a crisis is looming, primary health care should be the first place everyone turns for health services or information, using hospitals only when truly necessary. For most people worldwide, though, access to quality primary health care depends on where you live or how much money you have. In fact, primary health care is chronically underfunded and deprioritized in rich and poor countries alike. COVID-19 has made it painfully clear that we can’t afford to have weak primary health care continue as our reality. In the U.S., fragmented care and lack of clear communication from experts has left people anxious about where to turn, making unnecessary visits to emergency rooms. In Italy, where the health care system has experienced cuts in funding over the past decade, we’re seeing the dire consequences of having too few staff and supplies. And across Africa, where the virus is rapidly spreading, misinformation and mistrust of health systems could keep people from seeking care – as we saw in Liberia and other West African countries during the 2014-2016 Ebola outbreak. This doesn’t have to be the case. There are clear steps the world can take to fully unlock the potential of primary health care, both to help us respond to the current pandemic and prepare for disease outbreaks we’ll inevitably face in the future. In the short-term, primary care providers should be considered central partners and first responders in this crisis, helping to test and triage the most at-risk patients, and reducing the burden on already-overwhelmed hospitals. Leaders owe them reliable information and tools, including additional support for logistics and staffing and critical supplies such as rapid test kits and personal protective equipment. Such approaches have paid off in a big way in countries like Singapore, where they’ve been able to mobilize a trusted and well-resourced primary health care workforce. Trusted primary care providers can also play a key role disseminating prevention messages to the public and high-risk groups, and encouraging social distancing by offering telehealth services for people with COVID-19 symptoms and chronic disease patients alike. In the weeks and months ahead, countries and donors should also resist the urge to earmark all response funds for coronavirus-specific care. As health systems approach breaking point, flexible funds for primary health care can aid the response and prevent disruptions to essential daily life-saving services, from delivering babies to treating chronic conditions. This approach will also help head off future epidemics, rather than promote a continuous cycle of “Band-Aid” investments that ignore the root of the problem. In the long term, governments must significantly increase spending on quality primary health care to make sure it’s well-resourced and affordable – so that no one has to choose between seeking care and paying their bills. The World Health Organization estimates that it will take an additional $200 billion annually to fund quality primary health care for all; well-spent, this could save 60 million lives in low- and middle-income countries alone. Finally, we can’t fix problems that we can’t diagnose. Countries desperately need better ways to take the temperature of their primary health care systems. At the Primary Health Care Performance Initiative, a partnership of country policymakers, health systems managers and advocates, we’re working with governments around the world to collect more and better data, equipping leaders to pinpoint weaknesses and improve health systems before the next pandemic hits. Counting treatments or people infected is not enough – we need to know if people trust and value their care; if health workers are trained, resourced and motivated; and if clinics are safe, clean and well-managed. We are only as prepared as the world’s weakest health system. The world has repeatedly failed to learn this before. We must do better beginning today, or this won’t be the last time we pay the price. ______________________________________________________________________________ Dan Schwarz, MD MPH is the Director of Primary Health Care at Ariadne Labs and an Adviser to the WHO and the Lancet Commission on Noncommunicable Diseases and Poverty, with over a decade of experience in global healthcare delivery. Beth Tritter is the Executive Director of the Primary Health Care Performance Initiative (PHCPI). PHCPI was founded in 2015 by the Bill & Melinda Gates Foundation, the World Health Organization and the World Bank Group, and now including UNICEF, in collaboration with Ariadne Labs and Results for Development. She previously served in the U.S. government as the Millennium Challenge Corporation’s Vice President for Policy and Evaluation. Image Credits: Bill & Melinda Gates Foundation/Samantha Reinders. WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
