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.

Emma Walmsley discusses GSK’s new collaboration with Sanofi to develop a adjuvanted COVID-19 vaccine.

Two of the largest vaccines companies in the world, GlaxoSmithKline (GSK) and Sanofi, are teaming up to hasten vaccine development for COVID-19.

“By combining our science and our technologies, we believe we can help accelerate the global effort to develop a vaccine to protect as many people as possible from COVID-19”, said Emma Walmsley, chief executive officer of GSK, in a joint Sanofi-GSK press release on Tuesday.

“One of the important things in this collaboration is our combined scale. Both companies have significant manufacturing capacity,” Walmsley added in a separate video message.

“We still have a lot of work to do since this is still at an early stage of development. We believe that if successful, we’ll be able to make hundreds of millions of doses annually by the end of next year,” she said.

The collaboration was applauded by industry representatives as well. 

“Today’s announcement is an illustration of the biopharmaceutical industry’s strong sense of responsibility to act together and live up to its COVID-19 commitments, which include working in a concerted manner to increase industry’s manufacturing capabilities and willingly share available capacity to ramp up production once a successful vaccine or treatment is developed”, said Thomas Cueni , Director General of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) told Health Policy Watch.

The recent alliance aims to combine Sanofi’s protein-based vaccine with GSK’s adjuvant technology. Adjuvants are commonly added to protein-based vaccines to boost the immune response to the vaccine, allowing the vaccine to be more effective at lower doses. This makes the vaccine easier to mass produce. 

The companies have entered into a Material Transfer Agreement to enable them to start working together immediately. Definitive terms of the collaboration are expected to be finalised over the next few weeks.

If the new vaccine candidate is successful in Phase 1 Clinical Trials planned for late 2020, it will be available in the first 6 months of 2021, says the joint Sanofi-GSK press release.

The companies have established a Joint Collaboration Task Force for the project, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. The Biomedical Advanced Research and Development Authority (BARDA), an arm of the US Department of Health and Human Services (HHS), has already committed to funding part of the Sanofi vaccine’s development.

Image Credits: Heather Hazzan, GSK.

[Unitaid]

Geneva, Switzerland (14 April 2020) – Unitaid marked the first World Chagas Disease Day with the release of a comprehensive report on how to better confront the potentially deadly parasitic infection that strikes hardest among Latin America’s poor and marginalized.

It was on this date in 1909 that a Brazilian doctor, Carlos Chagas, diagnosed the first case of what was to be called Chagas disease.

Unitaid is also developing an initiative to help eliminate mother-to-child transmission of Chagas disease as part of its mandate to improve maternal, newborn and child health.

“Unitaid was created to speed equitable access to innovative health solutions, and we are thrilled to join global efforts against this insidious disease,” Unitaid Executive Director a.i. Philippe Duneton said. “Access to simpler and more affordable test and treat tools will help end the suffering Chagas causes, and cut costs for families and health systems.”

Unitaid’s work aligns with global health plans that call for eliminating Chagas disease as a public health problem by 2030.  Currently, only an estimated 7 percent of people with Chagas disease get diagnosed, and only 1 percent receive effective treatment.

Unitaid’s just-released report, Technology and Market Landscape for Chagas Disease, maps out the diagnostics and treatments that are in use now and identifies innovations that could improve upon them. The report also examines market barriers that could be removed to make way for better tests and treatments.

Unitaid’s upcoming investment to tackle mother-to-child transmission seeks to address some of these challenges, notably the lack of diagnostic tools and medicines in primary health care clinics. At least two million women of child-bearing potential are chronically infected with ‘Trypanosoma cruzi’, but active screening and optimal treatment can prevent transmission to their babies. In addition, early detection of infection in infants can greatly reduce the number of hospitalizations and deaths related to Chagas disease.

Transmitted by the blood-sucking triatomine bug, Chagas disease (American trypanosomiasis), slowly brings on cardiac, neurological and digestive problems. Up to 7 million people are thought to be infected with it, 75 million people are considered to be at risk of infection and about 10,000 die from it annually. In Brazil, Chagas disease causes more deaths than any other parasitic disease, including malaria.

