Dr Tedros speaks at the 27 April WHO COVID-19 press briefing

When the World Health Organization sounded the alarm by declaring a ‘public health emergency of international concern‘ on 30 January, “the world should have listened,” said WHO Director General Dr Tedros Adhanom Ghebreyesus, in his strongest response to date, to repeated allegations by the United States that WHO failed to act quickly enough in the early days of the coronavirus pandemic.

“The world should have listened to WHO carefully then, because the highest level of global emergency was triggered. This was on January 30 when we only had 82 cases and no deaths in the rest of the world,” said Dr Tedros, repeating even more adamantly messages he delivered on several occasions last week, “We advised the whole world to implement a comprehensive public health approach; find, test, and do contact tracing.

“You can take for yourselves countries who followed [our advice] are in a better position than others. This is fact,” he added.

Although the Director-General refrained from pointing fingers at specific nations, his response was clearly aimed at  US President Donald Trump, who bitterly attacked the agency for allegedly being China-centric and failing to provide sufficiently early warnings, and then suspended nearly US$ 500 million in funding – which represents some 15-20 percent of the WHO’s 2020-2021 budget. The US has now become the new epicentre of the COVID-19 pandemic – after Trump initially downplayed the risks posed by the virus and even praised China’s management.

“We don’t have any mandate to force countries to implement what we advise them,” Dr Tedros said. “WHO gives the best advice we can based on science and evidence, and it’s up to the countries to reject or accept.

“But what we have seen so far is that some countries accept [our advice] and some may not. At the end of the day, each country takes its own responsibility.”

Some 75% Of All COVID-19 Deaths Reported in Just Six Countries – Led by United States
United States tops the list of six countries with the most COVID-19 fatalities. (University of Oxford, CEBM). Orange bar indicates initial dates of state lockdowns.

In fact, some 75% of all COVID-19 deaths were reported in only 6 countries – with the United States at the top of the charts – a new analysis from researchers at the University of Oxford found. 

As of 24 April, there had been some 54,941 deaths in The United States, which suffered the biggest toll,  followed by Italy, Spain, France, the United Kingdom, and Belgium. 

These six countries together accounted for 155,457 of the 206,008 global deaths reported in the period – although they comprise only 7.5% of the global population. The sobering numbers come even as countries are slowly easing lockdown measures as new infections decrease, hoping that they have weathered the peak of the epidemic. 

New Drug Trial Results Sparks Hopes for Tocilizumab Therapy; Outcomes for Hydroxycholorquine and Remdesivir Less Positive 
How Tocilizumab may calm the “cytokine storm” provoked by immune overreaction to COVID-19

An antibody therapy used to treat inflammatory conditions associated with rheumatoid arthritis – tocilizumab – showed promising results in small, preliminary trials on COVID-19 patients in France, researchers at the Assistance publique – Hôpitaux de Paris, reported on Monday.

Given the pandemic context, “the investigators and sponsor felt ethically obligated to disclose this information,” said the investigators in a press release from the Assistance publique – Hôpitaux de Paris.

“These results should be confirmed independently by additional trials,” said a statement from the hospital press release, which was initial posted and then blocked, after having been widely reported in French media. 

The drug, produced by Roche Pharmaceuticals, is rapidly gaining attention as a potential COVID-19 therapeutic, with another Phase III clinical trial, approved by the US Food and Drug Administration, underway in the United States.

In the French trial, a 14 day course of tocilizumab was found to significantly reduce the proportion of moderate or severe COVID-19 patients who required more intensive ventilator support, or died.  

The drug works by preventing IL-6 cytokines from binding to immune cell receptors. In many severe COVID-19 cases, an overreaction of the immune system to the SARS-CoV-2 virus unleashes a wave of cytokines and immune cells, causing massive damage to the lungs that can lead to acute respiratory failure. Some scientists have posited that blocking the so-called “cytokine storm” could prevent massive lung damage. 

The trial observed 129 patients with moderate or severe COVID-19 in a multicenter randomized control trial conducted across several French hospitals. The specifics of the study will be submitted to a peer review journal pending longer follow-up in the patients.

The new US FDA-approved study on tocilizumab will enroll 330 patients in a randomized controlled trial run by Roche, the company that produces the drug, and the US government entity, Biomedical Advanced Research and Development Authority (BARDA), a branch of the US Health and Human Services Department.

Meanwhile, new results on hydroxychloroquine and remdesivir, two of the therapeutics tapped for the World Health Organization’s Global Solidarity Trial, have not so far made strong showings, in the preliminary results of human trials which have recently been reported – although these studies also have have significant limitations. 

Preliminary results of a small remdesivir study in China, accidentally posted by the World Health Organization last week, showed no significant differences in mortality after 28 days of treatment, among patients who received the drug and those who did not. In a screenshot captured by STAT News, the trial results also reported that 11.6% of the patients who had received remdesivir also stopped the drug early due to adverse effects. The trial results were quickly removed from the Clinical Trials Registry site, with WHO saying that the results were not yet conclusive. 

Screenshot of WHO Clinical Trial Registry capturing remdesivir trial results, captured by STAT News

In a statement released on Thursday, Merdad Parsey, chief medical officer of Gilead said the trial had been terminated, but expressed hopes that other studies might yield a more positive picture: “The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusion,”  Parsey said.  He claimed that “trends in the data” could indicate that remdesivir may have clinical benefit when given to patients in earlier phases of the disease.

In early February, remdesivir showed promising results against the COVID-19 virus, SARS-CoV-2, in a Chinese cell culture study. However, these results have not been replicated in human studies.

As for hydroxychloroquine, a number of recent studies and warnings have emerged to the effect that the high doses required to combat the virus may also prove fatal to some patients.  Those include a study in Brazil, which was terminated early due to adverse effects.

Last Thursday, a retrospective analysis of outcomes among some 368 US patients treated with the drug, or with the drug in combination with azithromycin,  found “no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19.”  The study of patients treated in US Veterans Health Administration medical centres, also found an association of increased overall mortality in patients treated with hydroxychloroquine alone.

At the same time, researchers have not given up on the drug. A 400-person Phase III Clinical trial was announced last week by Swiss authorities for the hydroxychloroquine as well as the HIV drug lopinavir/ritonavir. The trial is to be run by the Geneva University Hospitals, Basel University Hospital and the Swiss Tropical and Public Health Institute. There are currently over 60 clinical trials of various drug combinations underway in Switzerland.

Global Trends

Switzerland began today its first phase of a three-stage re-opening. Hospitals resumed all medical procedures, including elective surgeries. Caps on funerals, which were restricted only to close family members, were lifted. Businesses offering low levels of direct contact, such as hairdressing salons, massage practices, tattoo and cosmetic studios, florists, garden centres, and DIY stores, were reopened. 

Similarly New Zealand’s Prime Minister Jacinda Arden, who has been praised for her handling of the pandemic, announced Monday that the country was deescalating from a level four to level three emergency as new infections dropped into the single digits.

Yesterday, the Italian Prime Minister Giuseppe Conte announced that the country will deescalate into phase two. From May 4th, businesses such as catering services, manufacturing, construction, real estate, wholesale trade, and sports activities can resume operations. An additional $55 billion is pledged to support families, workers, and businesses struggling due to the pandemic. 

Meanwhile a new Swiss biosensor could be used to detect the COVID-19 virus, SARS-CoV-2, in public spaces like hospitals or train stations, Swiss authorities reported last Thursday. The biosensor, which was developed by the Swiss Federal Laboratories for Materials Science and Technology (EMPA) in collaboration with Zurich’s Federal Institute of Technology (ETHZ), can help contain outbreaks in public spaces by detecting ‘hotspots’ of viral genetic material floating in the air.

In the United States, the nursing home industry sought immunity from lawsuits after lawmakers  appealed to the CDC and CMS to disclose information on infections in nursing home facilities. Nursing homes have emerged as outbreak hotspots in most hard-hit countries. Hans Kluge, Regional Director for WHO Europe, told reporters last Thursday that almost half of the COVID-19 deaths across the WHO European region were in nursing homes.

In an interview with Financial Times, Bill Gates announced that the Bill and Melinda Gates Foundation (BGMF) would “almost entirely shift” to work on COVID-19 related problems, even in the non-health sectors such as education, where the Foundation has become involved in online learning.

Meanwhile, the CDC added six more symptoms to COVID-19, including chills, repeated shaking with chills, new loss of taste or smell, sore throat, headache, and muscle pain. 

In a video conference today with the Chief Ministers of the Indian states, Prime Minister Narendra Modi claimed that ‘the lockdown has yielded positive results’ and that ‘the country has managed to save thousands of lives in the past 1.5 months.’ 

Modi’s remarks coincide with the Indian Ministry of Health and Family Welfare’s new guidelines for home isolation of very mild/pre-symptomatic COVID-19 cases released today. The recommendations include mandating that caregivers and patients wear a triple-layered medical mask and disinfecting the used marks with 1% sodium hypo-chlorite solution before discarding.

Total cases of COVID-19 as of 6:31PM CET 27 April 2020, with active case distribution globally. COVID-19 cases exceed 3 million mark.

Tsering Lhamo and Svet Lustig Vijay contributed to this story.

Image Credits: University of Oxford/CEBM , Journal of Translational Medicine, WHO Clinical Trials Registry, captured by STAT News.

Soweto, South Africa. Poverty and crowded conditions make lockdowns doubly difficult.

As the COVID-19 pandemic unfolds, it continues to reveal and reinforce deep inequalities within and between countries, where low income and marginalized populations pay the highest price and suffer the most.

On Tuesday 28 April, a Panel discussion on ‘COVID-19 And Global Inequality’ will zoom into the issues even more deeply, with featured speakers including Winnie Biyanyima, executive director of UNAIDS, Mandeep Dhaliwal, of the UN Development Programme (UNDP), as well as voices from academia and civil society. The event is being hosted by the New-York based Julien J.Studley Graduate Program in International Affairs, in collaboration with Health Policy Watch.

The event, at 3 p.m. GMT time (11 EDT/17 CET), is the first in a series on Global Pandemics in an Unequal World webinar, which will address how public policymakers and civil society can change the dominant discourse of many policy debates by prioritizing health, sustainability and egalitarianism.

“Inqualities are deeply driven by the entrenched structures of health systems and the global economy. And after this pandemic is over, these are likely to be even more riveted onto the social fabric of societies – unless we get the right policies in place,” said Sakiko Fukuda-Parr, Professor and Program Director of International Affairs at the New School in New York, who will moderate the webinar. The series will continue over the summer, looking at other themes related to COVID-19 and health inequalities.  

