Carlos Alvarado Quesada, President of Costa Rica

World Health Organization Director General, Dr Tedros Adhanom Ghebreyesus has welcomed the call by Costa Rica’s President, Carlos Alvarado Quesada, for WHO to launch an initiative that would “pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic.”

“I welcome his initiative & call for pooled rights to COVID-19 diagnostics, drugs & vaccines, said the WHO Director General in a reply Thursday on his Twitter account to the presidential overture. “WHO is working closely with governments & agencies around the world to promote rapid R&D. These efforts are rooted in our commitment to equitable access for all.”

Alvarado’s letter, dated Monday 23 and co-signed by Costa Rica’s Health Minister, Daniel Salas, also called for the creation of a “repository of information on diagnostic tests, devices, medication or vaccines, with free access or licensing on reasonable and affordable terms, in all member countries of the Organization,” according to excerpts later posted on the presidential website and Twitter account.

Meanwhile, in another letter to the WHO Director General dated 25 March, the WHO hosted-partnership UNITAID,  offered to work with WHO and the Medicines Patent Pool, a public-private partnership that it founded, to identify “concrete steps to ensure that there will be equitable and timely access to critical health technologies and products for COVID-19 for people anywhere in the world.”

“We appreciate that several initiatives are underway or proposed that seek to address access barriers; this includes but is not limited to the proposal that has been sent to you by the President of Costa Rica about a voluntary pool of patents for COVID-19 related medicines and technology,” the UNITAID letter added.

In his letter, the Costa Rican president further urges the WHO to “develop a memorandum of understanding to share this technology, and to promote its implementation with financial support from the public and private sectors, as well as from international organizations.”

The president also asked WHO’s Global Observatory on Health Research and Development create a database on research and development activities related to COVID-19, including estimates of the costs of clinical trials and subsidies provided by governments and charities.

Extraordinary Virtual Summit of G-20 Leaders Pledges Massive Support for Global Health Response   

Meanwhile, in an Extraordinary G20 Leaders’ Summit on COVID-19, the Group of 20 most industrialized nations issued a far-reaching  set of commitments to fight the pandemic on health, economic and social fronts. Among their key health-related commitments, leaders pledged to protect the most vulnerable as well as safeguarding the global economy; expand manufacturing capacity to ensure medicines and supplies would be available widely at an affordable price; and support WHO and other global health institutions.

“We commit to take all necessary health measures and seek to ensure adequate financing to contain the pandemic and protect people, especially the most vulnerable,” the G-20 statement said at the close of a virtual one-day meeting on Thursday. “We will share timely and transparent information; exchange epidemiological and clinical data; share materials necessary for research and development; and strengthen health systems globally, including through supporting the full implementation of the WHO International Health Regulations (IHR 2005).

“We will expand manufacturing capacity to meet the increasing needs for medical supplies and ensure these are made widely available, at an affordable price, on an equitable basis, where they are most needed and as quickly as possible.”

As for support to WHO and other global health preparedness and R&D efforts, the G-20 statement said: “We will quickly work together and with stakeholders to close the financing gap in the WHO Strategic Preparedness and Response Plan. We further commit to provide immediate resources to the WHO’s COVID-19 Solidarity Response Fund, the Coalition for Epidemic Preparedness and Innovation (CEPI) and Gavi, the Vaccine Alliance, on a voluntary basis. We call upon all countries, international organizations, the private sector, philanthropies, and individuals to contribute to these efforts,”

While acknowledging the need for “urgent short-term actions” to protect front-line health workers, deliver medical supplies, diagnostics tools, medicines and vaccines, the statement also acknowledged that deeper structural changes are needed to bolster health systems, emergency preparedness strategies and spending, as well as related R&D.

“To safeguard the future, we commit to strengthen national, regional, and global capacities to respond to potential infectious disease outbreaks by substantially increasing our epidemic  preparedness spending. This will enhance the protection of everyone, especially vulnerable groups that are disproportionately affected by infectious diseases. We further commit to work together to increase research and development funding for vaccines and medicines, leverage digital technologies, and strengthen scientific international cooperation.

“We will bolster our coordination, including with the private sector, towards rapid development, manufacturing and distribution of diagnostics, antiviral medicines, and vaccines, adhering to the objectives of efficacy, safety, equity, accessibility, and affordability,” the statement added. “We ask the WHO, in cooperation with relevant organizations, to assess gaps in pandemic preparedness and report to a joint meeting of Finance and Health Ministers in the coming months, with a view to establish a global initiative on pandemic preparedness and response. This initiative will capitalize on existing programs to align priorities in global preparedness and act as a universal, efficient, sustained funding and coordination platform to accelerate the development and delivery of vaccines, diagnostics and treatments.”

In his speech at the G20 Extraordinary Leaders’ Summit on COVID-19, Dr. Tedros welcomed G20 leaders promise to “do whatever it takes to overcome the pandemic”.

“This is a global crisis that requires a global response”, he said, adding that leaders need to. “Fight, unite, ignite… with no excuses and no regrets.”

“”No country can solve this crisis alone,” he said, calling upon countries to build upon the solidarity that has so far been expressed, and exhorting them to “ignite a global movement to ensure this never happens again. “

Britain Announces £210 Million to COVID-19 Vaccine Effort 

Also today, the United Kingdom announced that it would provide some $US 254 million (£210 million) in new funding to the Oslo-based Coalition for Epidemic Preparedness Initiative (CEPI) to support the quest for rapid development of a vaccine for COVID-19, in what represents the single largest commitment so far to vaccine research.