As Coronavirus Spreads, It’s Time To Diagnose & Treat Our Broken Primary Health Care Systems 24/03/2020 Dan Schwarz & Beth Tritter Staff members administering vaccinations at Kabuga Health Center in the Gasabo district of Kigali (Rusororo sector), Rwanda on June 28, 2018. As the explosive impact of COVID-19 ripples globally, there’s a clear plea from many regions and countries: stay home and help “flatten the curve” of infection. People from China to Italy have seen the consequences of the virus spreading too quickly with hospitals overwhelmed and doctors forced to make heartbreaking decisions about who lives and dies. It’s natural to hear these stories and blame a lack of pandemic preparedness. But emergency response can only go so far if the health system’s first line of defense – primary health care – isn’t up to the task. Experts have already called attention to gaps in front line health supplies, such as masks, hand sanitizer, testing kits and vaccines. In the U.S., where we live, these gaps mean we’re now fighting a steep uphill battle in containing the virus. But few are talking about shortcomings of the primary health care system, which is about far more than just supplies. Strong primary health care looks like a trusted nurse or doctor, who is always there and trained to answer your questions. It means comprehensive quality care – in one place – tailored to your health needs. It means confidence that your local health center is safe and ready with quality medicines and supplies, regardless of outbreaks or changes in the world around you. Whether or not a crisis is looming, primary health care should be the first place everyone turns for health services or information, using hospitals only when truly necessary. For most people worldwide, though, access to quality primary health care depends on where you live or how much money you have. In fact, primary health care is chronically underfunded and deprioritized in rich and poor countries alike. COVID-19 has made it painfully clear that we can’t afford to have weak primary health care continue as our reality. In the U.S., fragmented care and lack of clear communication from experts has left people anxious about where to turn, making unnecessary visits to emergency rooms. In Italy, where the health care system has experienced cuts in funding over the past decade, we’re seeing the dire consequences of having too few staff and supplies. And across Africa, where the virus is rapidly spreading, misinformation and mistrust of health systems could keep people from seeking care – as we saw in Liberia and other West African countries during the 2014-2016 Ebola outbreak. This doesn’t have to be the case. There are clear steps the world can take to fully unlock the potential of primary health care, both to help us respond to the current pandemic and prepare for disease outbreaks we’ll inevitably face in the future. In the short-term, primary care providers should be considered central partners and first responders in this crisis, helping to test and triage the most at-risk patients, and reducing the burden on already-overwhelmed hospitals. Leaders owe them reliable information and tools, including additional support for logistics and staffing and critical supplies such as rapid test kits and personal protective equipment. Such approaches have paid off in a big way in countries like Singapore, where they’ve been able to mobilize a trusted and well-resourced primary health care workforce. Trusted primary care providers can also play a key role disseminating prevention messages to the public and high-risk groups, and encouraging social distancing by offering telehealth services for people with COVID-19 symptoms and chronic disease patients alike. In the weeks and months ahead, countries and donors should also resist the urge to earmark all response funds for coronavirus-specific care. As health systems approach breaking point, flexible funds for primary health care can aid the response and prevent disruptions to essential daily life-saving services, from delivering babies to treating chronic conditions. This approach will also help head off future epidemics, rather than promote a continuous cycle of “Band-Aid” investments that ignore the root of the problem. In the long term, governments must significantly increase spending on quality primary health care to make sure it’s well-resourced and affordable – so that no one has to choose between seeking care and paying their bills. The World Health Organization estimates that it will take an additional $200 billion annually to fund quality primary health care for all; well-spent, this could save 60 million lives in low- and middle-income countries alone. Finally, we can’t fix problems that we can’t diagnose. Countries desperately need better ways to take the temperature of their primary health care systems. At the Primary Health Care Performance Initiative, a partnership of country policymakers, health systems managers and advocates, we’re working with governments around the world to collect more and better data, equipping leaders to pinpoint weaknesses and improve health systems before the next pandemic hits. Counting treatments or people infected is not enough – we need to know if people trust and value their care; if health workers are trained, resourced and motivated; and if clinics are safe, clean and well-managed. We are only as prepared