Along with Biyanyima, and Dhalilwal, director of HIV/AIDS and human rights at UNDP, Tuesday’s panel will also include:

  • Nicoletta Dentico, journalist and director of the Global Health Program at the Society for International Development (SID) and;
  • Manjari Mahajan, associate professor of international affairs & Starr professor and co-director of the India China Institute at The New School

Link here to register for the event. Follow the livestream here:

Image Credits: Matt-80.

Sky clears up in New Delhi, India.

“I am not celebrating the fact that people can see the Himalayas or that the air quality is better in Madrid coming out of this virus, but what might come out of it is an awareness of how much human beings have contributed to the ongoing damage to people’s lungs, to our ability to drink clean water, to the harmful algae blooms in the Great Lakes, to the hurricanes and intense storms in the Midwest. Maybe it’ll be a wake-up call,” – Gina McCarthy, president and CEO of the Natural Resources Defense Counsel (NRDC) and former US Environmental Protection Agency Administrator.

As skies clear and waterways clean up due to widely adopted lockdowns and quarantines all over the world, three prominent environmental health scientists and policy experts, Maria Neira, the World Health Organization’s Director of Environment, Climate Change and Health; Gina McCarthy, administrator of the US Environmental Protection Agency under Barack Obama; and Aaron Bernstein, Director of the Center for Climate Health and Global Environment at the Harvard T. Chan School of Public Health, explored how environmentally unsustainable policies have predisposed vulnerable communities to COVID-19, at a webinar hosted by Harvard University last Monday in recognition of Earth Day.

Air pollution, mainly due to fossil fuel burning, makes people more vulnerable to serious illness from respiratory infections. In the case of COVID-19, emerging evidence is also revealing far higher death rates among people infected with COVID-19 and living in highly polluted cities. 

As economies start to open up, the experts urged governments to take time to rethink their priorities and offered a roadmap to invest in more sustainable transport, energy and urban policies that would make societies healthier as well as more resilient. 

“We have to use [the pandemic] to create a healthier society better prepared for emergencies, no doubt, more investment on our epidemic preparedness and response capacities at all levels,” said Maria Neira.

Maria Neira, WHO Director of Environment, Climate Change and Health

The pandemic has also underlined how both health, climate and environmental hazards in one part of the world can affect people on the other side of the planet, said Bernstein, a paediatrician by training.  

He described how he visited a family’s home, fully suited in protective gear, to examine a child suspected of being infected in the early days of the US epidemic. 

“As I walked into the room, dressed in my alien suit, and touched that child’s hand through the barrier of a synthetic rubber glove. It occurred to me – that child’s hand could connect me to a bat living in Asia. By the way, I work in Boston.” 

In looking forward into the future, the panelists emphasized that this pandemic, despite its devastation, does present a ‘shock’ that could change our economic system. Here, the Bernstein emphasized a transition into a green economy, and considered the present inequities between not just the global South and the global North, but within countries where the poor and marginalized often share an unequal burden of disease. 

“We cannot get out of this crisis at the same level of environmental pollution that we went in. Even before the crisis we were having 7 million primitive deaths caused by air pollution and we were very much vulnerable today. Our health was very vulnerable to climate change and the responses we need to provide are more important than ever,” said WHO’s Maria Neira.

Boys play on a beach in Kiribati, an island nation threatened by rising sea levels due to climate change.

As part of a Health Policy Watch’s continued coverage on COVID-19 and climate, here are some key excepts from the Q&A:

Air Pollution Predisposes Vulnerable People to Negative COVID-19 Outcomes

Q – Is there a link between air pollution and the severity of coronavirus? Do most polluted cities experience more severe coronavirus epidemics?

Aaron Bernstein – “For every small increment in air pollution [in long-term studies], there’s a substantial increase in death from COVID-19…This kind of air pollution makes people more vulnerable to respiratory infections and makes them more likely to die. You could pick any city in the world and expect to see an effect of air pollution on people’s risk of getting sicker with coronavirus.”

Maria Neira – “The evidence we have is pretty clear. And on top of that, of course, within those cities [that are more polluted], the people who are most at risk are people who are already sick, people who are poor, and in the United States, the evidence is strongly suggesting minority communities of color.”

Gina McCarthy – “We have to look at low income [groups] and we have to look at people of color, who are in this COVID-19 exposure. Actually, we’re seeing African Americans die at much higher rates than others in part because of their exposure to air pollution…they are already predisposed [due to high air pollution levels]; this is adding another layer of burden on their bodies. And they just can’t fight equally.” 

 Q – Considering that the southern hemisphere is moving towards winter shortly, could a colder climate be expected to increase the transmission of COVID-19 and /or its lethality? And if so, what would be the recommendation to scientists and policymakers?

Aaron Bernstein – “We don’t have clarity about what temperature means for the virus. It’s been thriving and warmer temperatures and colder temperatures as it is. And so I think the best thing we need to do is to have surveillance in place and the ability to test people at a broader scale as possible. And particularly in many cases among the poor.”

Aaron Bernstein, Director of the Center for Climate Health and Global Environment at the Harvard T. Chan School of Public Health

Addressing Climate Change To Better Mitigate Public Health Crises – A Holistic Approach Is Key

Q – If the coronavirus shows how effectively we can mobilize to confront a public health crisis, what does framing climate change as a public health crisis look like? 

Gina McCarthy – “We have to figure out how we can live healthy lives. We know now that we have a problem, not just with our ability to treat, but with our ability to prevent and that needs to be invested in. We have to get people to understand that…if you invest in stopping people from getting sick, which is what all environmental protection is about, then you save enormous money in lives, from having to spend the money to treat them on the back end.”  

Maria Neira – “Climate change is creating the conditions for the population to be extremely vulnerable and we cannot leave this crisis by not joining forces between all the efforts: the law, the legislation, the enforcement, the demands by the environment community and [through community mobilization]…We need to prove to the population that this is not a completed agenda….Our lungs have been made very vulnerable by the levels of exposure to pollution that we had for many years.” 

The COVID-19 Pandemic: A Strategic Opportunity To Promote A Green Recovery

Although it is “very difficult” for humans to learn lessons from the past, Maria Neira is “very optimistic” that the “new society” can do the right thing.

Q – How should countries limit air pollution to reduce the impact of coronavirus?

Maria Neira – “We need to avoid the temptation [of going back to] intensive use of fossil fuels or again intensive use of traffic, private cars, or going back to activities that will be considered as important to recover the economy…It has to be a green recovery, it has to be an investment, this time on maintaining the commitments for tackling climate change, on moving into a green and renewables and stopping the use of fossil fuels, and working as well on healthy cities, better urban planning and in the mobility of the new society….One of the most important benefits of this type of healthy planning on this new transition will be by the reduction of air pollution. So, this will require a lot of work from the scientific community, from the climate change, air pollution, energy, and sustainable development community, a community. We need to have a common narrative. We need to be very strategic.”

Q – What steps should governments take to reduce air pollution and prevent future pandemics like COVID-19? 

Gina McCarthy – “My biggest concern has been the stimulus dollars [to address the economic effects of the pandemic in the USA]. How you spend this money is going to be usually important. We know climate change and the challenges we face on air pollution are going to cost money, but they are also going to prevent public health damages, and we have to invest in a better future, and not go backwards.”

Gina McCarthy, president and CEO of the Natural Resources Defense Counsel (NRDC) and former US Environmental Protection Agency Administrator.

Investment in Education, Science and Prevention: An Awakening For Governments ?

Q – Clearly, climate friendly policies can provide long term improvements to public health, but what would you say to local officials and governors coming out of COVID-19, what should be the first priority of local official and governance? Where should the priorities be in the first 12 to 24 months to address both COVID-19 and climate change?

Gina McCarthy – “[Governments] need to make science-based decisions, and they need to look at what healthy air and clean water looks like. And they need to use the laws that are in the books and create more to make sure that we’re protected.”

Maria Neira – “One of the lessons of this horrible shock is that the investment on the health systems, investment on education, investment on researchers and scientists is definitely a non-regrets investment. I mean having a very strong health system, well prepared to respond to this type of public health crisis has proved to be fundamental…This crisis is once again demonstrating how much the government needs to take the right decisions to protect people’s health…[we need to] invest in primary prevention [and build] a very good health system, trying to reduce as much as possible those horrible inequalities that are bad for the population, for the health of the people, but they’re very, very bad for the economy of the country as well.”

This story was published as part of Covering Climate Now, a global collaboration of more than 250 news outlets to strengthen coverage of the climate story, co-founded by The Nation and Columbia Journalism Review.

Image Credits: Maria Neira, WHO.

Ursula von der Leyen, European Commission President, speaking at the virtual launch of the Access to COVID-19 Tools (ACT) Accelerator virtual launch

In the largest global collaboration to address the COVID-19 crisis so far, the World Health Organization, European Commission, and other partners including the Bill and Melinda Gates Foundation (BMGF), launched a new campaign to accelerate development of COVID-19 diagnostics, drugs, and vaccines – and just as critically ensure that they are affordable and accessible worldwide.

The European Commission will be hosting a rolling pledging campaign, beginning 4 May, to raise the 7.5 billion Euros to bankroll the massive effort, said Ursula von der Leyen, EC President.

In a striking display of multi-lateral unity, launch of the new ‘Access to COVID-19 Tools’ (ACT) Accelerator was made in a WHO public webcast featuring UN Secretary General Antonio Guterres, Melinda Gates, 11 heads of state, including Germany’s Angela Merkel, France’s Emmanuel Macron, and South Africa’s Cyril Ramaphosa, as well as other leaders across Africa, Asia, and the Americas, and Europe.  

Strikingly absent were the United States and China, which have been locked in bitter dispute with each other over the management of the COVID-19 crisis. But Macron specifically addressed the political tensions, saying he hoped to “be able to reconcile this initiative” with both superpowers.

“I hope that both of these countries will be able to fight against COVID-19 by developing vaccines together,” said Macron. “There should not be any divisions between countries, we need to join forces.” Clinical trials for five of the seven leading vaccine candidates identified by the WHO are being conducted in either the United States or China. 

“Human health is the quintessential global public good, and today we face a global public enemy like no other. COVID-19 requires the most massive public health efforts,”  said Guterres in prepared remarks. “For too long we have undervalued, underinvested in global public goods. Data must be shared, production capacity prepared, resources mobilized, and politics set aside.”

UN Secretary-General Antonio Guterres calls into the ‘Access to COVID-19 Tools’ (ACT) Accelerator launch event.