CEPI CEO, Richard Hatchett, said the financial support “comes at a pivotal moment for a world that is in crisis. The UK has a long history of global health leadership and, today, the UK is once again stepping up as a global leader in its support CEPI and our crucial work to accelerate the development of a vaccine against COVID-19.”

The UK contribution complements pledges that have already been made by Germany, Norway, Denmark, and Finland, Hatchett said, noting it brings CEPI “closer to the $2 billion we urgently need develop a COVID-19 vaccine and we call on other world leaders to join us in our fight.”

Jeremy Farrar, Director of Wellcome Trust, welcomed the UK government pledge in a statement saying: “Support from enlightened Governments, with commitment to the global research effort is vital if we are to end this pandemic and prevent future tragedies. The pace and impact of the spread of this virus is unprecedented, our global response must be too. The research effort to rapidly advance the vaccines, treatments and diagnostics needed to save lives has been nothing short of staggering. Global support is still, however, falling seriously short – by at least $8 billion in the short-term.

US Appears Set To Overtake Italy as New Epicentre of COVID-19 Emergency 

Active cases around the world as of 2059PM CET 26 March. Right column shows cumulative case count. Numbers are rapidly changing.

The announcement of new investments in emergency response came as the United States appeared set to overtake Italy as the new centre of the COVID-19 pandemic.

There were now 521 086 reported cases of the virus worldwide, nearly 61 000 new cases since yesterday. Of all WHO regions, the European Region continued to experience the largest increase in new cases, with more than 25,000 fresh reports over the past 24 hours, ccording to WHO’s  daily Situation Report, followed by the Americas, with 11,390 new cases, and the Eastern Mediterranean region, with 2,416 new cases. In Europe, Spain is currently experiencing the highest growth in cases, having risen by approximately 10 000 cases since yesterday. In the Eastern Mediterranean region, Iran saw over 2,234 new cases. 

India Converting Railway Coaches to Hospitals 

In South-East Asia, where there were now 2344 cases, and Africa, which now had 1664 confirmed reports, government leaders were moving evermore aggressively on pre-emptive measures – while facing large, looming gaps in available hospital beds, medical supplies and services.

On Wednesday, India began a 21-day, nationwide lockdown along with announcing a massive aid bill to support its citizens during the closure. The bill aims to provide rice/lentils for ~60% of the country’s 1.3 billion people.  “No doubt this lockdown will entail an economic cost for the country, but saving the life of each and every Indian is the first priority for me,” said the Indian Prime Minister Narendra Modi, “If we are not able to manage the next 21 days, then many families will be destroyed forever. 

Mathematical modelling suggests that 300 million Indians could become infected by COVID-19, of which about four to five million could be severe, said Dr Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy, in an interview with the BBC. 

India’s dense population, which is one of the main drivers for India’s high predictions,  has not made it easy – Last wednesday, the first case of COVID-19 was reported in a slum of Mumbai inhabiting over 23,000 people in less than a square kilometre of land. Contact tracing has proved particularly difficult. 

In an attempt to alleviate an overwhelming shortage of beds in India and to prepare for a growth in COVID-19 cases, India was looking to convert its trains into hospitals.

Given that railway services in India have been suspended and the ready availability of 12 617 trains, with 24-30 coaches in each train, 10 million beds can be created “within no time”, said Sunil Kumar V, Managing Director of Asset Homes to to the Prime Minister and the authorities of the National Disaster Management Authority.

As of last Sunday, Indian National Railways had begun moving coaches to their home zones so as to prepare them for disinfection and quarantine facilities.  Meanwhile, the Indian government has said that all scheduled international commercial passenger flight services would remain closed till April 14th. 

Four fifths of countries in Africa are not Adequately Prepared for COVID-19

WHO Regional Director for Africa, Matshidiso Moeti, meanwhile said that local virus transmission still was not widespread on the continent, but time was running out to prepare.

“We still have a window of time that is narrowing. In about half of countries, we still only have imported cases. We have not yet identified that local spread is occuring,” she said, speaking at a World Economic Forum webinar on Thursday. 

She said that the draconian border closures that have been undertaken now in many African nations need to be accompanied by stronger public health interventions, including more systematic identification of cases, follow-up of contacts, and isolation of cases and contacts, as needed.

While some countries like Spain have already recommended the anti-malarial chloroquine to treat COVID-19 as part of their national outbreak response, Africa is “waiting to get robust data [from the WHO’s multi-country clinical trials] to make recommendations [about using chloroquine], said Michel Yao, Emergency Operations Programme Manager at the WHO’s Regional Office in Africa. 

“If clinical trials show the potential of the drug, we should use it. We will not recommend it formally before its impact and side effects are properly measured”, he said in the webinar. 

Only about a fifth of African countries (8/47) are adequately prepared to response, according to a WHO African Region Readiness Response Sheet. These include Algeria, Ghana, Cameroon, Kenya, Tanzania, Madagascar and Ethiopia. Another 33 countries are moderately prepared, while 7/47 countries have limited readiness status, including Benin, Namibia, Guinea Bissau and Gambia.