as the world’s weakest health system. The world has repeatedly failed to learn this before. We must do better beginning today, or this won’t be the last time we pay the price. ______________________________________________________________________________ Dan Schwarz, MD MPH is the Director of Primary Health Care at Ariadne Labs and an Adviser to the WHO and the Lancet Commission on Noncommunicable Diseases and Poverty, with over a decade of experience in global healthcare delivery. Beth Tritter is the Executive Director of the Primary Health Care Performance Initiative (PHCPI). PHCPI was founded in 2015 by the Bill & Melinda Gates Foundation, the World Health Organization and the World Bank Group, and now including UNICEF, in collaboration with Ariadne Labs and Results for Development. She previously served in the U.S. government as the Millennium Challenge Corporation’s Vice President for Policy and Evaluation. Image Credits: Bill & Melinda Gates Foundation/Samantha Reinders. WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WHO & FIFA Launch Campaign to “Kick Out Coronavirus” 23/03/2020 Editorial team Gianni Infantino (left) and Dr Tedros (right) sit at least 2m apart from each other at the WHO COVID-19 Press Briefing A World Health Organization – Fédération Internationale de Football Association (FIFA) joint campaign was launched on Monday to “kick out coronavirus” as global confirmed cases of COVID-19 soared past 350,000 Monday afternoon. “Football can reach millions of people, especially younger people, that public health officials cannot,” he added. It took 67 days to reach the first 100,000 cases, 11 more days to surpass 200,000 cases, and only 4 days to reach the 300,000 benchmark, noted Dr Tedros soberly in a press briefing. Alisson Becker, WHO Ambassador and Liverpool’s goalkeeper, joined Tedros via video chat and told the public, ”Health comes first in this moment. It’s time, like in football, to have teamwork. “That means everybody does their own job – that includes being safe, staying at home, following the local authorities’ advice…We can’t forget that for now we need to work as a team.” Gianni Infantino, president of FIFA, said that FIFA’s 211 member countries will be rolling out the “kick out coronavirus” campaign in the next few days. "⚽ can reach millions of people, especially younger people, that public health officials cannot. Today it’s my great pleasure to welcome my brother Gianni Infantino, President of @FIFAcom, to talk about our joint campaign to “Pass the message to kick out #coronavirus”-@DrTedros pic.twitter.com/ojGBcq9U4k — World Health Organization (WHO) (@WHO) March 23, 2020 Still, Dr Tedros told reporters that such physical distancing measures were “defensive” and not enough to quash the virus alone. “You can’t win a football game only by defending. You have to attack as well,” said Tedros. “To win, we need to attack the virus with aggressive and targeted tactics – testing every suspected case, isolating and caring for every confirmed case, and tracing and quarantining every close contact.” New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
New COVID-19 Rapid Diagnostic Approved On ‘GeneXpert’ TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries 23/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Technician in Indonesia runs a test on a GeneXpert machine (Source: USAID) US Food & Drug Administration authorization of a rapid COVID-19 test on the GeneXpert platform, one of the most widely-used TB diagnostic tools in the world, could be the first crack in the doorway to wider testing capacity in low- and middle-income countries, leading TB advocates told Health Policy Watch. There are some 23,000 GeneXpert devices worldwide, including an estimated 7000 -10,000 instruments scattered across Africa, Latin America and South-East Asia. While not a high-throughput device, the GeneXpert technology produced by the California-based firm Cepheid, can process nose swab samples in a mere 45 minutes. Cepheid received the US FDA emergency use authorization on Friday, March 20th for its new Xpert® Xpress SARS-CoV-2 diagnostic that can be processed on the GeneXpert platform. “The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” said Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union). “The need for testing is immense as we still don’t know the true number of people who are infected in the world,” she added, and adapting the GeneXpert platforms in low- and middle-income countries to COVID-19 testing coud be “easily and rapidly done,” since the technology is already well-known. However, she called on Cepheid to reduce the price of the COVID-19 test cartridges, which are reportedly set to sell for US$20 initially, to US$5 each, in order to make them more widely affordable in low- and middle-income countries. Many other pathogens, including HIV and hepatitis C, are also tested on GeneXpert, at a cost of between $US 9 – $US 20, to some 145 low- and middle-income countries that are eligible to procure the diagnostics at concessionary prices. In December 2019, Médecins Sans Frontières/Doctors Without Borders called upon