“The ACT Accelerator brings together the combined power of several organizations to work with speed and scale,” added WHO Director-General Dr Tedros Adhanom Ghebreyesus at a 90 minute virtual launch, co-hosted with French President Emmanuel Macron and the BMGF. “Each of us are doing great work, but we cannot work alone. We’re coming together to work in new ways to identify challenges and solutions.” 

Leaders of other global health organizations echoed Guterres’ and Tedros’ calls urging countries to collaborate in the pandemic response.

Melinda Gates, co-founder of the BMGF, said “COVID-19 knowns no borders, and defeating it will require action across sectors and countries.”

“Beating coronavirus will require sustained actions on many fronts,” said von der Leyen, president of the European Commission. “This is a first step, only, but more will be needed in the future.” 

Search for a Vaccine Dominates

As new COVID-19 cases continue to rise in newly affected hotspots, and some states begin to weigh the risks of a resurgence as cases plateau, there was wide agreement among the leaders that developing and deploying an effective COVID-19 vaccine was the priority. Von der Leyen and Chancellor of Germany Angela Merkel called for such a vaccine to be treated as “a universal public good.”

Hope of curbing the pandemic was pinned on a vaccine just as early COVID-19 drug trial results, revealed that remdesivir, the most promising therapeutic so far, may not be as effective as initially suspected. The pre-print study was accidentally posted by WHO and obtained by STAT News.

“COVID-19 is not a human endemic infection, this will not disappear. The only true exit strategy is science,” said Jeremy Farrar, director of the Wellcome Trust.

“Finding and distributing the vaccine is the only way to win this battle,” said Guiseppe Conte, president of the Council of Ministers of Italy. “The role of governments is to promote good governance, transparency, and mutual accountability to ensure universal, equitable access to the vaccines.”

Guiseppe Conte, president of Council of Ministers of Italy, speaking at a virtual ACT Accelerator launch

So far, vaccine developers have reported that an acceleration of funding is required to bring candidates through later clinical trials and market approval. The Coalition for Pandemic Preparedness and Innovation (CEPI), which has been supporting three of the six vaccine candidates that have entered clinical trials around the world, is still facing a US $1 billion shortfall to bring a successful vaccine candidate to market.

“The establishment of the ACT Accelerator is a watershed moment in the world coming together to develop a global exit strategy from the COVID-19 pandemic,”  said Richard Hatchett, CEPI CEO. “Everyone must have access to the tools and countermeasures, including vaccines, that we will develop through the Accelerator.”

Hatchett’s comments were echoed by several heads of state and leaders of global health organizations from around the world, who stressed the importance of making any new COVID-19 tools accessible in an equitable way.

“We must commit to a system of clear global access goals as long as the virus is active somewhere. We are all at risk. The fight against COVID-19 must leave no one behind,” said Prime Minister of Norway, Erna Solberg.

Erna Solberg, PM of Norway, speaking at a virtual ACT Accelerator launch

But while the search for a vaccine dominated the discussion, other speakers reaffirmed the importance of supporting a holistic COVID-19 response, focusing on providing equitable access to diagnostics, therapeutics, and strengthening the public health system for future pandemic threats. The standing president of the G20 group of most called pandemic preparedness the “smartest investment for us to make today.”

“We might face a similar threat in the future,” said G20 president and Minister of Finance of Saudi Arabia, Mohammed bin Abdullah Al-Jadaan. “In order to deal with future pandemics effectively, we have to invest in strengthening our preparedness  and response systems. G20 is working with relevant organizations to assess that gaps with the view to establish a global mechanism for response.”

Key Commitments Under the ACT Accelerator

Under the ACT Accelerator, 11 major global health agencies, organizations, and pharma industry representatives made five major commitments in a statement released Friday:

  1. Aim to ensure equitable global access to innovative tools for COVID-19 for all;
  2. Commit to an unprecedented level of partnership to proactively engaging stakeholders and existing collaborations to align and coordinate efforts;
  3. Commit to create a strong unified voice to maximize impact;
  4. Build on past experiences towards achieving this objective;
  5. Stay accountable to the world, to communities, and to one another.

Some 11 heads of state including the United Kingdom’s first Secretary of State Dominic Raab, Spain’s President Pedro Sánchez Pérez-Castejón, Chairperson of the African Union Commission Moussa Faki Mahamat, Malaysian Prime Minister Muhyiddin Mohd Yassin, and Rwanda President Paul Kagame, among others spoke at the launch event to support the collaboration. Costa Rica President Carlos Quesada Alvarado, who called on WHO to create an accessible pool of COVID-19 intellectual property rights, also called in to support the launch. 

The initial group of collaborators includes the Bill & Melinda Gates Foundation (BMGF); the Coalition for Epidemic Preparedness and Innovations (CEPI), Gavi, the Vaccines Alliance; the Global Fund for HIV/AIDs, Tuberculosis and Malaria; UNITAID; the International Red Cross and Red Crescent Movement, and the Wellcome Trust.

Pharma industry representatives including the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA); the Developing Countries Vaccine Manufacturers’ Network (DCVMN); and the International Generic and Biosimilar Medicines Association (IGBA) have also joined as founding members of the Accelerator.

The World Health Assembly in Geneva, Switzerland.

In the wake of the COVID-19 pandemic, there could be “a window of opportunity… that would be suicidal to miss” to revise the International Health Regulations that govern countries’ behaviour during health emergencies, said Gian Luca Burci, former World Health Organization head legal counsel and now professor of international law, at a panel hosted by the Geneva Graduate Institute and Global Health Centre.

The present system may have led to delays in ramping up levels of alert at key points in the crisis to an international health emergency, Burci suggested at Tuesday’s panel entitled “What’s law got to do with COVID-19.”

“The system of alert right now is either we have an emergency or we have nothing. There is a growing consensus [that this system must be replaced by] something much more incremental,” Burci said.

The International Health Regulations (IHR), the legal framework for WHO’s emergency coordination and countries’ response, also has a “very weak” system for commanding sovereign states’ compliance with its provisions to prevent, prepare and respond to infectious disease outbreaks, Burci underlined.

But it remains up to Member States of the World Health Assembly to decide whether the WHO should wield more power, said Steven Solomon, principal legal officer for governing bodies at the World Health Organization.

As the only binding international law that governs international and member state response, and last updated in 2005 under very different global conditions, it is time for IHR to be revised, agreed Solomon and Gian Luca Burci. The question is how? 

The World Needs The WHO For Leadership And Coordination 
Top: Steve Solomon, current WHO Principal Legal Officer.
Bottom: Gian Luca Burci Former WHO Principal Legal Officer and Professor of International Law.

“To respond with two words, what can be done now [by WHO within the IHR system]…is leadership and coordination”, said Solomon.

Yet despite WHO’s attempts to coordinate such outbreak response for the world, countries have not always complied.

Export restrictions, which can block critical supply chains for essential products like personal protective equipment or medicines, have been adopted by 28 countries despite WHO guidance that such barriers impede efficient emergency allocation of resources, said Sueri Moon, Co-Director of the Geneva-based Global Health Centre.

“While many recommendations by the WHO have been implemented at the national level,” said Burci, the same level of adherence has not been observed in the international arena, with regards to trade, travel and related areas, “and we have to wonder why,” said Burci.

Countries have not complied because they simply do not have the incentive to do so under the current IHR rules, he added. 

“The system of accountability is weak. States can do whatever they want, without much accountability and with impunity,” Burci said. “There is resistance [by the WHO] to naming and shaming. There is no system of assessment of compliance [decreasing incentive for members to comply]”, he added.

Needed: “Agile” System For Resolving Trade Desputes

To address some of the trade barriers that have emerged during the emergency, the IHR would also requrie an ‘agile’ mechanism for settling trade disputes. The current system is “very weak”, and with countries shutting down their exports in a desperate attempt to prioritize sovereign supply, such revisions have become more important than ever. 

“There is no system of dispute settlement. The one we have is very weak. Look at what’s happening now, with border closures and trade limitations. These are the seeds of major dispute…There are evident gaps in travel restriction and trade restriction policies,” said Burci. 

At the broader level, a stronger compliance assessment system, integrated into the IHR, could make Member States more likely to comply with WHO recommendations because their responses to outbreaks would be evaluated and communicated to the public, agreed Solomon and Burci.

Public scrutiny, or ‘naming and shaming’, could be a useful tool to improve the WHO’s capacity to lead and coordinate an effective response at an international level.

An enforcement compliance mechanism can be created if Member States were interested in creating one, suggested Solomon. The WHO would also be ready to support countries if they decided on a new Mandate for that within the IHR context.

“Member states or countries decide…[if] something needs to be changed; that’s certainly an area where WHO would support, but that mandate has to come from Member States. That mandate can only be provided from the countries themselves,” he said.

The IHR revisions mentioned by Solomon and Burci, ranging from a compliance assessment to an improved trade dispute resolution mechanism, are not, however, compatible with the current architecture of WHO financing.  When most of its budget is controlled by a handful of large stakeholders, WHO’s hands are often tied in terms of inspecting, auditing or compelling countries to adopt emergency measures. 

Legal Experts Call For Sustainable WHO Financing Mechanism 

Top contributors to WHO’s Budget (2018)

Funding was dramatically highlighted last week when US President Donald Trump decided to suspend US funding, which amounts to about 15% of WHO’s annual budget. In addition, the regular annual “assessed” contributions of member states comprise only about one-fifth of the total WHO budget, while the rest comes from national “voluntary” commitments, which may be short-lived and are often earmarked for specific purposes.  

Solomon and Burci advised Member States to invest in a “sustainable financing mechanism” with a view to strengthening public health systems in the long-run.

“It’s irrational to have an organization like the WHO funded at 82% with voluntary contributions. You cannot have a fire brigade that has to raise money when it catches fire, that is irrational.”

Furthermore, it is important that funding be directed more strategically toward long-term strengthening of core capacities of public health systems like prevention, surveillance and response to disease outbreaks, the two legal experts said.

“Investments cannot immediately respond to a short term profit or political gain…Long term investment in public health care [is needed]…I hope that the WHO would play a role in that”, said Burci.

“It is not a do it once and it’s done”, said Solomon. “Maintaining core capacities is much more like brushing your teeth. It needs to be done every single day in a determined way”.

Image Credits: WHO/L. Cipriani, WHO .

Polymerase Chain Reaction (PCR) test for the virus that causes COVID-19 respiratory disease, SARS-CoV-2.

With COVID-19 pandemic curves beginning to flatten out in many parts of the Europe, Health Policy Watch presents a snapshot of infection and death trends in WHO’s European region through graphs that tell the story, using up-to-date data from the COVID-19 tracker of the Geneva-based Foundation for Innovative New Diagnostics (FIND).

