An N95 respirator, used during the COVID-19 pandemic to protect healthcare workers against infection

Dutch Deputy Prime Minister Hugo de Jonge on Wednesday offered to support the World Health Organization to develop a pool of intellectual property rights for COVID-19 technologies, just days after WHO Director-General Dr Tedros Adhanom Ghebreyesus announced WHO’s public support for the initiative.

“In principle, I am sympathetic to this initiative,” Minister de Jonge wrote in an update on the Netherlands’ COVID-19 response on Tuesday. “The development of this initiative in relation to the availability and affordability of vaccines must take place in the coming period.”

This makes the Netherlands the latest country to back a call by Costa Rica to establish a freely accessible pool of rights for tools to fight the pandemic. Rights holders would voluntarily contribute IP rights on any data, treatments, diagnostics, vaccines, or COVID-19 technologies to the pool, which would then be made available to a number of manufacturers to quickly scale up production and access to such tools.

These rights “must be made available to everyone for free, or for a reasonable license fee,” said de Jonge.

Dr Tedros first publicly announced WHO’s commitment to the Costa Rica proposal on Monday, adding that WHO was currently working with Costa Rica to “finalize the details.”

The Board of UN-backed Medicines Patent Pool, which manages a “pool” of patent rights for essential medicines, announced its support for the COVID-19 IP pool last week, temporarily expanding its mandate outside of medicines and treatments.

Kentucky Governor Requests 3M Release N95 Patent

Kentucky Governor Andy Beshear called on the United States-based company 3M to release its patents for N95 respirators – a type of protective mask in desperately short supply during the COVID-19 pandemic.

“The procurement is incredibly difficult, as is the manufacture because it’s under patent,” Beshear said in a press conference on 1 April. He added that it was the company’s “patriotic duty” to license the N95 patents “to the nation” during the pandemic so that “everybody else can manufacture it.”

While 3M is not the only producer of N95s, it is the largest domestic producer. The company holds 441 patents in the US that mention ‘N95’ or ‘respirator,’ according to a list from James Love, director of Knowledge Ecology International, a patent watchdog group. The newest respirator-related patent granted to 3M was approved just yesterday, on 7 April 2020.

The respirators are used by healthcare workers in order to protect against the virus, and offer much better protection than surgical masks. However, due to the extreme shortage of respirators around the world, most hospitals in the US are running low or completely out of the protective masks. Many have resorted to rationing the N95s to one per physician every two to three days, or collecting and sanitizing them after use. Under normal circumstances, N95s are discarded after each use.

Beshear’s comments come just on the wake of US President Donald Trump’s invocation of the ‘Defense Production Act,’ a Korean War era law that allows the federal government to redirect domestic industries’ capacities towards wartime production.

See The Courier Journal for more on this story.

Image Credits: OSHA's Respiratory Protection Standard 29 CFR 1910.134.

Community health worker distributes Mectizan (ivermectin) to eliminate river blindness

While much of the public fanfare around new COVID-19 drugs has centered around the lupus drug, hydroxychloroquine, and a failed Ebola remedy, remdesivir, other researchers are keen to explore the potential of other time-worn remedies – although here, too, experts are urging extreme caution.   

Ivermectin, the antiparasitic drug that turned the tide in the West African fight against river blindness (onchocerciasis) some 30 years ago has been found to slow the growth in the laboratory of SARS-CoV-2, the virus behind COVID-19. Meanwhile, a widely circulated preprint study claiming that countries with mandatory Bacillus Calmette-Guérin (BCG) vaccination against tuberculosis may experience lower rates of COVID-19 cases and deaths has led to the initiation of at least two clinical trials on the prophylactic use of BCG in Australia and the Netherlands, with more countries planning on follow suit.

Still, the concentrations of ivermectin that were demonstrated as effective against SARS-CoV-2 in the laboratory cell culture experiments are “far beyond” dosage levels approved by the FDA to safely treat river blindness in humans, warned the Mectizan Donation Program, in an Expert Committee Statement, issued on Tuesday. High doses of ivermectin have shown “serious toxicity” in animal studies, they added.

In the laboratory trial, the single dose of ivermectin [Mectizan®] slashed the growth of SARS-CoV-2 by 5000-times within 48 hours, reported the study published in Antiviral Research last Friday. 

Clinical trials would be needed to determine if there is a dose of ivermectin that is both safe for humans and effective against the SARS-CoV-2, and even expedited human safety trials can take time, a WHO scientist told Health Policy Watch. 

“There is a long path from showing something works at certain concentrations in [cell culture studies] on the virus to showing that the required concentrations can be achieved in the target tissues in humans and are expected to be safe for humans,”  said the scientist.

Then, the drug would also have to be studied further in randomized controlled studies in COVID-19 patients, and must be proven to demonstrate “clinical benefit,” added the scientist. 