Cepheid to reduce the costs of all its test cartridge to US$5, including service and maintenance, eligible countries. GeneXpert was widely deployed about decade ago to rapidly detect tuberculosis, including multi-drug resistant strains; it has since been adapted to enable rapid testing of many her pathogens, including not only HIV and hepatitis C, but also influenza, Ebola and sexually transmitted infections. Thanks to longstanding investments in TB infrastructure by The Global Fund, among others, the GeneXpert instruments are widely available in WHO’s Africa Region, which has now reported 1,396 confirmed COVID-19 cases across 43 countries. For instance, there were approximately 150 machines installed and running in the Democratic Republic of Congo, and ‘several “hundreds in nearby countries”, according to a 2018 report from Nature. GeneXpert tests are a “point-of-care” option that allows hospitals and clinics to perform diagnostic tests in-house, rather than sending them to outside labs. Additionally, the machine’s “automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7,” Cepheid President Warren Kocmond also noted in a press release. “During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities,” said David Persing, Chief Medical and Technology Officer at Cepheid. “An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources.” The new COVID-19 tests for the system will be shipped out from the Sunnyvale, California production facility starting this week. The first diagnostic tests appear to be destined for US domestic use, where there are approximately 5,000 machines, a source with another TB advocacy group told Health Policy Watch. “It appears that Cepheid is not yet positioning the COVID test for wide -scale use in low-income countries, where it could have the greatest impact,” the source said. Still, there is a “strong case” for activists to push “for ramping up global production to meet the testing needs of many low-income countries,” where GeneXpert networks are already in place. Usability In Rough Field Settings Still A Concern While automated, and designed for point-of-care testing, GeneXpert requires controlled, air-conditioned temperatures, so it’s not suitable for rough field conditions. However, it is still widely available in district health facilities and TB clinics across many low-income countries. “The advantage of GeneXpert is that testing can be done closer to the point of care (rather than only in centralized laboratories), which theoretically would improve turn-around times for test results as compared to laboratory instruments,” the source told Health Policy Watch. Ultimately, instrument-free immunoassays would be even cheaper and more appropriate for community-level testing. There are a number rapid tests in the pipeline, but none so far have been approved. In arrangements made a decade ago, prices for the GeneXpert device, which normally costs about US$17,000, as well as cartridge prices were reduced, for 145 eligible low- and middle-income countries. In 2016 alone, 6.9 million cartridges were procured in the public sector under the concessionary pricing arrangements. Tsering Llamo and Grace Ren contributed to this story Updated 24 March, 2020. Image Credits: Trishanty Rondonuwu, USAID Challenge TB. Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Protective Equipment Manufacturing Must Increase By 80-100 Times During COVID-19 Pandemic; WHO Projects 26 Million Healthcare Workers In Need 20/03/2020 Grace Ren New York Army National Guard members dressed in protective equipment. The photo contrasts sharply with reports of paltry protective equipment available in New York City hospitals. Manufacturing of personal protective equipment (PPE) for the COVID-19 pandemic response should be scaled up by 80 to 100 times to meet the projected needs of the healthcare workforce, the World Health Organization said on Friday. Amid a growing PPE shortage crisis in hotspots like Italy, the United States, and Iran, some 26 million healthcare workers around the world who may have to engage with COVID-19 patients could be in need of personal protective equipment, WHO projected. “The greatest tragedy is the prospect of losing a great part of our healthcare workforce that may lose their lives [to care for those who are sick],” WHO’s Executive Director of health emergencies, Mike Ryan, told reporters Friday. Ryan added that WHO was working on directing medical supplies into a “protected supply chain for health workers,” but at the moment the organization was also facing issues with transporting existing stock to countries in need. “We’re having issues with flights, issues with moving material around” due to some international travel restrictions, said Ryan. “We’re going to need to set up air bridges to bring staff and stuff to countries to help assist them.” WHO’s Director-General Dr Tedros Adhanom Ghebreyesus additionally added that the shortage of PPE could not be addressed “without political commitment of our leaders.” According to Dr Tedros countries should be taking three key steps: Increase production of protective equipment; Support cross-border