Notably, some striking, but little discussed, differences in deaths, disease incidence and rates of testing exist among Switzerland, Czechia, Denmark, Norway and Sweden – countries with similar population sizes and age demographics, quality health systems and high development indices.While a great deal of attention has been focused on the situations faced by Europe’s big powers, including the United Kingdom, Italy, France and Spain, on the one hand, and Germany on the other, trends in these smaller, central and northern European countries are also revealing -with death rates in Czechia particularly low, followed by Norway and Denmark.

While it will take more time and expert review to etch out the basket of policies that worked best together, the snapshot of trends is suggestive of questions that will have to be asked and the mix of policies that may or may not be most effective.

The lesson in the data seems to indicate that there is no one policy that works on its own, but rather an integrated package  – as the World Health Organization has long stated. And countries that test more and test earlier have better curbed the spread of the virus, as well as deaths resulting from COVID-19 infection.

See below the three key indicators in data: death rate, testing and number of reported COVID-19 cases. Note these are presented in per million,  to make comparisons more equal.

Death Rates – The Ultimate Indicator
(HPW/Svĕt Lustig): Sweden’s death rate due to COVID-19 is much higher than Norway and Denmark. Based on national data collected by FIND (finddx.org), 20 April, 2020.

Death rates, if reported accurately, are the ultimate indicator of a country’s outbreak response policies – at least among countries with similar age demographics and underlying health conditions. Death rates can be seen to reflect the success of the whole range of measures taken, including testing and contact tracing and the quality of hospital care as well as physical distancing through quarantines and lockdown measures.

Whatever the combination of policies that worked and did not, it remains striking that deaths, per capita, have been much higher in Switzerland and Sweden as compared to Denmark, Norway and Czechia, which also tested more aggressively in the early days.

Denmark, Norway, and Czechia also cancelled mass events, closed leisure facilities and restaurants for dining, adopting strict social distancing measures comparatively early on in the initial epidemic surge, while Switzerland took those same measures more gradually and comparatively later in its outbreak, which began to spill over from Italy already in late February.

Czechia closed its borders early on, and ordered universal masking of its citizens. So did Czechia’s extraordinary measures keep its case load and death rates particularly low? And on the other hand, could it be that Norway’s more aggressive testing policies, also helped contribute to significantly lower mortality trends, much in the spirit of WHO’s admonition to “test, test, test”?

Sweden, which experienced relatively higher mortality, left most restaurants and shopping malls open throughout. Sweden’s ‘voluntary’ physical distancing measures were also much milder than those adopted in Norway and Denmark.

Israel, also a member of WHO’s European Region, is another country with very low death rates comparable to Czechia’s. Like Czechia, Israel adopted strict social distancing, quarantine and travel restrictions early on, although experts have also attributed the low death rate to the country’s comparatively younger population – an average age of about 30 as compared to 40-something averages of the the central and northern European countries featured here.

Countries That “Test, Test, Test” Can Reduce Death Rates – But Follow-Up Also Essential

WHO has stressed that testing lies at the heart of containing infectious disease outbreaks and helps save lives by allowing authorities to trace and isolate infected people accordingly.

“All countries should be able to test all suspected cases, they cannot fight this pandemic blindfolded, they should know where the cases are, and that is how they can take decisions,” WHO Director-General Dr Tedros Adhanom Ghebreyesus has stated repeatedly at WHO’s COVID-19 press briefings.

In Scandinavia, Sweden has lagged far behind Norway and Denmark in implementing widespread COVID-19 testing, a key World Health Organization-COVID-19 control strategy. Sweden has paid the price of low testing with significantly higher death rates.

Norway, on the other hand, has been the European country that consistently tested the most, from the early days of the epidemic until now. Norway’s testing rates were three times more than those in Sweden, while Norway’s deaths were only about one-fifth of its next-door neighbor. Denmark also tested twice as much as Sweden, while its death rate was less than half.
Switzerland has also tested more aggressively than any other country, just behind Norway. Despite having one of the highest ratios of cases, per capita, its death rate has been almost the same as Sweden. Once again, differences in testing may help explain these trends, as testing can help in case identification and reporting that reduces mortality. There are signs that Sweden has come to this conclusion too. The country plans to expand testing now by a factor of six to 100 000 tests a week, targeting ‘key roles’, such as policemen, firefighters, and healthcare workers, said Swedish Health Minister Lena Hallengren last Friday at a press conference. 
(HPW/Svĕt Lustig): Sweden focused less on testing than its neighbors. Based on national data collected by FIND (finddx.org), 22 April, 2020.
But testing is merely the first step in an outbreak response, public health experts have stressed.

“Testing is a hugely important central piece of surveillance, but we need to train hundreds or thousands of contact tracers [to follow up on positive cases and contacts]. We need to be able to find cases, we need to be able to isolate cases who were confirmed,” said WHO Executive Director of Health Emergencies Mike Ryan. 

In Norway and Denmark, the widespread availability of testing as part of a comprehensive ‘package’ of policies, has allowed authorities to quickly identify and quarantine people to effectively reduce deaths – although again, these measures were also accompanied by quarantines and physical distancing.

Drop-in testing clinic outside a health clinic in the ultra-orthodox city of Bnei Brak – one of Israel’s virus hotspots

Norway and Denmark are not the only European countries that have seen the fruits of testing.  Despite being hit by heavy waves of cases from Italy and France, Switzerland has had comparatively high testing, which could have helped fend off an even wider outbreak as it faced the onslaught of cases imported from Italy, which was Europe’s virus epicenter.

“Testing is important in fighting COVID-19. Switzerland is testing more and more”, said Swiss Federal Councillor Alain Berset, in a tweet in late March.

Israel has also ramped up testing capacity recently to one of the highest in Europe – aggressive testing along with precision case tracking and isolation has been viewed by experts there as key to “lockdown exit” strategies – and its army has even taken on a central role, mapping disease incidence house by house in the most heavily infected, ultra-orthodox towns and neighborhoods.

Case Rates Per Capita Across Europe
(HPW/Svĕt Lustig): Sweden, Denmark and Norway have similar case numbers. Based on national data collected by FIND (finddx.org), 20 April, 2020.

Experts have warned that reported cases may not reflect the true picture of disease spread – due to the very different rates in testing that countries have practiced.  Strikingly, Switzerland has one of the highest numbers of reported cases, per capita, in Europe, outpacing even those of neighboring Italy and double those of Sweden. However as one of the countries testing most aggressively, it may be that Switzerland has also simply been more diligent about case tracking and reporting, while cases that passed under the wire elsewhere. In light of its high case rate, the comparatively lower mortality may be a qualified success.

Clearly, however, Switzerland’s proximity to Italy and France, as well as the fact that lockdown measures may have been implemented later in the epidemic surge than in the other countries noted here, may have also played a role in high case incidence.

Czechia Gets The Highest Marks Across The Board – So Far
Homemade mask production for members of the public have become a big part of Czechia’s containment strategy.

At the very other end of the scale, Czechia has reported the lowest number of cases, per capita. And while Czechia’s testing rates are not as high as other countries like Israel or Norway, Czechia also has one of the lowest mortality rates in Europe.

Strikingly, it is also one of the few countries in Europe that has made mask use mandatory in public spaces from the early days. Is it possible that along with the travel restrictions and lockdown measures, widespread and mandatory mask use helped Czechia slash the number of infected people to a minimum, as well as the death rate resulting from the disease?

Given that the Czech public was widely engaged in home-fashioned mask making, it is also likely that priority populations like healthcare workers did not lack access to masks. Last week, Czechia began lifting its lockdown.

Image Credits: Mehr News Agency, Israel Ministry of Health, Pavlina Fojtikova.

Microbiologist Kerry Pollard performs a manual extraction of the coronavirus inside the extraction lab at the Pennsylvania Department of Health Bureau of Laboratories on Friday, March 6, 2020.

World Health Organization experts are urging countries to use caution when determining whether to use large scale serological testing as part of their exit strategies from lockdowns.

Serological testing identifies whether a person’s blood has antibodies for SARS-CoV-2, the virus that causes COVID-19,  indicating that they were exposed to the virus at some point and recovered – if they are not carrying the virus itself at that point. 

However, “nobody is sure whether someone with antibodies is fully protected against having the disease or being exposed [again],” Maria Van Kerkhove, WHO’s Technical Lead on the COVID-19 crisis told reporters in a Friday WHO briefing.

In addition, only a comparatively low proportion of the population may have so far acquired the antibodies. And that means the potential of  “herd immunity” to purportedly provide a crude shield of protection for others who have not been exposed, may be weak or non-existent, the WHO experts warned.

“There’s been an expectation, maybe that herd immunity may have been achieved and that the majority of people in society may already have developed antibodies,” said WHO’s Emergencies Head, Mike Ryan.  “[But] a lot of the preliminary information that’s coming to us right now, will suggest a quite a low proportion of the population have actually sero-converted [with antibodies that can fight the virus]. 

“I think the general evidence is pointing towards a much lower prevalence so may not solve the problem that governments are trying to solve. And then thirdly, there are serious ethical issues around the use of such an approach, and we need to address it very carefully,” Ryan added. 

The ethical issues arise because herd immunity is a crude protective tool, which is generally only effective if a large majority of a country’s population has lived through the disease, experts say. And in the case of COVID-19, that would mean accepting the very high death rates that are occurring among older people and those with chronic conditions who fall ill.  

Added Van Kerkhove, “We also need to look at the length of protection that antibodies might give. Nobody is sure whether someone with antibodies is fully protected against having the disease or being exposed.” 

Some of the tests also are not sensitive enough and may yield false positives she said, giving people the impression that “they’re sero-positive and protected,” where in fact they may be susceptible to disease, added Van Kerkhove. 

But the rapid development of serological tests just a few months into the pandemic is “a good thing,”  added Van Kerkhove. However with the number of new tests flooding the market, “we need to ensure that they are validated,” she said.

New guidance from WHO on the use of serological tests will be released this weekend, according to Van Kerkhove, speaking at WHO’s Friday briefing on the COVID-19 emergency.

“I think what we do have is advice for countries to be very prudent at this point,” said Ryan. “And number one, we need to be sure that tests would be used to establish the status of an individual, and there’s lots of uncertainty around what sort of what such a test would be and how effective and how well performing that test would need to be.” 

Many countries and companies are already looking towards the emergency use of serological tests, including Switzerland, the United Kingdom, Chile, and the US. Roche, the Swiss pharma giant, was the latest biomedical powerhouse to announce they were developing a COVID-19 antibody test, with the aim to roll it out in May.