Among the issues identified, the assessment found that:

  • Only a quarter of African countries have full access to PCR test materials for the SARS-Cov-2 virus;  while 39/48 countries have the capacity to detect viral pathogens using an open-PCR platform, only 12/48 have access to primers (probes) specifically designed to detect SARS-Cov-2 using PCR assays.
  • Only 7/48 African countries have benefited from health worker training on Covid-19 (Angola, Botswana, Eswatini, Ethiopia, Ghana, Lesotho, Seychelles), and only 4/44 countries have districts with health facilities that benefited from training on detection and reporting on Covid-19. These include Seychelles (100), Lesotho (70), Zanzibar (36), Liberia (4);
  • There are only 9 countries in the whole African continent that have more than 50 facilities with nCoV case definition and surveillance tools, including: Algeria (100), Capo Verde (100), Cote D’ivoire (100), Mauritius (100), Seychelles (100), Togo (100), Rwanda (100) Senegal (54), Gambia(51);

However, African countries seemed better prepared in terms of biosafety, the assessment found. Some 45 countries out of 48 had stocks of personal protective equipment (PPE), although only about 30 countries have sufficient PPE for medical staff for case management and screening procedures. Some 44/48 countries reported that air and transport distribution systems are available in the country to restock supplies. 

-Svet Lustig, Tsering Llhamo and Zixuan Yang contributed to this story.


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Medellin, Colombia’s Parque de las Luces stands empty on bank holiday after city and regional leaders call on the population to stay indoors due to COVID-19 threat.

In normal times, Diego Zapata, undersecretary in the City of Medellin’s Mobility Department, worries about how to advance better public transit systems, cycling and pedestrian networks – to get more people moving around the city.

But recently, he and his boss Carlos Cadena began supporting the City’s Health Department in its scramble to reduce travel around the city – and scale up capacity to rapidly diagnose new COVID-19 cases so that Colombia’s second largest city can head off a wider, and more devastating outbreak of the novel coronavirus. 

The disease is just now beginning to gain a foothold in Latin America and Africa.  As of Tuesday, some 52 people in the Medellin metropolitan region and 378 Colombians nationally had been reported ill. 

Just a week ago, tests for COVID-19 could only be done in the national laboratory in Bogota, leading to considerable delays and limiting local test capacity. But on Friday, a breakthrough occurred – the Antioquia Regional Laboratory in Medellin also began conducting tests, after training staff and securing precious reagents. 

“There is an urgent need to improve regional and local testing capacity to try to contain the pandemic”, says Zapata last week, in an interview with Health Policy Watch. As a clean air and mobility advocate, he has been particularly worried that Medellin’s population, includes many older people and migrants, who have suffered a period of chronic exposure to heavy air pollution emitted by forest fires in Colombia’s northern region, could be particularly vulnerable to the impacts of the virus on respiratory health.

Diego Zapata at work in normal times promoting clean, sustainable transport for Medellin, Colombia.

Such concerns reflect the “whole of government” approach that some lesser-affected cities and regions in Africa and Latin America are now putting in place to get ahead of the virus wave, as well as the steady global uptake of a key message issued by WHO’s Director General Dr Tedros Adhanom Ghebreyesus, who told the world last week that expanded use of diagnostics is key to fighting the outbreak: 

“Test, test, test. You cannot fight a fire blindfolded. And we cannot stop this pandemic if we don’t know who is infected,” said Dr Tedros.   

That message was underlined again on Sunday by WHO’s Emergency Head Mike Ryan. He told the BBC’s Andrew Marr that the lockdown measures being widely used in Europe and elsewhere are not enough on their own to solve the crisis. Such restrictions in Asia only succeeded because they were also accompanied by rigorous testing – “once we’ve suppressed the transmission, we have to go after the virus,” he said.   

Indeed, while some countries and cities have appeared almost lethargic about testing, other countries, regions and cities are racing to find new and creative ways to activate testing and other local measures, with any available resources.  

The challenges and opportunities cut across economic and geographic fault lines – from high-income Europe, the new virus epicentre, to North America and low- and middle-income countries of Africa and Latin America. Regional and local laboratories like Medellin’s, which sprawls across a metropolitan area of nearly 4 million people, are gearing up, and new rapid tests are just coming online, offering hope that more and more cities and regions in low- and middle-income areas can accelerate testing capacity.  

Early on in the epidemic, however, Asia created some good practice examples for how diagnostics can be wielded to stem the tide of new cases – in the context of broader public health strategies. And Africa is eyeing the development of rapid COVID-19 test technologies – which have contributed so much in turning the tide on infectious diseases such as malaria and HIV/AIDs.    

Health Policy Watch (HPW) looks at the diagnostics landscape through the lens of these Asian stories of success, as well as the promising new innovations such as rapid diagnostics now on the horizon – while recognizing that there is no “one-size-fits all” approach.  

(HPW/Svet Lustig): How countries rank in COVID-19 tests/per million population. Developed from national test data collected by FIND (finddx.org) as of 24 March, 2020.

The Republic of Korea: Tested Like Mad – No Nationwide Lockdown Imposed 

Any story on diagnostics has to begin with the Republic of Korea, founder of the now legendary “drive-in” test sites, and the country outside of China with the largest COVID-19 test capacity in the world – with 6,471 people tested per million, or about 15,000 tests per day. 

Korea’s decisive measures centered on widespread testing, transparency and education have helped slow down the outbreak and minimize panic amongst civilians.