Millions of doses of the FDA-approved medication are donated every year to oncho-endemic countries through the Mectizan Donation Programme created by Merck Sharpe & Dohme (MSD), which developed the drug in collaboration with the TDR, the WHO-hosted Special Programme for Research and Training in Tropical Diseases, in the late 1970s. Ivermectin is typically administered once a year in communities of West Africa where onchocerciasis is endemic, to prevent the development of the disease, which can lead to blindness when it goes untreated. 

BCG Clinical Trials Beginning in Australia and Netherlands  – But Researchers Warn Against Complacency in Countries Where Vaccine is Widely Used 

Similarly, researchers have questioned the validity of the BCG vaccine study, urging for more robust studies on the effectiveness of the vaccine.

The initial pre-print study by researchers at the New York Institute of Technology found that in 28 middle- and high-income countries, which did not require BCG vaccination, there were also higher numbers of COVID-19 cases per capita and higher death rates than in countries that enforced universal BCG vaccination. BCG is a vaccine typically given to infants, which protects against tuberculosis in young children, although protection wanes by age 12. The vaccine has been demonstrated to induce a more general immune response, which may offer protection against other respiratory diseases. The study was published on the preprint server MedRxiv in mid-March, which means that it has not yet been peer-reviewed.

“Accepting these findings at face value has the potential for complacency in response to the pandemic, particularly in low- and middle-income countries [where BCG vaccination is highly prevalent]” warned infectious disease researchers Emily Maclean, Lena Faust, Sophie Huddart, and Anita Svadzian of McGill’s International TB Centre in Canada, in a searing critique published in Nature Microbiology Community. 

“The pre-print’s study design, timing of analysis and data collection, lack of adjustment for important confounders, and uncertain biological plausibility mean that we cannot view the paper’s findings as causal,”  Maclean told Health Policy Watch. 

Rather, she said, this type of ecological study, which only observes broad population level data, should be “hypothesis generating”. Under normal circumstances, such a study would spark more epidemiological studies and early phase clinical trials to test the vaccines’ safety and efficacy.

“However, given that we’re in extraordinary times, I think following up on promising vaccine leads is a good choice,” said Maclean, particularly because scientists already know the long-established vaccine is “safe for use” to humans.

“Ethically- and properly-conducted randomized control trials will allow us to see if BCG has a causal effect regarding COVID-19 morbidity and mortality,” she added. 

That’s exactly the step that some countries are taking. Phase III clinical trials to test the BCG vaccine in healthcare workers have begun in the Netherlands and in Australia, and researchers in the United States are also exploring ways to begin trials. The Inserm Research Director at the Institut Pasteur in Lille France, Camille Locht, is preparing for the implementation of a double-blind clinical trial in collaboration with Spain. 

Still, the vaccine is not a “panacea” warned Nigel Curtis, coordinator of the clinical trial in Australia, to the the New York Times. Both the Australian and the Dutch trials will aim to only assess whether the vaccine would reduce the duration of illness, thus allowing sick healthcare workers to recover more rapidly and return to work.

Japanese BCG vaccination kit

WHO Africa Region Hits 10,000 Cases

The WHO Africa region, which encompasses most of Sub-Saharan and Southern Africa, hit a sober new mark on Tuesday when the region surpassed 10,000 cases.

“COVID-19 has the potential not only to cause thousands of deaths, but to also unleash economic and social devastation. Its spread beyond major cities means the opening of a new front in our fight against this virus,” said WHO Regional Director for Africa Matshidiso Moeti in a press release.

Moeti urged for a “decentralized response” tailored to the local context across the continent. “Communities need to be empowered, and provincial and district levels of government need to ensure they have the resources and expertise to respond to outbreaks locally,” she added.

Of particular concern are countries with fragile health systems experiencing complex emergencies – some countries in Africa do not have the hospital bed capacity, enough ventilators, and trained personnel to take care of a surge of patients.

“Africa still has an opportunity to reduce and slow down disease transmission.  All countries must rapidly accelerate and scale up a comprehensive response to the pandemic, including an appropriate combination of proven public health and physical distancing measures,” said Ahmed Al-Mandhari, WHO’s Regional Director for the Eastern Mediterranean, which includes North African countries such as Egypt, Morocco, and Tunisia.

South Africa, with 1,749 cases and 13 deaths, has the highest number of cases, but the death rate so far is highest in Algeria with 205 deaths and 1,572 cases.

Total cases of COVID-19 as of 7:30PM CET 8 April 2020, with active case distribution globally. Numbers change rapidly.

Image Credits: Mectizan Donation Programme, Y Tambe, Johns Hopkins CSSE.

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.

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 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.

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.

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.

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.

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.

 

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.”

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.