(left-right) Mike Ryan, Dr Tedros, and Maria Van Kerkhove sitting 2 metres apart at the regular WHO COVID-19 Press Briefing
UN AIDS Calls For Dramatic Scale-Up of Healthcare Spending As COVID-19 Response

Meanwhile, the Executive Director of UNAIDS called for governments to “invest in universal social protection,” and dramatically scale up healthcare spending in response to the COVID-19 emergency. It was the first major statement by the organization on the health emergency. 

“COVID-19 is killing people. However, the scale and the consequences of the pandemic are man-made,” said Winnie Byanyima, UNAIDS Executive Director, speaking at an event Thursday cosponsored by the Global Development Policy Center and the UN Conference on Trade and Development.

Winnie Byanyima

 

Byanyima also drew attention to the economic fallout of the COVID-19 crisis, warning that the poorest populations, facing a triple threat of COVID-19, loss of livelihoods, and climate crises, are those likely to be hardest hit by the crisis.

“COVID-19 is expected to wipe out the equivalent of 195 million full-time jobs,” said Byanyima. 

In a related development,  Gavi- The Vaccine Alliance, was awarded a US$ 30 million grant by Netflix magnate Reed Hastings to support the organization’s ongoing vaccine work, in the shadow of  COVID-19.

“Global immunisation is vital to ending this terrible pandemic and Gavi’s hard-fought gains in this area will help prevent more lost lives and livelihoods,” said Hastings in a press release, about the donation by the Reed Hastings and Patty Quillin Foundation, named after him and his wife. “We hope that our contribution will help those most in need, but also to inspire other businesses, entrepreneurs and organizations to join in this urgent effort.”

The support comes at a particularly significant moment, since over the past week, humanitarian aid groups as well as African health leaders have expressed concerns that other vital disease control activities, including  immunizations could be harmed, by the recent suspension of funds by US President Donald Trump to the World Health Organization.  The donation is the first private sector contribution towards Gavi’s Sixth Replenishment drive, which aims to raise at least US$ 7.4 billion in 2020 to immunise 300 million children and save 8 million lives over the coming five years.

European Union Submits WHA Draft Resolution Supporting COVID-19 Intellectual Property Pool

While so far no vaccine exists for COVID-19, the debate over how to ensure equitable access to any new therapy continued to accelerate, following the European Union’s publication Wednesday of a Draft World Health Assembly Resolution calling for a global intellectual property pool of COVID-19 drugs, vaccines and diagnostics. 

The European Union proposal calls on WHA member states to explicitly support the creation of a voluntary pool of intellectual property rights for COVID-19 technologies.  If adopted, the proposal would pave the way for WHO to actively coordinate such an activity along with the UN-supported Medicines Patent Pool. The 74th WHA is scheduled to meet May 17-23, although there has been no announcement so far of whether the meeting might be held virtually or be delayed, due to the continuing lockdown measures in Switzerland, which has had some 25,000 reported cases so far. 

In an op-ed published this week in The Lancet, two lead negotiators of last year’s landmark World Health Assembly resolution to increase drug and R&D cost transparency, Luca Li Bassi and Lenias Hwenda, came out in support of the EU call. The call was first launched by the Costa Rica government in an open letter to WHO Director General Dr Tedros Adhanom Ghebreyesus in late March. 

“We urge Member States who adopted the World Health Assembly 72 Resolution on “Improving the transparency of markets for medicines, vaccines, and other health products” to formally support the request from Costa Rica’s Government,” wrote Li Bassi, former director of the Italian Pharma Agency and lead negotiator of the 73rd World Health Assembly “transparency resolution”, and Hwenda, chief executive officer of Medicines for Africa, in their comment. 

The EU draft resolution called for international actors, NGOs, and private industry, to “work collaboratively at international level to develop, test and produce safe, effective, quality diagnostics,  medicines and vaccines for the COVID-19 response, and to facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions.” 

The EU move came just a week after World Health Organization Director General Dr Tedros Adhanom Ghebreyesus himself welcomed the initiative to pool IP rights for COVID-19 diagnostics, vaccines, treatments, and data, along with the Medicines Patent Pool. Rights holders would submit patents and other rights voluntarily to the new COVID-19 pool, which can then license those rights to other manufacturers to increase access to research, data, and blueprints needed to ramp up production of COVID-19 technologies.

Still, more steps must be taken to “make sure that the resolution adequately reflects the Costa Rica proposal, which has already been endorsed by a number of Member States, including the Netherlands,”  Jaume Vidal, senior policy advisor at Health Action International told Health Policy Watch. “That means a COVID-19 technology pool hosted and managed by WHO based on non-exclusive – and not geographically limited – licensing.”

Still, the move is “a welcome first step by the European Union to achieve a collective solution, within a multilateral framework, to a global pandemic,”  said Vidal.

World’s Largest COVID-19 Drug Trial Set To Begin in the UK 

Meanwhile, the UK was set to launch the largest ever randomized controlled trial that aims to systematically compare several of the leading COVID-19 therapies to see how well they perform. Those therapies will include a hydroxychloroquine + azithromycin combination that showed initial results in a French trial; a combination of two antiretroviral drugs used in HIV treatment, lopinavir-ritonavir; and low-dose dexamethasone, a type of steroid used in a range of conditions, typically to reduce inflammation. 

The so-called RECOVERY trial, which has been set up in the United Kingdom at unprecedented speed, has recruited over 5,000 patients from 165 National Health Service hospitals in a month, and is hoping to have initial results as early as June. However, Peter Horby, professor of emerging infectious diseases and global health at Oxford University, who is leading the trial, warned that there is “no magic bullet” for COVID-19. 

As for hydroxycholoroquine, which has even been touted by political leaders such as Trump, Hornby stressed, “There is in-vitro evidence that it is inhibitory against the virus [in the lab]. But I haven’t seen any sound clinical data.”  Other drugs will be added to the trial later. 

Enrollment in the trial has been offered to adult in-patients who have tested positive for COVID-19 in NHS hospitals, and who have not been excluded for medical reasons. Patients joining the trial will be allocated at random by computer to receive either lopinavir-ritonavir or dexamethasone, or no additional medication. This will enable researchers to see whether any of the possible new treatments are more or less effective than those currently used for patients with COVID-19.

Global COVID-19 Death Toll Increases as China Revises Figures For Wuhan – Has Implications for Mortality Rate Estimates Globally 

In China, officials announced a revised death toll from COVID-19 in the original virus epicenter of Wuhan, adding 1290 more deaths to the tally – for a total of 3,689 in Wuhan and 4,636 in China as a whole.

The revisions have implications for COVID-19 death toll estimates more broadly, insofar as worldwide baseline mortality estimates, which have hovered around 3.4%, according to WHO, were largely based on Chinese data, which had the largest proportion of cases so far, where the disease also ran its term. More recently, however, death rates in some countries, such as Italy, soared as high as about 10%, while they have been below .02% in other countries that took measures early, such as Norway, New Zealand, Iceland, and Israel. Experts have underlined that death rates are influenced not only by population age, but also quality of hospital care that seriously ill people receive, and reporting patterns. 

The changing figures are likely to further fuel the fires of criticism over China’s reporting on the pandemic. While US President Donald Trump has been the most outspoken, lashing into the WHO in particular over being “China-centric” other western leaders have also now chimed in with criticism leveled directly against China for downplaying or covering up the virus emergence in the early stages, losing valuable time and laying the groundwork for its widespread circulation in China and ultimately globally. On Thursday, Dominic Raab, the foreign secretary of the United Kingdom said that there would be “hard questions” for China on handling the crisis, as did French president Emmanuel Macron, who criticised the lack of transparency in data. 

Their comments came after a damning Associated Press report that stated China sat on important information about the virus spread for six days between January 14-20. According to notices on Chinese University websites, schools have received instructions that “papers related to virus tracing should be managed strictly,” and must be reviewed by the college’s own academic committee, and submitted to the National Academy of Sciences before submitting for publication in formal academic journals. Scientists largely believe that the virus first originated in bats, then passed to humans through an intermediate host, potentially through a pangolin, an animal that may have been illegally traded at a Wuhan wet market. As China clamps down on research over the virus origins, debate is growing around the theory that it may have first infected humans in a Wuhan virology lab situated close to the wet market.

To a certain extent, these previously unaccounted-for deaths can also be attributed to a focus on treating cases rather than reporting deaths during the early stages of the pandemic, as well as many people dying at home and delays in data collection from various sources. In addition, authorities have also bounced back and forth in terms of how they counted  confirmed cases.

Total cases of COVID-19 as of 17 April 2020, with active case distribution globally. Numbers change rapidly.
Nordic Countries and New Zealand Join Chorus Decrying US Move to Suspend Aid To WHO 

Despite the new criticisms being leveled against China, international opinion continued to run strong against the recent US decision to suspend aid to the WHO ostensibly for being too pro-Beijing. 

The latest statements came from a group of five Nordic countries and New Zealand’s former prime minister, Helen Clark.  

“We as Nordic ministers for development cooperation are convinced that the work of WHO is essential during these critical times. Evaluation of their work will come later. Now is time for more international cooperation and solidarity – not less,” said the statement on behalf of Finland, Denmark, Sweden, Norway and Iceland, in a tweet posted by Norweigian Minister of International Development, Dag Inge Ulstein.

“The decision of the US government to defund WHO is disastrous,” Clark tweeted. “WHO is working to turn the tide on COVID-19; it is not responsible for a President ignoring advice which could have seen a fast USA response & saved thousands of lives. This is no time for a blame game.”

The decision has already been roundly criticized by other global leaders and heads of state including: UN Secretary General Antonio Guterres, European Commission Vice-President Josep Fontelles, and billionaire health philanthropist Bill Gates. 

US President Donald Trump announced on Tuesday the country was putting a halt on funding while the administration conducted an investigation into WHO’s handling of the coronavirus crisis, criticising the organization for alleged missteps in the early days of the pandemic. 

The WHO Staff Association released a letter to Dr Tedros on Thursday supporting the WHO’s pandemic response in light of the suspension of US funding to the organization.

“We regret that our Organization has been the target of unhelpful verbal attacks and threats, while we are in the midst of this health crisis,” said WHO headquarters personnel in a heartfelt letter. “WHO HQ’s personnel wish to join with individuals and other organizations around the world, in expressing our full support to our colleagues working tirelessly on the frontlines of this pandemic, and to you, Dr Tedros. 