Schools and kindergartens closed, and mass events were cancelled. The southeastern cities of Cheongdo and Daegu, and parts of North Gyeongsang province as “special disaster zones”. But thanks to its aggressive testing and contact tracing early on, Korea largely avoided the kinds of massive commercial shutdowns and widespread restrictions on individual movement that are now being seen in Europe and North America.  

(HPW/Svet Lustig): COVID-19 test trends in selected low- and middle-income countries of WHO’s Western Pacific (WPRO), Eastern Mediterranean (EMRO) and Americas (AMRO) regions. Developed from national test data collected by FIND (finddx.org) as of 24 March, 2020.

 

(HPW/Svet Lustig): COVID-19 test trends in selected countries of WHO’s European Region. Developed from national test data collected by FIND (finddx.org) as of 24 March, 2020.

The integrated strategy also helped keep mortality rates down. Death due to Covid-19 in Korea have so far been three times less than the global average

“It’s much better to test and then quarantine a specific person than to do a city-wide or province-wide lockdown, which in certain ways prevents the virus from leaving the province but actually doesn’t make the province any less likely to have high infection rates,” says Dr.Eric Feigl-Ding, a senior fellow at the Federation of American Scientists in Washington, D.C., and an epidemiologist at the Harvard Chan School of Public Health.

A Network Approach to Laboratory Response

With the memories of the 2015 outbreak of Middle-East Respiratory Syndrome (MERS), which killed some 38 Koreans, fresh in mind, the country already had undertaken key reforms to allow quick approval of new diagnostics during emergencies, maintain local production capacity, and link public and private labs together in a national network. 

This allowed Korean manufacturers to design and create a COVID-19 test, as well as get a network of 96 labs across the country to work on manufacturing and using it, within 17 days, Professor Gye Cheol Kwon, the chairman of the Laboratory Medicine Foundation, told the BBC. The organized network function also helped avoid the inconsistencies in test quality, production rates and distribution, seen in other countries.

Inspectors visit a drive-in COVID-19 test site in Busan, Republic of Korea

Test Strategy Cast a Dragnet

With plenty of tests available across the country, thanks to the well-organized laboratory network, Korea focused its very first rounds of testing around the contacts of the first clusters of COVID-19 infections emerging among travelers returning from abroad as well testing all 210,000 members of the cult-like Shincheonji church in the southeastern city of Daegu as well as North Gyeongsang province, where the first virus clusters had emerged. 

Much broader criteria were soon adopted; these enabled anyone with a simple doctor’s note to get a free test. Those lacking a note could still get a test for US$130. Any subsequent  hospitalization and treatment were also offered for free – further incentivizing people to get the tests without fear of debilitating health care costs. This contrasts sharply with the approaches that are now being taken in some European countries, such as France and Switzerland, where decisions on testing remain in the hands of health care providers and only people deemed to be highly symptomatic or at high risk are allowed to be tested at all.  

A hallmark of Korea’s Covid-19 response has been their drive-thru testing centres. The procedure takes approximately 10 minutes, and is able to test 10 people per hour, which is twice as fast as diagnosis in an indoor clinic. Briefly, drivers are asked to answer a short questionnaire, their temperature is taken and they are swabbed inside their nose. This approach has been shown to be convenient and safe, especially for front-line workers and patients in waiting rooms, limiting the potential for the virus to spread. 

In densely populated city centers, where vehicles are less common, Korea also implemented mobile testing stations and staged home visits, which allowed for the identification of positive cases within hours. 

Testing Part of Integrated Strategy 

The government has also promoted social distancing, encouraging the roll-out of church services online in the devout population. The government also invested heavily in digital and social media outreach, including personalized mobile phone messages complementing 2x daily public press briefings. 

Creative uses of digital technologies also played a role. The government used private civilian phone data to anonymously track positive cases by GPS location. Applications, such as Corona100m, also used such publicly-available data to help civilians avoid high-risk areas linked to the Covid-19 outbreak in a user-friendly fashion, even as they moved about freely, in most cases. 

Via Corona100m, users received phone alerts if their proximity to any recorded case was less than 100 meters. The phone app was downloaded 1 million times within 10 days of its launch. Although the information is ‘anonymized’, concerns also arose, however, about privacy infringements.  

Instead of shutting down airports completely, Korea last week adopted additional screening and mandatory quarantine measures, for all Koreans as well as foreign nationals into the country.  This also helped mitigate Covid’s impacts on the economy. 

From its precarious ranking as the largest cluster of cases outside China in mid February, Korea this week had 5884 active cases, and was reporting only about 94 new cases a day on average, last week.

“We must maintain this trend. We have come this far thanks to the citizens who were united and cooperated well with the government. But it’s too early to be optimistic. Please be a little bit more patient and stay away from mass gatherings such as religious events. Moon Jae-in, Korea’s president, told The Guardian recently.

“South Korea showed to the world that it can allow curtailing a pandemic with limited infringements to individual freedom and disruption to the economy and the fabric of society,” Dr. Balloux wrote.

Singapore: Public Health Preparedness Clinics Take Load Off Mainstream Health Services 

Singapore light rail lines continued to operate at height of COVID-19 emergency. Source: Jade Lee.

Singapore was one of the first countries outside of China to be hit by Covid-19, and had the highest number of cases outside of China for almost two weeks in February 2020 (05/02/2020-18/02/2020). It’s successes in “flattening the curve” since have made it the country with the slowest Covid-19 growth rates in the world (doubling time of 7 days).  