In the last decades, the disease has moved from the countryside to urban settings, and is now found outside the borders of the 21 Latin American countries where it is endemic. Cases now appear in places such as the United States, Europe, Canada, Japan and Australia.

For more information: Gloria Vinyoles | 41 79 121 18 65 | vinyolesg@unitaid.who.int

Image Credits: Unitaid.

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

WHO Director General Dr. Tedros Adhanom Ghebreyesus said on Monday that the relationship between WHO and the United States is “very good” and that, despite the recent maelstrom of criticism by President Donald Trump over WHO’s handling of the COVID-19 crisis, he hoped that funding from the USA will continue. 

“I hope the funding to WHO will continue. And the relationship we have is very good. And we hope that this will continue,” said Dr Tedros at a press briefing.

The WHO Director-General was responding after a rash of remarks late last week by Trump, other key White House figures and allies over the agency’s handling of the crisis, which Trump and some of his political allies have described as “China-centric.”  There have been suggestions, including from Trump, that the US might consider suspending its contributions to the organization, and Congressional Republicans have demanded more documentation about key exchanges between WHO and China over issues that arose in the early days of the outbreak, such as whether the virus could be transmitted, person-to-person. 

The USA is the biggest contributor of funding to the WHO and has provided US$ 400 million to the Organization in 2019, which was ten times more than China. 

Meanwhile, however, WHO received a big boost from another major donor country, the United Kingdom. The announcement of a contribution of £ 200 million came just after Prime Minister Boris Johnson was discharged from a hospital where he was treated in an intensive care unit for several days, crediting the British National Health Service (NHS) for “saving my life”. Dr. Tedros welcomed this “generous support” and urged other member countries to follow the UK’s initiative.

Countries Need To Be Wary of Lockdown “Exit Strategies” Even In Places Where Outbreak Has Stabilized 

Countries planning to lift their lockdowns must do so carefully and gradually, urged Mike Ryan, Executive Director of the WHO’s Health Emergencies Programme, at the press briefing. He underlined this as a key principle even as outbreaks have stabilized in a “pretty consistent way” for a number of European countries.

“Lockdowns can be lifted in certain strategic areas, maybe where there’s lower incidence. But it does have to happen slowly, it does have to happen in a very controlled manner. And it is important that the community understands this,” said Ryan. 

As countries begin to open up again, they must maintain aggressive surveillance, testing and community engagement to keep the outbreak at bay. “We need to have a much more stable exit strategy that allows us to move carefully and persistently away from lockdown. And the only way to do that is to have fully empowered communities and a fully activated public health architecture and to the strengthen health system”, said Mike Ryan.

It is also “really important” that the lifting of these measures doesn’t happen “all at once all over Europe”, added Maria Van Kerkhove, Technical Lead for the WHO’s Health Emergencies Programme, as this may trigger another outbreak wave.

Huge Unknowns About Coronavirus Contagion Period & Immunity Gained After Illness  

3D print of a spike protein of the SARS-CoV-2 virus

Scientists still don’t have a full picture of the immune response to COVID-19, and that is one of the other issues confounding policymakers as they try to make decisions about exit strategies.

People infected with COVID-19 produce antibodies, but it is unclear whether these antibodies confer immunity, and for how long, Ryan pointed out adding, “The data is quite limited.”

“Some individuals had a strong antibody response. Whether that antibody response actually means immunity is a separate question”, said  Kerkhove referring to a new study from Fudan University in Shanghai that has not been peer-reviewed yet. The study, which compared antibody responses of almost 200 patients, showed that some people infected with COVID-19 may not develop any antibodies at all.

Yet another big knowledge gap centers around the time during which people carrying the virus may transmit it to others, Kerkhove said.

Although most people infected with COVID-19 develop symptoms within five days, scientists do not know whether patients are contagious for several days or weeks. Polymerase Chain Reaction (PCR) tests, the lab-based gold standard for diagnostics, suggest that contagion could last several weeks. However, just because people with the mild disease test positive for several weeks does not necessarily mean that they are still contagious, said Kerkhove.