“This pandemic has shown us that rapid transformational change and remarkable international collaboration are possible… We stand by your statements that this is the moment for all of us to rise to the challenge of collaborative leadership.”

Trump Unveils Plan For Phased Reopening Amidst Concerns About Insufficient Federal Support For Critical Testing; Bolsonaro Replaces Health Minister

President Donald Trump issued broad federal guidelines outlining the reopening of the country on Thursday April 16. The 18-page document, titled “Opening Up America Again” lays out a three-phase approach to relaxing social distancing measures, depending on the trends in new cases and new deaths.

The Trump guidance comes even as states such as New York extend the shutdown of non-essential businesses to 15 May, and issue rules for wearing masks in public. Ultimately, the power to reopen rests in state governors’ hands. 

Health officials have stressed the need for increased testing before Americans can safely return to work — following reports that the federal government will curtail funding for coronavirus testing sites. State officials have expressed that states will not be able to ramp up testing without federal support. Democratic House and Senate members have also urged him to wait for testing to become more widespread before announcing measures for reopening the economy, as has the Infectious Diseases Society of America. The United States has the highest number of confirmed COVID-19 cases and deaths globally, with over 650,000 confirmed cases and 33,288 deaths. 

Brazilian president Jair Bolsonaro removed health minister Luiz Henrique Mandetta from his position on Thursday. The President has received widespread criticism for repeatedly dismissing the severity of the coronavirus pandemic, calling it “just a little cold” and making highly publicized visits to crowded public spaces without protective gear, 

Mandetta, who has been at odds with the president’s views, has advocated for large-scale social distancing measures and quarantines. On the day he stated that the worst of the pandemic was yet to hit Brazil, Bolsonaro told religious leaders, “this issue seems to be going away”, thus creating confusion for people over who to listen to. However in a recent survey, some 76% of respondents were in favour of the health minister’s response to the pandemic, and less than 30% trusted the president’s approach. 

Mandetta’s replacement Nelson Teich, an oncologist and healthcare executive, shares similar views in recently published articles, where he too endorses scientific social-distancing and isolation measures.Brazil currently records more than 30,000 confirmed cases with almost 2,000 deaths although Edmar Santos, Health Secretary for Rio de Janeiro, estimated that the real case count was much higher due to under-testing.

Gauri Saxena and Grace Ren contributed to this story

Image Credits: Twitter: @WHO.

Matshidiso Moeti, WHO Regional Director for Africa at regular press conference

The impacts on Africa of United States President Trump’s decision to withhold funding to the WHO will be ‘quite significant’ as the US is the “number one contributor” of the WHO African Region budget, said Matshidiso Moeti, WHO Regional Director for Africa, at a joint press conference hosted by the WHO and the World Economic Forum today.

Meanwhile, a number of prominent national African health leaders signed an open letter in The BMJ calling the Trump move “petulant” and “short-sighted”.  And in a move to counter some of the budget shortalls, the Bill and Melinda Gates Foundation announced an emergency allocation of US$ 150 million to the WHO to “help speed up development of vaccines, treatment and public health measures” to tackle the pandemic. That was in addition to a previous US$ 100 million emergency allocation.

Africa is the WHO region that stands to lose the most from Trump’s decision to suspend or possibly cut funds, should his move be endorsed by the US Congress, said Moeti, as Washington is the “one of the biggest supporters” to WHO programmes in the region.  The suspension could affect Africa’s longstanding attempts to eradicate polio, as well as other programmes that address HIV, malaria, and work on strengthening Africa’s health systems, she said. 

“We are hoping that this decision will be re-thought because the USA is an important strategic partner…and we value this relationship with the USA,” Moeti stressed.

So far, the African Region has only received a third of the promised $151 million contribution from the US for the current 2020-21 budget period, she added, and money needs to keep on coming for COVID-19 preparedness plans as well as other disease control activities to continue.

“We will need about $300 million for the next six months in order to support what [African] countries are doing,” said Moeti. 

Among the burning issues is a resurgence of deadly Ebola virus in the Democratic Republic of Congo.

Since Friday, four new cases of Ebola have been reported in the Democratic Republic of the Congo (DRC) after 54 days without a new case, said WHO Director General Dr. Tedros Adhanom Ghebreyesus today at a briefing of UN Missions in Geneva. These reports came just days after the Director General had announced last Monday that DRC “could declare” the Ebola outbreak to be over if no further cases were announced during the week. 

As for COVID-19, the pandemic can still be contained in most African countries, Moeti contended, if action now is sustained.

Africa has reported over 17,000 cases of COVID-19, and around 900 people have already lost their lives, said Moeti, citing the most recent Africa Centers for Disease Control data. South Africa, Nigeria and Cameroon now account for around half of confirmed cases, and mortality is ‘rather high’ in countries of West and Central Africa, said Michel Yao head of emergencies for the WHO Africa region.

However, as 28 out 47 countries in the WHO African region still only are experiencing sporadic cases, while only two countries, South Africa and Algeria, are experiencing widespread community transmission and 14 countries have reported local transmission, Yao added.

“We must seize this window of opportunity,” said Moeiti.

Elsie Kanza, World Economic Forum Director for Africa applauded the recent moves to repurpose factories in South Africa and Kenya to produce ventilators and protective equipment. This followed on a call earlier from a Geneva-based NGO for more investment to improve regional manufacturing capacity in the African continent. 

She noted that providing local work opportunities was also important in light of the fact that about 80% [of Africans] are employed in the informal sector, and one recent McKinsey study estimates that “about one third of Africans are likely to lose their jobs”, as a result of the pandemic.   

In the African context, virus containment is also challenging since physical distancing is “impossible” in various situations, said Dr Tedros in his missions briefing, especially in densely populated areas.

“The virus is moving into countries and communities where many people live in overcrowded conditions, and physical distancing is nearly impossible,” he said. “Vaccination campaigns for polio have already been put on hold, and other vaccination programs are at risk because of border closures and disruptions to travel,” the Director General added. 

Dr Tedros added that WHO was calling on governments to rigorously enforce bans on so-called “wet markets” where illegal wildlife are commonly contained and sold in Asia for their meat, and as ingredients in traditional medicine. Illegal capture and sale of reptiles, endangered pangolins, or other wild animals in a Wuhan China wet market is believed to have been the source of the COVID-19 leap from animals to humans. 

“WHO maintains that governments should rigorously enforce bans on the sale of wildlife. And they must enforce food safety and hygiene regulations to ensure that food that is sold in markets is safe”, Dr. Tedros added.

For 2020-21 – The United States Had Committed To 15% of WHO Funding 
Top contributors to WHO’s Budget (2018)

The U.S. provided $893 million of the WHO’s funding over the last two-year budget period of 2018-19. That represented about one-fifth of WHO’s total $US 4.4 billion budget for those years. Of those funds, nearly three-fourth were earmarked for “specified voluntary contributions” while the rest was provided as “assessed” funding, or part of Washington’s general commitment to the WHO. 

In 2018-2019, Africa received some US$ 1.64 billion in WHO funding, with most funds as “earmarked” contributions by member states. The US was the biggest contributor, with 31% of the total contributions to Africa – almost twice as much as the United Kingdom and 2.5 times more than Germany.

In its most recent budget proposal for WHO, dating to February 2020, the Trump administration had already called for slashing the U.S. assessed funding contribution to the Organization by US$ 57.9 million in the current budget year – a move that had prompted an outcry from Washington observers who noted that the move was ill-timed in light of the COVID-19 crisis.

Trump’s attacks on WHO, have revolved around the Organization’s allegedly slow reaction to the coronavirus threat in early January which he claims pandered to China and cost lives.

However, US intelligence agencies were aware of the coronavirus outbreak by mid-November, drew up a classified document, and alerted NATO as well as Israel’s security forces, which did nothing about it, Israel National Television N12 station reported on Thursday.

“US intelligence informed the Trump administration, “which did not deem it of interest,” the reported stated, adding that even so, the Americans decided to update two allies with the classified document: NATO and Israel.

Prominent Scientists Worldwide Protest US Decision to Suspend Support 

In an letter addressed directly to Dr Tedros, published in the prominent medical journal, the BMJ, a series of leading African, British, Canadian and American public health experts protested the US move saying that they had noted with concern “recent personal and institutional attacks against you.”

“We want to let you know that the world and humanity needs the institution of the World Health Organization (WHO) now more than ever. In the wake of the COVID -19 pandemic the technical guidance and leadership of the WHO that you and the leadership team in Geneva, Regional and Country Offices round the world is valued and appreciated”, stated the letter, which was signed by members of a Commission that authored a report: “The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises” in 2016.

“Having reviewed a wide range of options for a coordinated global response to infectious diseases, we concluded that the WHO is best placed to play the leadership and coordinating role and that if there was no WHO, we would have to invent one,” the signatories of the letter stated.  “At this critical time in human history, it has fallen upon you and your WHO team to carry the singular responsibility of leading and coordinating the global charge to stop COVID -19 from killing more people and wreaking more collateral economic and social damage to the world.”

The letter was signed by renowned Ugandan heart surgeon Francis Omaswa, former university chancelor who now heads the African Center for Global Health and Social Transformation in Kampala, along with academics from Tanzania, South Africa, Ethiopia, as well as the UK, Canada and the United States.

Meanwhile, in a press release issued on Thursday, the American Society of Tropical Medicine and Hygiene, described the Trump move as “reckless and counterproductive,” and called for support to be immediately resumed.

“In the midst of a global pandemic, withholding U.S. funding from the World Health Organization is reckless, harmful and counterproductive. A step like this only encumbers the global response against COVID-19 instead of bolstering it. It makes no sense from an economic, social or health perspective,” said the statement by the ASTMH, which hosts one of the most prominent global conferences on health and science themes every year.

“The WHO serves as the frontline support system for all countries—including the United States. Working together is the smartest, most efficient and cost-effective way to confront this unprecedented, spreading global health crisis. No other organization can play the role of WHO or its central diplomatic role or perform the service they do across borders and cultures.”

The organization stressed that the US move could have immediate repercussions in low-income regions such as Africa, saying: “Some of the wide-reaching consequences that could occur from cuts in U.S. funding are:

  • Cancelling the shipment of masks, gowns and gloves to healthcare workers caring for COVID-19 patients around the world.
  • Decreasing or terminating COVID-19 testing in sub-Saharan Africa.
  • Ending testing for Ebola virus disease in the ongoing outbreak in the Democratic Republic of the Congo, and an interruption to tracing the contacts of infected people in efforts to contain the disease.”