“Test, test test”  was also a cornerstone of the city-state’s policy from the beginning – including broad criteria for who should get a test, free testing, and diligent tracing of contacts of confirmed cases.  

While Korea created drive-in test sites, a hallmark of Singapore’s outbreak response was the re-activation of its Pandemic Preparedness Clinics, used in the H1N1 flu era and in air pollution haze events, to administer tests and provide follow-up. 

Rebranded as “Public Health Preparedness Clinics,” the 900 PHPCs offer COVID-19 tests to the public in venues separated from mainstream health services, protecting patients and health workers alike. 

The Ministry of Health recommends any patient with respiratory symptoms, fever, cough, sore throat and runny nose seek help at PHCPs, which are mandated to not only test, but also dispense initial treatments, and conduct follow-up investigations. As an additional precaution to ensure that no potential case remained unidentified, Singapore’s health authorities also mandated private doctors to test any patient with flu or pneumonia-like symptoms. 

Ramping up Local Diagnostics Capacity .

Even before COVID-19 first hit Singapore on February 23 2020, diagnostics were also widely accessible. Within a week of Covid-19’s sequencing by Chinese scientists (12 January 2020), the Multi-Ministry Taskforce coordinating COVID-19 response had done the necessary legwork to organize local manufacture of large quantities of diagnostic tests.

As of 25 March, the widely available and free testing (with a doctor’s note) had helped identify a total of 8930 close contacts of known virus cases. All such contacts, as well as travelers arriving from elsewhere, are quarantined for 14 days. Of the contacts, 6287 have completed their quarantine and 2643 are still under quarantine. But other Singaporeans can move about freely.  An antibody blood test was also used to help investigators track down the source of the original large outbreak, which was linked to a church group, STAT News reported.  

Modest (yet effective) Social Distancing measures 

Dorcson alert levels. Source: Singapore Ministry of Health.

While Singapore has social distancing measures, the approach stands in stark contrast to the much stricter measures adopted in Europe or the ‘shelter-in place’ orders in USA hotspots. 

Schools remain open, although children’s temperatures are screened prior to entry. Singapore reduced the scale of public events to below 250 participants, which is still far less restrictive than recent measures seen in Europe. To protect the elderly, all “senior-centric activities” are suspended until the beginning of April.

While the Ministry of Health has previously said that risks to the public “from transient contact, such as in public places, is low,” last week it issued stricter advice to reduce frequency of get-togethers and socializing. 

“Social responsibility is a critical factor in slowing the transmission of the virus. We need all Singaporeans to play their part in the fight against COVID-19…This means reducing the frequency of [get-togethers], and minimising physical contact with one another. Those who are unwell, even with mild flu-like symptoms, should see a doctor and stay at home to prevent spreading illness to others.”, stated the Ministry of Health of Singapore in a press release.

Singaporeans have expressed strong support for the government’s early and aggressive testing measures. 

Full faith in the medical personnel of Singapore,” wrote one Singaporean, Joyce Chan, who went to the doctor for a simple cough and wound up getting a COVID-19 test.  

“With such dedicated medical professionals and good systems and processes in place, I have full confidence that Singapore can handle this situation well. Now, more than ever, is the time to seek treatment if you are feeling unwell (instead of potentially passing any virus on to others)….The experience gave me 100% confidence in Singapore’s preparedness to contain and deal with the current #Covid19 situation”, said Chan, who agreed to be quoted by Health Policy Watch.

SARS was a Template for Singapore Response 

The residual traumas of the SARS epidemic of 2003, as well as the H1N1 crisis of 2009, were etched into collective memories and that helped spur Sinaporeans to rapid, collective action, observes local journalist Jade Lee. 

“Singapore was hit by SARS in 2003, and that gave Singapore a template for response,” she said. “It was the lived experience that made Singapore much more cautious early on. We had the advantage of moving fast and aggressively against the virus from the beginning.”

Efficient governance also helps. 

Singapore is a good example of an all-of-government approach – Prime Minister Lee Hsien Loong’s regular videos are helping to explain the risks and reassure people”, said  Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization in a press briefing on Covid-19.

As Dale Fisher, professor at the National University of Singapore, noted in an interview with The Guardian: “We [Singapore] don’t do anything different, we just do it well.”

Gearing Up in Africa – GeneXpert and Rapid Diagnostic Tests  

A scientist at Ethiopia’s National Influenza and Arbovirus Laboratory, equipped to test for COVID-19.

Right after an international public health emergency was declared, WHO launched a massive drive to equip African health systems, deemed to be the most vulnerable,  with tools to test and treat patients.  

In early February, WHO shipped over 200,000 tests to 47 countries across the continent and trained national labs or central hospitals in 40 countries to process test results. 

Paradoxically, the virus headed north instead, over ever widening swathes of Asia, Europe, The Middle East, and North America, while Africa was largely spared. 

Now, however, as Africa begins to see its first real wave of cases, those initial tests are rapidly being used up, notes Owen Kaluwa, WHO Representative for South Africa, which received just 2,500. 

“There were 200,000 kits for the 47 countries that our offices are covering,” he said at a WHO Africa Region Office press briefing last week. “This is what they started with and what they are using now, most are requesting replenishment, as they are seeing increasing numbers of cases. 