mobility and lift export restrictions on protective equipment; Focus on equitable distribution, as all countries may not have access based on needs. Down at the community level, Maria Van Kerkhove, WHO’s technical lead on the COVID-19 crisis, said individuals who are not caring for a sick COVID-19 patient or sick themselves should not use masks in order to keep the supply available for healthcare workers. “There’s very serious discussions about use of masks – if you do not need to wear a mask, don’t hoard those masks. Make sure they are available for healthcare workers,” she said. “They’re making very difficult decisions about extended use or repeated use.” US Healthcare Workers Plead For More Government Support As PPE Stocks Run Low Amidst the global PPE shortage, healthcare staff around the United States are pleading with the federal government for assistance procuring personal protective equipment. Additionally, in some hospitals in the epicentres of US outbreaks, resident doctors are being refused COVID-19 tests unless they themselves show severe symptoms. One resident at a large hospital in New York City posted on social media that the new hospital policy is that a resident should continue working, even if they have mild upper respiratory infection symptoms. “We are being refused COVID tests as doctors. We are only deemed eligible if we develop [further] respiratory symptoms,” added the resident in their post. Another resident in New York City confirmed that this was a new policy at a different hospital, as New York City shifted from testing and tracing all suspect cases, to reserving COVID-19 tests for severe cases on Wednesday as cases surged. On Tuesday, a federal official told the Washington Post that there were reports of more than 60 health workers infected with COVID-19 in the US. However, US President Donald Trump told reporters in a press briefing Thursday that the federal government has yet to take action under the “Defense Production Act” invoked on Tuesday to direct American manufacturing towards producing supplies for the COVID-19 response. Vice President Mike Pence insisted that “35 million masks” manufactured by 3M, a major respirator production company “were immediately available” for hospitals to purchase, although social media reports from healthcare providers indicated a severe shortage on the ground. Desperate healthcare workers are calling on the US government to step up. Said the NYC resident, “there has been no government-issued PPE provided to any hospital as of yet… we also need help from the government.” The US CDC loosened PPE guidance to recommend “facemasks as an acceptable alternative when the supply chain of respirators cannot meet the demand.” Respirators, masks which filter inspired air rather than just protecting against splashes and sprays, offer a higher level of protection against droplet and aerosol transmission than surgical masks. A widely circulated petition submitted by three physicians on Change.com, which has gathered more than 700,000 signatures in 48 hours, pleaded “Recommendations to protect healthcare workers should not be based on what’s available; availability should be based on what is necessary.” According to the petition, some hospitals have taken the CDC’s advice to mean that surgical facemasks are the preferred PPE, and are thus rationing N95 respirators only for ‘aerosol-generating procedures’ such as intubation procedures required to place patients on ventilators. Sources told Health Policy Watch that some hospitals in the Tri-State area, which encompasses New York, Connecticut, and New Jersey, have begun collecting used N95 respirators to sanitize and reuse. But the concerns do not apply to New York City alone. The authors of the petition, who hail from San Diego, California, wrote “We urge the government to access the Strategic National Stockpile, [the federal government’s stock of emergency medical supplies], and to utilize both the public and private sector to immediately increase production of PPE supplies.” Active cases around the world as of 2:43PM CET 20 March. Right column shows cumulative case count. Numbers are rapidly changing. WHO Director-General Tells Young People “You Are Not Invincible” As Data Indicates Severe Disease In Those Under 50 As confirmed COVID-19 cases around the world rose to 246,276, and total deaths surpassed 10,000, Dr Tedros put out an urgent message to young people to treat the virus with greater caution, amidst an ongoing narrative that the virus is mostly serious in those above the age of 65 and with preexisting conditions. “You are not invincible,” said the WHO Director-General. “This virus could put you in hospital for weeks, or even kill you. “Even if you don’t get sick, the choices you make about where you go could be the difference between life and death for someone else.” Approximately two-thirds of cases in intensive care units in Italy, which now has 41,035 confirmed cases and 3,405 deaths, are under the age of 50, said Ryan. Cases across Europe increased to 99,302 cases and 5,174 deaths, increasingly placing health systems under strain. Swiss authorities warned