Easing the Lockdown in Europe

As a handful of European countries slowly start to lift their lockdowns, the WHO recommended to governments that they aim to satisfy 6 criteria prior to opening up again. The criteria are contained in the recent WHO strategy update issued earlier this week.  These criteria include ensuring a tight clamp on continued COVID-19 transmission; strong health infrastructure to test, trace and isolate cases; preventative measures in public spaces and healthcare settings; a system for managing risks from virus importation by arriving travelers; and full community engagement in the battle against the virus.   

Switzerland was set to gradually ease countrywide lockdown restrictions over coming weeks, following recent moves by Denmark, Austria, The Czech Republic and Germany. The Federal Council announced on Thursday that hospitals will resume all routine medical activities on 27th April. Businesses offering personal services such as hairdressing, salons, massage and cosmetic studios will be allowed to reopen starting April 27th. Pending further development of the pandemic, primary and secondary schools will reopen on 11 May while higher education institutions, as well as museums and libraries, are set to reopen 8th June. 

Total cases of COVID-19 as of 6:56 PM CET 16 April 2020, with active case distribution globally. Numbers change rapidly.

Tsering Lhamo contributed to this story. 

Image Credits: WHO .

Dr Tedros speaking at WHO’s regular COVID-19 press briefing.

The European Union, China, and Norway Wednesday joined UN Secretary General Antonio Guterres in decrying United States President Donald Trump’s decision to suspend US funding to the World Health Organization – at a critical moment in the international agency’s coordination of the global COVID-19 response.

Trump announced Tuesday night that the US administration would suspend WHO’s funding for a “term of 60-90 days” pending an investigation into the agency’s handling of the coronavirus pandemic. However, it’s unclear whether his decision can really be implemented without being approved by the US Congress, which approves allocations to the agency. 

Despite repeated attacks by the US president over the past week, WHO Director-General, Dr Tedros Adhanom Ghebreysus struck a conciliatory note in a press briefing Wednesday, saying: “The United States has been a longstanding and generous friend to WHO, and we hope it will continue to be so. We regret the decision of the President of the US to order a halt in funding to WHO.”   

UN Secretary General Antonio Guterres decried the US move, in protests that were quickly echoed by the European Union, China, and Norway as well as global health philanthropist Bill Gates and a range of other global health organizations.  Richard Horton, editor of the prestigious biomedical journal The Lancet, which has steered an independent line on the handling of the crisis, called it a “crime against humanity.”

“It is my belief that the World Health Organization must be supported, as it is absolutely critical to the world’s efforts to win the war against COVID-19,” said Guterres in a press release. 

“There is no reason justifying this move at a moment when [WHO’s] efforts are needed more than ever to help contain and mitigate the coronavirus pandemic,” Vice-President of the European Commission Josep Borrell Fontelles tweeted Wednesday.

Fontelles added that he “deeply regrets [the] US decision to suspend funding to WHO…. only by joining forces can we overcome this crisis that knows no borders.”

Individual countries also decried the US moves, with current and former Norwegian leaders among some of the most critical voices. 

“The last thing we need now is to attack the WHO,” said Gro Harlem Brundtland, former Norwegian prime minister as well as having been herself at the helm of the WHO from 1998-2003 when the SARS crisis erupted in Asia, speaking to the Norweigian News Agency.

Norwegian Health Minister Bent Høie added, “It’s more important and critical than ever to support the important international work that’s being done to stop the pandemic…Norway believes we must strengthen WHO in its work, not weaken the organization.”

Chinese Foreign Ministry officials, meanwhile, “expressed serious concerns” over the suspension of US funding. Spokesman Zhao Lijian said in a Wednesday briefing, “The decision of the US will weaken the WHO’s ability to handle the pandemic, especially the nations whose capabilities are not well developed.”

Global Health Community Condemns WHO Defunding 

Leaders in the global health community also sharply criticized the US administrations’ moves. 

“Every scientist, every health worker, every citizen must resist and rebel against this appalling betrayal of global solidarity,” he tweeted in a fiery comment on Wednesday.

In a similar vein, the heads of global health’s biggest philanthropies condemned the suspension of funding, even urging the US to step up financing for the Organization during the global crisis.

“Halting funding for the World Health Organization during a world health crisis is as dangerous as it sounds…The world needs WHO now more than ever”, Bill Gates of the Bill and Melinda Gates Foundation (BMGF), the global health industry’s largest private donor, tweeted Wednesday. “Their work is slowing the spread of COVID-19 and if that work is stopped no other organization can replace them.”

“The World Health Organization (WHO) plays a critical role and needs more resources, not less, if we’re to have the best chance of bringing this pandemic to an end,” added Jeremy Farrar, director of the Wellcome Trust, a major funder of global health research and development, in a statement released Wednesday. “We are facing the greatest challenge of our lifetime…No other organisation can do what [WHO] does.

““Viruses know no borders, as COVID-19 has proven. The only way out of this pandemic is by working together and ensuring all countries, especially lower and middle income countries, have the tools and resources to tackle this.”

“There is only one adversary here: the virus. It is in all our best interests to work with and strengthen the WHO”, said Jose Luis Castro, President and CEO of Vital Strategies, a global public health organization and trusted partner of governments, in a tweet.

US Politicians & Organizations Push Back Against WHO Funding Suspension

The US President announced on Tuesday at a White House briefing that funding to WHO would be suspended pending an investigation, due to what he claimed had been a pattern of “severely mismanaging and role in covering up the spread of the coronavirus.” 

In his 10 minutes of prepared remarks Tuesday night, Trump alleged that “WHO’s reliance on China’s disclosures likely caused a twenty-fold increase in [COVID-19] cases worldwide”– he did not cite a source for the claims.

US President Donald Trump At Coronavirus Press Briefing

Almost immediately after the President’s announcement, US politicians from the Democratic party heaped scorn on the decision, claiming that Trump was scapegoating WHO for missteps by his own administration. 

“Withholding funds for WHO in the midst of the worst pandemic in a century makes as much sense as cutting off ammunition to an ally as the enemy closes in,” US Senator Patrick Leahy said Tuesday “This White House knows that it grossly mishandled this crisis from the beginning.”

Along with claiming that WHO had played into China’s hands in its handling of the crisis, Trump also directed his ire towards WHO’s early opposition to travel restrictions and bans, claiming it was one of the Organization’s “most dangerous and costly decisions.” 

Throughout January and much of February, WHO had recommended against such bans due to advice from independent public health experts, but the Organization never directly referenced the US in its critiques.  

In a follow-up statement released on Wednesday, The White House further alleged that missteps taken by the WHO included hiding early reports of human-to-human transmission from the public.

The White House claims that WHO had ignored early warnings from Taiwan, whose government is not recognized by WHO’s governing body of member states, about the emergence of the virus and possible human-to-human transmission.

“Taiwan contacted the WHO on December 31 after seeing reports of human-to-human transmission of the coronavirus, but the WHO kept it from the public,” alleged the White House statement on the suspension of WHO funding.

On 15 January, WHO Emergencies Technical Lead Maria Van Kerkhove first told journalists that it was possible that the virus was being transmitted, human-to-human, saying, “From the information that we have, it is possible that there is limited human-to-human transmission, especially among families who have close contact with one another.”  

The White House statement also took WHO to task for failing to declare the outbreak a “public health emergency of international concern” (PHEIC) on 22 January.

The Organization made the declaration a week later on 30 January. That was a month and a half before the US government declared a national state of emergency, and during a period when Trump even praised China at times for its management of the crisis, including in late January, when Trump tweeted “the United States greatly appreciates [China’s] efforts and transparency. It will all work out well. In particular, on behalf of the American People, I want to thank President Xi!”. 

China & Taiwan Reports at Center Of US Critique – WHO Tries to Set Record Straight 

In Wednesday’s WHO briefing, the head of WHO’s Emergency Team as well as WHO’s Legal Counsel, sought to set the record straight around some of the criticism that Trump and his Administration have recently levied.

WHO Executive Director of Health Emergencies Mike Ryan acknowledged that the agency had received reports from “multiple sources…on the 31st of December regarding a cluster of cases of atypical pneumonia in China.” All the reports “emanated from a press release or a publication on the website of the Wuhan Health Authority,” according to Ryan.

Kerkhove added that Taiwanese experts had also been invited to participate in key WHO working groups on infection prevention control and case-management of COVID-19 since the beginning of the pandemic. 

On the issue of Taiwan’s membership in the WHO however, the Organization’s hands were tied, WHO’s senior legal counsel stated. 

Steve Solomon, WHO’s principal legal officer said, “We are in the hands of countries on these issues. Operational staff doesn’t have the mandate or power to change that,” he said adding that the decision hearkens by to a vote by the UN in 1971: 

“In 1971, the countries of the United Nations decided to recognize the People’s Republic of China as the only legitimate representative of China…WHO is the specialized health agency of the United Nations and as such aligns with the United Nations and must do so coherently.”

Steve Solomon, Principal legal officer of the WHO, speaks on Taiwan’s legal status at a COVID-19 press briefing.

In a rebuttal of the WHO statements, Taiwan’s Mission to the United Nations in Geneva issued a statement on Wednesday evening, saying that UN and World Health Assembly decisions recognizing the goverment in Beijing as the representative of China, should not imply Taiwan’s complete  from consultations and decision-making mechanisms of the global health body. The official called upon WHO to invite Taiwan to this year’s upcoming World Health Assembly meeting of member states as an “observer.”

“UNGA [Resolution] 2758 and WHA [Resolution]  25.1 only addressed the question of China’s representation,” said Chenwei Ku, Assistant Director of the Mission. “It neither states that Taiwan is a part of China nor authorizes the PRC to represent Taiwan in the UN system. In fact, these resolutions have nothing to do with Taiwan’s meaningful participation in international organizations. In advancing its global health mandate, WHO should recognize the fact that Taiwan administers its own independent public health system, and only the Government of Taiwan, which is democratically elected by Taiwanese people, can represent 23 million Taiwanese people and can truly take full responsibility for the health and welfare of its population.

“During the current pandemic, Taiwan has further been taking actions to help the world combat the spread of COVID-19, by providing medical equipment and sharing relevant experiences. We call on the WHO to uphold its professionalism and neutrality as mandated by its Constitution, and to invite Taiwan to this year’s WHA as an observer and including Taiwan to fully participate in all WHO meetings, mechanisms and activities.”

World Leaders Call For WHO To Lead “Pan-African” COVID-19 Response Mechanism

Just as one country’s leadership was threatening to defund the WHO, some 18 African and European world leaders called on the WHO to lead a “pan-African” COVID-19 response, in a letter published on Wednesday by the European Council, the heads of state of members of the European Union. 