In light of the greater infectious potential of the virus, and sheer numbers of people becoming ill elsewhere, African health authorities are hoping to see the expedited development of rapid diagnostics tests – which played such a large role in combating other diseases like HIV/AIDs and malaria.  

Speaking at the press briefing on 19 March, Matshidiso Moeti, WHO Regional Director for Africa, said that African nations want tolearn from the experiences of other countries which have seen a sharp decline in COVID-19 cases through rapidly scaling up testing, isolating cases and meticulously tracking contacts.”

Owen Kaluwa, WHO/South Africa (left); Dr. Matshidiso Moeti, WHO Africa Regional Director (center)

But she added that Africa would need more low-cost and rapid test solutions to be effective. 

“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, and that would allow us to initiate the measures around social distancing, hygiene, isolation that are so important,” Moeti said.

“We are aware that there is a challenge. But we are very keen to explore test kits and testing approaches that will be carried out in a minimally demanding way, and as broadly as possible, before or right when people start showing symptoms”, Moeti said.

According to FIND, the Geneva-based non-profit public-private diagnostics partnership, there are already nearly 100 some rapid tests, mainly antibody blood tests, already commercialized in China and the Republic of Korea, and elsewhere in Asia. 

In the USA, the first antibody blood test, developed by Mount Sinai’s Icahn School of Medicine, was now due to be piloted soon in the USA COVID-19 epicentre of New York City. The test can also identify who has been exposed to the virus and may be immune or asymptomatic. 

The US FDA has agreed that body-fluid tests can be marketed with an abridged process of agency review. 

Other such tests are also under development in Europe, North America and elsewhere. But none so far have received a WHO, European or US regulatory seal of approval to a level that would pave the way for bulk, donor-funded purchases and use in clinics and field settings, such as Africa. 

The UK-based firm, Mologic, however, hopes to be one of the first approved for the African market. It has announced plans to roll out a rapid test being developed in a collaboration with Senegal’s Institut Pasteur de Dakar as early as April.  The test is to be manufactured in Senegal by the pharma company DiaTropix, with prototypes to be ready in mid-April, according to the manager of DiaTropix, Cheikh Tidiane Diagne. 

Mologic has received £1 million to develop the test as part of the UK government’s £46 million international coronavirus (COVID-19) prevention and research funding package, and the aim is to manufacture the test for as little as £1.

While targeting Africa first, high-income countries swamped with Covid-19 cases will also benefit from the emergence of new rapid tests, said Mologic Medical Director Joe Fitchett, in the company’s press release.    

“The COVID-19 outbreak is at a critical juncture, and to bring it to an end, we need next- generation diagnostics for use at the point-of-need – at home or in the community, in limited and well-resourced settings,” he said. 

(HPW/Svet Lustig): COVID-19 test trends in selected high-income countries of WHO’s Americas (AMRO), African and South East Asia (EMRO) regions. Developed from national test data collected by FIND (finddx.org) as of 24 March, 2020.

Meanwhile, the worldwide network of some 10,000 GeneXpert® diagnostics – traditionally used to test for TB – may provide Africa and other low- and middle-income countries with another important interim solution.  A new COVID-19 test for the GeneXpert platform was just approved last week by the US FDA, and medicines access advocates are now calling for the test price to be reduce from $US 20 to $US 5 for the 145 low- and middle-income countries that procure GeneXpert tests at concessionary prices, under arrangements with donors and international agencies such as WHO and the The Global Fund to Fight AIDS, Tuberculosis and Malaria. 

“The GeneXpert® platform could fill a crucial need, especially in low- and middle-income countries,” Paula Fujwara, Scientific Director of the International Union Against Tuberculosis and Lung Disease (The Union), told Health Policy Watch on Monday. “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 could be “easily and rapidly done,” since the technology is already well-known.

Colombia: Ramping up Tests and Social Distancing Measures 

Medellin, Colombia’s second largest city

As of 18 March, fewer than 3,000 tests had been performed in Medellin; six days later the national number had grown to 7240 tests – with 378 cases confirmed. The largest case cluster was in the capital city of Bogota, while 52 cases have now been reported in Medellin, Colombia’s second largest city. 

In a comment to Health Policy Watch, Antioquia’s Secretary of Health, Luis Gonzalo Morales said, “We have test capacity at our regional laboratory in Antioquia to undertake the tests. Early this week we have begun the process. We have sufficient reagents to undertake the quantity of tests necessary based on the criteria that has been set by the Ministry of Health.” 

Zapata also credits the Antioquia regional governor, Anibal Gaviria, and Medellin Mayor Daniel Quintero, with strengthening policies on social distancing, which left streets in the city largely deserted over the recent bank holiday – as well as clearing the skies of persistent air pollution. Schools have been closed since mid-March, and public gatherings have been limited. 

Still, Medellin remains vulnerable to the COVID-19 pandemic given its high population density, as well as the scarcity of hospital beds, says Zapata. For instance, it has only 850 beds equipped with respirators for the city of 2.4 million people. Furthermore, 11.4% of Medellin’s population is above the age of 65, amounting to at least 250 000 elderly at risk, Zapata stresses. 

Nationwide, Colombia has only 1.7 regular hospital beds per 1000 people, according to official Health Ministry data, as compared to Cuba (5.1 beds), Uruguay (2.7) or Panama (2.3).