on Friday that along with a shortage of diagnostic tests, parts of the country including Ticino canton in the south faced a looming shortage of hospital beds, according to the Local. With one of the highest case to population ratios in Europe, Switzerland has reported 4,164 cases and 43 deaths, according to the Swiss Federal Office of Public Health. Spain was battling the second largest outbreak In Europe with 18,077 cases and 833 deaths; followed by Germany with 16,290 cases and 44 deaths, and France with 10, 891 cases and 371 deaths. Across the Atlantic in the United States, some 38% of patients hospitalized for COVID-19 are under the age of 55, according to data released by the US CDC on Wednesday. Among 121 patients admitted to the intensive care unit, 48% were under the age of 65. The case count in the US rose to 14,250 confirmed cases and 250 deaths as outbreaks accelerated in New York State, California, and Washington State. In Iran, where the epidemic bloomed to 18,407 cases and 1,284 total deaths, Iranian Ministry of Health spokesman Kianush Jahanpur said that the coronavirus disease is currently killing one person every 10 minutes and some 50 people become infected with the virus every hour. The government urged people to stay home on Friday for Nowruz, the Persian New Year. More than 700 cases have been confirmed across WHO’s Africa region by Friday, when just one week ago the case count stood at 147 confirmed cases. With local transmission settling into twelve countries in the African region including South Africa, which has 202 confirmed cases, South African Health Minister Zweli Mkhize warned the country to scale up preparedness efforts for when the outbreak starts “affecting poor communities where families do not have enough rooms or spaces to quarantine those affected.” In Latin America, Brazil and Chile have the highest number of reported cases so far, with 428 and 342 cases respectively according to WHO’s Pan-American Regional Office. On Friday, Brazilian officials announced a ban on entry of all foreigners from Europe for a month, starting 23 March. On the same day, Argentina, with 128 cases, began a “preventative and compulsory” lockdown. Peruvian president Martín Vizcarra announced an investment of US $28 million to help ramp up diagnostic capacity in the country, which currently has 234 cases and just reported its first death. In one bright spot, Wuhan, the Chinese city at the center of the epidemic merely six weeks ago, reported no new cases of COVID-19 for the first time since the beginning of the outbreak. “Of course, we must exercise caution – the situation can reverse. But the experience of cities and countries that have pushed back this virus give hope and courage to the rest of the world,” said Dr Tedros. “Wuhan provides hope for the rest of the world, that even the most severe situation can be turned around.” Svet Lustig and Zixuan Yang contributed to this story. Image Credits: New York City Nation Guard, Johns Hopkins CSSE. New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
New COVID-19 Diagnostics Offer Hope – But “Broadbased Testing Not Possible” Says Roche Industry Leader 19/03/2020 Elaine Ruth Fletcher & Svĕt Lustig Vijay Covid-19 laboratory test kit (Reverse-Transcriptase Polymerase Chain Reaction) developed by the USA’s Center for Disease Control (CDC) New high-throughput test technologies that can process thousands of COVID-19 samples a day are coming online. But the CEO of Roche Pharmaceuticals, which recently gained US Food and Drug Administration approval for a new high-volume test, asserted Thursday that “broad-based testing is simply not feasible.” Severin Schwan, Roche CEO, was speaking at a press conference of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), where he also serves as vice-president. “Testing is very important to help isolate infected patients, to flatten the curve to help health systems cope with capacity,” Schwan said. “Whilst industry has been ramping up production, still the demand is by far outstripping the supply. Tests should be targeted to patients at risk. Broad-based testing is simply not feasible.” His comments came as countries rushed to obtain COVID-19 diagnostics, while gaps appeared to be widening between different health systems’ abilities to secure and run tests – and not always along the lines of wealthier and poorer countries. The USA, Germany, and Israel, to name some examples have rapidly accelerated mass testing after Korean and Singaporean examples, to head off wider transmission of the virus in line with WHO Director General Dr Tedros Adhanom Gheyebresus’ recommendation Monday to “test, test, test.” But as the number of cases continued to grow throughout Africa and Latin America, health policymakers are increasingly worried about how they could secure tests needed to reduce tranmission to maneagable levels. And in Europe, the new virus epicentre, some of its most affluent nations, including Switzerland which is home to Roche, have said that they are reserving tests for only seriously ill and at risk patients, as a result of the overall shortfall in tests, reagents or