“We must support a pan-African scientific and political mechanism that will coordinate African expertise with the global response led by the World Health Organization, and ensure a fair allocation of tests, treatments and vaccines as they become available”, said the 18 country and regional leaders. The authors of the letter include Giuseppe Conte, Prime Minister of Italy;  Paul Kagame, President of Rwanda; Ursula von der Leyen, President of the European Commission; Angela Merkel, Chancellor of Germany; Charles Michel, President of the European Council; Cyril Ramaphosa, President of South Africa; and Felix Tshisekedi, President of Democratic Republic of Congo, among others.

With the WHO at the forefront, a “joint action plan” will be developed in collaboration with numerous organizations, including the World Bank, the ADB, Global Fund, Gavi and Unitaid. 

The letter also called for an “immediate moratorium on all bilateral and multilateral debt payments” as well as a $100 billion economic stimulus package to give the African continent fiscal space to respond to COVID-19.

Foreign aid should also promote regional manufacturing capacity to prevent over-reliance on donations, especially given unstable supply chains and sovereign need being prioritized over aid, said Yolse, a Geneva-based association focused on access to medical technologies in West Africa, in a statement to Health Policy Watch. 

“Today, very few African countries are in a position to produce protective equipment or even manufacture generics for diagnostic tools, future treatments and vaccines”.

“Aid to vulnerable countries should not be limited to treatments, vaccines and diagnostic tools. There is a need to support the creation of sustainable health infrastructure and promote production of essential medical products in sub-Saharan Africa.”

As therapeutics with potential to treat COVID-19 become more visible and widely-used, Yolse also urges African countries to take immediate legal measures to ensure equitable access to drugs, just in case pharmaceuticals patent them. 

“We call on OAPI Member States to take immediate national measures such as compulsory licensing or public non commercial use in order to avoid pharmaceutical patents being a barrier to access to future COVID-19 treatments and vaccines.”

Gilead’s HIV drug, Remdesivir, is patented by the African Intellectual Property Organization (AIPO), says Yolse, potentially hampering 13 member countries in development from gaining access to the drug.

Svet Lustig Vijay contributed to this story.

Image Credits: White House, Twitter: @WHO.

A common cause of death from COVID-19 is through a cytokine storm. Cytokines are chemical messengers released by the immune system.

New Delhi, India – COVID-19 has posed unique challenges for healthcare providers across the globe, as the world has been grappling with the pandemic with no approved treatments or vaccines for the disease. Researchers are searching everywhere for drugs that may help treat or prevent the spread of the deadly virus.

This has led to the assessment of a large number of already commercialized antiviral drugs, as well as new small molecule compounds currently in research and development. And as R&D advances, ensuring wide, equitable access to such drugs has also been thrust to the forefront of health policy debates, including frequent references to this pressing need by WHO’s Director-General Dr Tedros Adhanom Ghebreyesus, and his senior management.

Yet the robust biologic pipeline of candidates to treat COVID-19 or its symptoms – and the special role these drugs could play in the COVID-19 battle, has received far less attention. And should these prove effective, stiff barriers exist for the development of COVID-19 biosimilar compounds – beginning with WHO’s own guideline policies. In fact, access to potentially life-saving biosimilar products at an affordable price will remain a distant dream, unless WHO updates its Guidelines for the Evaluation of Similar Biotherapeutic Products (SBPs).

Biologics with Potential to Treat COVID-19  

So far, the drugs with the greatest potential include those aimed at host targets, such as interleukin-6 (IL-6) receptor inhibitors. Apart from this, many researchers and pharmaceutical companies are working to develop monoclonal antibody-based treatments.

In terms of IL-6, recent preliminary data on COVID-19 patients from China reported high plasma levels of cytokines, including IL-6, that are related to the severity and the prognosis of the disease with a clear implication for the occurrence of the deadly “cytokine storm” or Cytokine Release Syndrome (CRS).

Anti-IL-1 and anti-IL-6 drugs may therefore interfere with this cytokine storm, thus helping to reduce lung inflammation and improve lung function in severe cases of COVID-19 patients. Roche’s biotherapeutic Actemra, commonly known as tocilizumab, is an anti-IL-6 receptor antibody that has been used clinically to treat rheumatoid arthritis and other autoimmune diseases. Since its approval a decade ago, it has become the go-to drug against inflammatory conditions, including cytokine storms in cancer patients receiving cell therapies, and it has also been approved for the treatment of a variety of clinical conditions that include CRS.

A small cohort study in China has suggested that tocilizumab effectively improved clinical symptoms and repressed the deterioration of severe COVID-19 patients.

According to reports, a 3-month clinical trial with tocilizumab has been registered in China, that has recruited 188 coronavirus patients, and will take place from February 10 to May 10, 2020. Malaysia will begin a 6-month clinical trial involving about 300 COVID-19 patients starting in mid-April. Furthermore, Roche has also confirmed that it will expedite the trials of the drug to determine its effectiveness in COVID-19 patients.

Another biologics drug, Kevzara (Sarilumab) jointly developed by Regeneron and Sanofi, also inhibits the IL-6 pathway and clinical trials have been initiated for the treatment of patients with COVID-19. This U.S.-based trial will begin at medical centres in New York, one of the epicenters of the U.S. COVID-19 outbreak. The multi-centre, double-blind, Phase 2/3 trial has an adaptive design with two parts and is anticipated to enrol up to 400 patients.

Even though these biologic medicines hold promising avenues for the treatment of severe diseases, offering new hope for patients, the real question is how many people will really be able to access this class of drugs. With an estimated cost of infusions per patient per year between US$ 20,000 and US$ 30,000 for rheumatoid arthritis (RA) treatment, the U.S. was the drug’s biggest market, and Americans spent about US$ 620 million on tocilizumab prescriptions. This high price of tocilizumab already excludes it as a viable option for RA treatment in many low and middle-income countries. Introducing non-originator versions is the best way to reduce the price and enhance the supply. Unfortunately, this is not possible due to the high regulatory barriers to introduce the non-originator versions of biotherapeutics (biosimilars), which are in fact established by the WHO.

IL-6 inhibitors like Tocilizumab can dampen cytokine storm in patients with severe COVID-19.

WHO Guidelines On Biosimilar Approvals – Requiring New Phase 3 Comparative Trials

According to WHO’s own guidelines on biosimilar drug development, which date to 2009, regulatory approval for biosimilars requires developers to launch comparative Phase 3 Comparative Clinical Trials (CCTs) – a costly and time-consuming requirement that does not exist for generic versions of small molecules.

Nearly 50% of the development cost of a biosimilar is to purchase the originator version for the comparative clinical trials. This regulatory barrier virtually eliminates the competition even in the absence of patent protection. WHO is the main influential agency that has created these entry barriers; its own SBP guidelines make Phase 3 clinical trials a rule of thumb for biosimilar approval. Against these guidelines, the discretionary powers of national and regional regulatory authorities to approve biosimilars without Phase 3 trials remains very limited.

For instance, one of the conditions set down by the WHO guidelines for waiving Phase 3 trials of biosimilars is that the drug under review possess at least one identical pharmacodynamic (PD) marker, which is a marker linked to efficacy (e.g. an accepted surrogate marker for efficacy). In many cases, PD markers for efficacy do not exist, and hence biosimilar manufacturers are forced to carry out CCTs. Thus, WHO’s SBP Guidelines from 2009 have even delegitimised the diverse regulatory pathways that previously existed in many countries for approval of biosimilars.

Looking at the progress of scientific knowledge, technical advancements, accumulation of experience in the field and fast-expanding national regulatory needs and capacities, voices have been repeatedly raised, including those from the scientific field, to increase access and affordability of biosimilar products across the globe.

Life-saving biologics need to be affordable to the burgeoning population of people who can be successfully treated with these drugs. Last year a group of scientists wrote to WHO demanding a review of its SBP Guidelines, and elimination of Phase III Comparative Clinical Trials. The letter noted that advancement in analytical techniques enables the biosimilar developer to capture the molecule structure of the originator drug very accurately, and the structural similarity of the biosimilar is thus reflected in its therapeutic efficacy.

Requirements for CCTs should be replaced by requirements for detailed structural characterisation as part of the WHO guidelines, the scientists stated. The demonstration of similarity in quality is sufficient to assure the safety and efficacy of most products.

Emphasis on further testing should focus on quality-assurance, e.g. drug impurity profiles and potency. Further, the safety concerns should be addressed through in vitro studies. According to the scientists, carrying out Phase 3 trials in around 300 to 500 clinical subjects does not reveal any difference between similar products.

As Francois-Xavier Frapaise, one scientist in the field, stated in his paper: “Clinical trials are not powered to detect meaningful differences in the safety profiles of biosimilars, and when numerical imbalances in adverse events are observed during clinical development of a biosimilar, the interpretation of limited differences is very difficult; only large cohort studies may detect differences, if there are any, in safety parameters.”

Even so, WHO has consistently opposed changes to its SBP Guidelines.

Already in 2014, a World Health Assembly Resolution asked then-WHO Director-General Margaret Chan “to convene the WHO Expert Committee on Biological Standardization to update the 2009 Guidelines”.

But the Expert Committee in its subsequent meeting, refrained from any revisions, rejecting the decision of its highest decision-making body without citing any reason.

Once again, in October 2019, WHO’s Expert Committee on Biological Standardisation (ECBS) declined a request to revise the SBP Guidelines without citing any reason.

The Chair summary simply states: “Chair of the Committee communicated the conclusions of the Committee to the WHO Assistant Director-General MVP (Access to Medicines, Vaccines and Pharmaceuticals) who said that WHO will evaluate current scientific evidence to support the updating of the 2009 Guidelines”.

The summary failed to provide any scientific rationale for its decision. And since then, there has been absolute silence from WHO regarding the promised science review.

This stonewalling also generates doubts about whether such a review, whenever it is finally carried out, will be undertaken in a transparent manner and free of conflict of interest.

WHO’s reluctance to update its SBP Guidelines has effectually created a wall blocking access to generic versions of many important and expensive biologics medicines such as tocilizumab, and has inadvertently nudged COVID-19 patients to face the deadly cytokine storms without such drug treatments.

Will the organisation with a mandate to safeguard public health show greater accountability and transparency about biologics in this moment of a global pandemic?

_______________________________________

Chetali Rao is a lawyer specializing in patent, access to medicines and health issues.

 

 

K M Gopakumar works as Legal Advisor for the Third World Network (TWN).

 

 

Both authors are based in New Delhi.

Image Credits: Scientific Animations, University of Science and Technology of China, Chetali Rao, K.M Gopalkumar.