Venezuelan migrants flock to city hall, creating COVID-19 transmission risks, after fake news report of emergency financial handout circulate on social media.

Fake News Can Lead To More Infections 

More than a quarter of Colombia’s population is living below the poverty line. And in Medellin, especially, large migrant population of Venezuelan migrants remain vulnerable, including to misinformation. 

A recent fake WhatsApp message sent hordes of Medellin migrants running to the Municipality headquarters thinking that they would get a handout of money due to the COVID emergency.  Also, Medellin continues to face chronically high levels of air pollution due to forest fires burning in the north, notes Zapata.

Still, Zapata is hopeful that the recent pre-emptive measures, along with stepped up testing, are now having an impact. There are fewer people on the streets and in the buses.  And more than 100 technology volunteers working with a local non-profit initiative, #InnspiraMED, which has created three prototype mechanical ventilators from open-source technologies. The initiative aims to bring the prototypes to scale locally, as well as generating models that can be copied elsewhere around the world. 

Meanwhile, Zapata is now working from home along with his boss, Medellin Mobility Secretary, Carlos Cadena, directing  essential daily operations of traffic workers and contractors. Zapata is happy that at least air pollution had been reduced somewhat, as a result of the lighter traffic in the city. 

Cadena recently tested positive himself for COVID-19, trying to plan ways to reduce traffic and rationalize public transport flows, in ways that also reduce commuters’ infection risks. As a close contact, Zapata was tested — and is still awaiting results. 

Cadena, who shot an upbeat video message from isolation at home after being diagnosed, with a picture of a bicycle in the background, continues to work from home, while recovering. 

“He is ill, but he has remained on the front lines,” says Zapata. 

Carlos Cadena, Mobility Secretary, Medellin: will keep working from home, while recovering from COVID-19.

Image Credits: Diego Zapata , Busan Metropolitan City, Jade Lee, Singapore Ministry of Health, WHO AFRO/Otto B., HPW, Carlos Cadena.

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.

Carlos Alvarado Quesada, President of Costa Rica

Costa Rica’s president, Carlos Alvarado Quesada has appealed to Dr Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, to “pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic”.

The presidential letter dated Monday, 23 March, and co-signed by Minister of Health, Daniel Salas Peraza, proposed that the global pool “should include existing and future rights in patented inventions and designs, as well as rights in regulatory test data, know- how, cell lines, copyrights and blueprints for manufacturing diagnostic tests, devices, drugs, or vaccines”.

“It should provide for free access or licensing on reasonable and affordable terms, in every member country.”

In the letter, first published by the advocacy group, Knowledge Ecology International, Costa Rica also echoed an earlier request by Chile for the WHO’s Global Observatory to compile a comprehensive database to document all R&D activity related to COVID-19 with clinical trial cost estimates, and the subsidies provided by governments and charities.

“Improving transparency through the Global Observatory on Health R&D, as mandated in the resolution, would allow us to better understand the costs of developing these technologies and what roles are being played by each actor” ,said Luis Villaroel, Director of Corporación Innovarte in Chile, an advocacy group, in a statement.

Compulsory licenses that override existing or future patents on promising COVID-19 treatments have been approved or are under consideration by a growing number of nations, including Costa Rica, Chile, Colombia, Peru, Malaysia, the Netherlands and Israel, to enable their citizens to gain access to patented medical products related to Covid-19 at an affordable price.

Last Friday, a resolution to issue compulsory licenses was approved by a committee in Ecuador’s National Assembly. 

“If in situations like the current one, the intellectual property system cannot provide solutions for the benefit of the population, we should necessarily rethink the model”, said Hernan Nuney, the executive director of the Ecuadorian Institute for Intellectual Property to Knowledge Ecology International, an advocacy group focused on patent and medicine issues.

Under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization (WTO), a country can approve a compulsory licence to a generic drug maker or public agency to enable a patented medicine to be produced without the brand-name company’s consent. In other words, a compulsory licence can suspend a monopoly run on a patent, enabling others than the patent holder to manufacture and to supply the product.

Last week, US drugmaker AbbVie waived worldwide restrictions on its Lopinavir/Ritonaivr HIV combination drug, marketed under the brand name Kaletra, which is now being studied as a treatment for COVID-19.

“Given this important public health crisis, AbbVie commits that we will take all steps necessary to remove any potential barriers to alternate sources of supply, including dedicating to the public our intellectual property related to lopinavir/ritonavir”, said an AbbVie spokeswoman.

Abbvie represents the first large drugmaker to have prioritized provision of the medicine around the world over potential financial gains from potential COVID-19 treatments. Kaletra had patent protection until at least 2026 in certain regions, according to MedsPaL, a medecines patents and licenses database. 

However, a study of 199 hospitalized patients published in the New England Journal of Medicine found that the lopinavir/ritonavir combiation only led to a median 1 day improvement in patients’ outcomes over the standard of care, leading authors to conclude that there was essentially “no benefit” of the treatment over standard of care, although they said that future trials in patients with severe illness would still be needed to exclude or confirm the drug’s potential.   

The findings, were “not unexpected” because these antiretroviral drugs [lopinavir/ritonavir] are not at all targeted to coronavirus proteins – this was always something of a long shot”, said one Derek Lower in a blog in Science Translational Medicine.  Even so, a day later, Israel approved the issuance of a compulsory license for generic versions of the drug should it be needed for COVID-19 treatment, saying that the decision to override the patent rights still in force locally until 2024 was justified insofar as the Kaletra formulation is currently unavailable. 