other resources. The Canton of Berne was forced to put plans to create a “drive-in” testing sites, imitating a successful Korean model, on hold because of the lack of available tests, Swiss public health officials conceded in a press briefing on Thursday. “There has been an increase in testing, and this has stretched the availability of tests to their limits,” said Daniel Koch, director of communicable diseases in the Swiss Office of Public Health, in a press conference convened by Federal authorities in Switzerland, where 3,888 cases have now been confirmed. Speaking in a televised interview, he added, “Initially you test as broadly as possible. But this phase is over in Europe. It is impossible at the moment to test everyone who might have been infected.” Koch called upon citizens to remain secluded and avoid social contact in order to reduce further transmission, “it’s the last moment. If everyone doesn’t make an effort, we are going to face a catastrophe.” He remarks came against a continued worldwide increase in infections by at least 20,000 new cases overnight, mostly driven by infections in western Europe which is the new epidemic epicentre. Italy was now reporting over 5,000 new cases overnight for a total of 41,035, according to national data. Spain and Germany were reporting over 30,000 cases combined, followed by the United States and France with about 9,415 and 9,058 cases each. The concerns over testing also have been heightened by the recent surge of infections in Latin America (1397), Africa (733), as well as South-East Asia (497) where public health authorities are scrambling to contain outbreaks, and prevent spread in mega-cities. In Lagos, which has so far seen only 8-12 reported cases, Nigerian officials ordered schools closed on Thursday as a pre-emptive move. Global tracking of active cases. Numbers change rapidly. Italy was reporting 41,035, total cases, 5,023 new on other sites. Thermofisher and Roche To Produce Millions of COVID-19 Tests on High Throughput Platforms Recently, the US-based ThermoFisher, one of the largest scientific instrument manufacturers in the world, announced plans to produce up to 5 million testing kits for its Applied Biosystems 7500 Fast Dx Real-time PCR instrument. That represents a more than three-fold increase over the 1.5 million tests currently available on their platforms. “The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement. The Swiss-based Roche also plans to produce millions of diagnostic tests, which run on its Cobas 6800/8800 automated diagnostic systems, following US FDA Emergency authorization of the tests. Globally, Roche has installed some 842 Cobas systems, a Roche spokeswoman told Health Policy Watch. That includes 136 units of the larger Cobas 8800, and 706 units of the smaller COBAS 6800, a Roche spokesperson said. She said that Roche would be partnering with “local affiliates as well as customers, nonprofits, and governments” to harness that testing capacity. The Cobas 8800, Roche’s larger automated diagnostic system, is capable of delivering up to 4128 tests over a period of 24 hours, and 400,000 tests a week. This is ten-times faster than Roche’s existing test, which runs on their MagNA Pure 24 and the LightCycler 480 devices. This suggests that the Cobas 8800 automated diagnostic systems alone could more than double the USA’s current test capacity (of about 182 000 a week), according to a scientific site monitoring COVID-19 test capacity. “We are increasing the speed definitely by a factor of 10”, said Thomas Schinecker, head of the Roche’s diagnostics unit in an interview with Bloomberg News. “Capacity is ramping up as we speak. Millions of tests are available a month but demand is also going up,” added Schwan in the Thursday press briefing. USA doubles testing capacity in five days According to reports by scientists monitoring the landscape, the USA has already doubled its testing capacity over the past five days, largely as a result of expanded use of the so-called “low-throughput” manual diagnostic assays developed by individual hospitals, universities and private laboratories. Once the new high-throughput systems come on line that should expand even more – at least in high income countries. The USA, for instance, currently has 110 COBAS 6800/8800 automated diagnostic systems on hand, according to media reports. Roche does not divulge, however, the global distribution of its equipment, although presumably the automated instruments are primarily available in countries with well-equipped health systems. In low- and middle-income regions, meanwhile, hopes for improving testing capacity may hinge on the development of new rapid, low-cost tests, WHO officials say. In the Africa region, WHO has already distributed some 200,000 test kits, as well as building up laboratory capacity to manage the tests from just two countries, South Africa and Senegal, in early February to 40 countries presently. However, WHO’s Regional Director for Africa, Matshidiso Moeti is anticipating that those initial test stocks could quickly be drained once the virus hits the continent with full-force as it may