“The company with the patent and official importer in Israel are not able to supply the necessary inventory for this drug,” said the Justice Ministry in a statement explaining the decision. “The state will be able to import generic substitutes from countries where the patent has expired.”

Despite AbbVie’s subsequent decision to waive patent rights, the Israeli move was regarded as an important precedent among medicines access advocates, which noted that Israel is a member of the Organisation of Economic Development and Co-Operation (OECD), and OECD member states rarely override patent rules.  

A comprehensive list of therapies for Covid-19 can be found here. While many are already existing drugs that are being tested for efficacy against the SARS-CoV2 virus, there are also some two dozen new therapeutics in the pipeline as well as over 60 COVID-19 vaccine candidates. 

Some of the top candidates are the focus of a WHO-organized SOLIDARITY trial, which was announced last week, as an umbrella effort to bring disparate clinical trials together.  These top candidates include remdesivir, originally developed by Gilead Pharmaceuticals as a treatment for Ebola, for which it failed to show results. But in the case of COVID-19, there have been scattered observational reports showing improvement, and it is currently the focus of at least five separate clinical trials. A third leading candidate is the antimalarial drug hydroxychloroquine, in combination with the antibiotic, azithromycin.  Initial, positive results from a small French trial were reported late last week, involving a total of 42 patients, 26 of whom received the experimental drug combination, with a significant reduction in viral loads amongst 20 patients who received the full course of treatment.  

Rush For Treatments Comes Against Rising Cases in Europe, Americas, Africa & South-East Asia 

The rush to find treatments came against the sharp rise of cases seen worldwide almost everywhere outside of western Asia, and now approaching half a million mark.

The biggest new regional uptick was now being seen in Latin America and the Caribbean, where some 5317 cases had been recorded as of the 24th of March, along with 57 deaths. Brazil and Chile accounted for the most cases with 1857 and 733 people affected. Argentina, Bolivia, the Brazilian state of São Paulo and Colombia have introduced obligatory nationwide (or statewide) quarantine while others have curfews in place. Meanwhile, Brazil and Uruguay have sealed their border to prevent incoming visitors to Brazil. 

As the coronavirus spreads in Brazil and Colombia, indigenous tribes are closing off their reserves to visitors. Though no cases have been confirmed yet among the indigenous populations, tribes that have limited interaction with outsiders have historically experienced low immunity against respiratory diseases in general. Therefore, “with the coronavirus threat, there is the possibility of really exterminating an entire people”, warns Paula Vargas, Brazil program manager for Amazon Watch, an indigenous rights group. 

Regionally, Africa was also showing a significant increase in transmission, with 1396 confirmed cases in 43 countries. Egypt, South Africa and Algeria have the highest number of cases with 294, 274 and 201 infections respectively. 

In Italy, 5,246 new cases had been reported over the past 24 hours. However, for the third day running, new cases remained below the peak of 6,600 new cases on Saturday 21 March, leaving some hopes that trends might be steadying out in the country of 60 million people that has experienced almost as many cases as in China’s population of 1.4 billion. Per capita, Switzerland’s cases were closely following those of Italy, with about 900 infections per million people, according to the latest data, although some of the increase could be attributed to more extensive testing than elsewhere in Europe. Switzerland has recently tightened its border controls, and was ramping up other response measures.

Global tracking of active cases of COVID-19 (middle) around the world as of 19:31 PM CET 24 March. Numbers change rapidly.

France Access Group Protests Health Ministry Inertia on COVID-19 Testing  

In neighboring France, Minister of Health, Oliver Veran, came under fire on Monday after saying that France would not undertake massive testing for COVID-19 until the current lockdown was over, and newer rapid tests, as well as blood tests to identify people that have antibodies to the virus were developed.

In a press statement, the French Observatory for Medicines Transparency, denounced Veran’s policy as contradicting WHO.

“The WHO has not said ‘wait for serological tests’, the WHO has said ‘test, test, test,’ protested Pauline Londeix, co-founder of the group. 

“Widescale testing would help identify COVID-19 in groups such as health workers, cleaners, and store clerks, who might have light or asymptomatic cases but could potentially infect many others if they were not identified, allowing them to isolate themselves, recover and protect others,” she said.

“The more days that pass, the more it appears clear to us that pseudo-medical decisions have been taken by the [French] government concerning COVID-19 testing, due to economic considerations, first and foremost.  Our country, one of the seven largest industrial powers in the world, and supposedly blessed with an important biomedical industrial sector, is continually out of step, and constantly being forced to improvise”, Londeix added.

She said the government should elaborate a clear test strategy and ramp up national public production of test kits, including reagents and their raw materials, as well as alcoholic gel and protective masks for health workers as soon as possible. 

Although patents on most of the standard, low-throughput PCR technologies, the letter also expressed concerns that control over high-volume diagnostic test tools remains concentrated in the hands of a few key pharma and diagnostic test manufacturers, such as Roche, Abottt/Alere, Biomérieux, Quiagen and Thermo Fisher, who hold the rights to their respective test platforms. 

Gauri Saxena contributed to this story 

Image Credits: Johns Hopkins CSSE.

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.

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:

  1. Increase production of protective equipment;
  2. Support cross-border mobility and lift export restrictions on protective equipment;
  3. 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.

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.