when the winter season arrives in southern and eastern Africa. “As regards the test kits and the global challenges in their availability, we would like to encourage a very focused screening and case finding strategy where those who have symptoms and their close contacts would be tested,” she said, speaking at a WHO African Region press briefing on COVID-19 Thursday. “We are aware there is a challenge,” she said, adding, “We are very keen to explore test kits and testing approaches that will be carried out in as minimal a demanding a way, and as broadly as possible, so that they can be carried out before or right when people start showing symptoms.” Source: @Covid2019tests Price and Patents Could Create Barriers to Wider Testing – Say Access Advocates Even in well-resourced Europe, however, there are also growing concerns that available diagnostics are too expensive for the volumes now required. This is despite the fact that traditional low-throughput laboratory tests are freely available from public sources since the main patents on reverse-transcriptase Polymerase Chain Reaction (rt-PCR) technology required to conduct the tests have expired, WHO has estimated the cost of those tests as US$ 30-$US60. However, some countries, such as France, also seem to be paying even more. “It is unclear why the set price for a Covid-19 test is 135 Euros, given that the production price is estimated at 12 Euros,” says Pauline Londeix co-founder of the French Observatory for Medicines Transparency in a recent post. “We are asking the [French] Minister of Health …to implement a policy of transparency regarding the price of diagnostics and to regulate them, as was the case with the price of alcoholic gel [hand sanitizer]. Leaders in the diagnostics market exist in France. Their production units must be requisitioned to enable us to produce the tests we urgently need.” In an open letter Thursday evening to French Prime Minister Edouard Philippe, the group further alleged that the current French Health Ministry policies limiting COVID-19 testing to higher risk and more symptomatic cases “contradict” the recent WHO recommendations to test aggressively, and also ignore the examples of Germany and the Republic of Korea which have seen a correlation between widespread testing and reduced COVID-19 mortality. In Thursday’s press conference today, Roche CEO Schwan deferred from discussing the per-unit price of the COBAS tests. But he asserted that expansion of testing infrastructure and lab capacity are the real barriers – not costs. “Cost is not the issue,” said Roche CEO Schwan, “The issue is capacity and access,” he said, “The problem is you need to install highly sophisticated systems in hospitals, you need personnel to ramp up testing. The priority has been to provide those labs with existing infrastructure. These are not tests that you can run at home. We need educated staff for this. “In emerging markets, we have to work with low throughput systems at this stage,” he added, saying. “In parallel, we need to bring additional instruments to labs that have infrastructure where the need is biggest so that we can increase capacity. So cost is not the bottleneck, infrastructure and personnel is the bottleneck.” Still, some access advocates say that without a transparent market in COVID-19 diagnostics – including publicly available data on high- and low-throughput technologies, and their prices, it will be difficult, if not impossible, for global health leaders and national policymakers to rationally plan their strategies, fill stocks and adequately respond to growing demands. “Policymakers should have a clue what it costs to manufacture and deliver diagnostic tests, and by that, I mean, what is the cost to suppliers,” said Knowledge Ecology International’s Jamie Love. “Testing should be done for lots of people and some people will need lots of tests. Prices matter. There needs to be complete transparency of costs and prices for the whole value chain, and this is also consistent with the 2019 World Health Assembly Resolution on transparency. “In an emergency like this, having accurate and relevant information is important. I think everyone knows that, but it is surprisingly how little we know about testing costs right now. For large scale testing, we should see prices between $1 and $5 per test. But we are way off that now. In cases where diagnostics patents have not expired, legal battles could also threaten rapid scale-up of some technologies, observers add. In one such example, Labrador Diagnostics last week filed a lawsuit against BioFire Diagnostics and the French-based BioMerieux S.A. in a US District Court in Delaware for allegedly infringing on its patents linked to its FilmArray System. The BioFire FilmArray Pneumonia Panels System is especially helpful for diagnosing lower respiratory infections, including those created by COVID-19. Should Labrator’s injuction be approved, use of these FDA-approved diagnostics to slow down the outbreak in the USA could be seriously hindered. Image Credits: NIAID-RML, Wikimedia Commons: US CDC, @COVID2019tests. Posts navigation Older postsNewer posts