“We don’t have the full picture,” she said, “What we need is much more data from countries to actually be able to say, how long is someone contagious.” 

In light of limited testing capacity and unknowns about the length of time a person can be contagious, individuals in home isolation should stay at home until their symptoms resolve, and even continue isolating themselves for another two weeks after that as well, recommended Kerkhove.

“What we recommend right now is that those individuals are in home isolation, if they can’t be isolated in a medical facility, until their symptoms resolved, plus an additional 14 days”.

More data is also urgently needed to understand if the immune response is different between patients with mild and severe COVID-19, especially in those with severe infection that have recovered, added Kerkhove. Such studies will help researchers determine what type of immune response helps a patient clear SARS-CoV-2 safely and effectively from their body.

Many of the deaths associated with COVID-19 may also be due to an overreraction of the immune system, rather than the the virus itself, suggests a study published late last month. As part of the immune reaction, so-called “cytokine storms” can lead to an excess amount of immune cells piling up in the airways and blocking them off, leading to death.

WHO Softens Position on Masks 

Wearing masks to protect from COVID-19 in Nigeria (Photot: @CRSPHCDA1)

As mask use in the general population has gained momentum in various countries, including not only Asia, but the USA, eastern Europe and Israel, the WHO officials at the briefing expressed a more positive line on the practice, saying that they could support public use of masks as part of a comprehensive strategy. Previously, WHO’s Emergencies team had said mask use in the general population was unnecessary, except among people who are symptomatically ill, or caring for other sick household members.  

“The WHO will support countries who wish to implement a more broad based strategy of mask use “as long as it’s part of a comprehensive strategy”, said Ryan.

“[The comprehensive strategy] includes physical distancing. It includes hand hygiene. It includes respiratory etiquette. It includes staying home if you’re unwell. It includes cases being isolated confirmed cases being isolated. It includes contacts being in quarantine, and it includes following the directives of the national government”, added Kerkhove.

WHO has also stressed that masks, when worn or used improperly, can still lead to transmission of the virus.  This is supported by a recent study that found large quantities of SARS-CoV-2 can accumulate on masks. The study, which was published last Friday, recommends adequate desinfection of masks before discarding them.

“There are issues around wearing those face coverings and disinfecting those face coverings and disposing of those face coverings or masks”, said Ryan. 

But for those who know that they are ill, masks are not an alternative to self-isolation, emphasized Ryan. “We don’t want people to think that putting a mask on is the same as staying home and reporting the fact that you’re sick to authorities”, he said.

The WHO’s policy on broad-based mask use has been tweaked amid growing recognition that social isolation is unrealistic in some settings and communities, especially those in developing countries with high population densities, said Kerkhove at the press briefing. In addition, in places where transmission of the virus is high, many people who are in fact ill and contagious may be unaware of their status, experts have said. 

Total cases of COVID-19 as of 10:20PM CET 8 April 2020, with active case distribution globally. Numbers change rapidly.

Image Credits: NIAID, Cross River State Primary Health Care, Nigeria .

Photo: D Sharon Pruitt

Although there have been suggestions that warmer weather might lead to the waning of the COVID-19 pandemic in the Northern Hemisphere, a new study published by the United States National Academy of Sciences has dashed some cold water on that hypothesis, saying that available data on diease spread has so far failed to show strong seasonality.

The preliminary analysis by the National Academies’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats said that the number of well-controlled studies showing reduced survival of the coronavirus in elevated temperatures and humidity is small, and urged caution not to over-interpret results. While some data, particularly from laboratory studies, provide evidence supporting seasonality, the researchers note that these are not necessarily representative of the natural environment and that multiple countries currently in their summer season are experiencing significant volume of transmission,

Even if warmer temperatures are less favorable for COVID-19, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” the experts wrote.  Some countries in warm climate are also experiencing rapid virus spread, the experts added, so that “a decrease in cases with increases in humidity and temperature elsewhere should not be assumed.”

The report also notes that neither of the other coronaviruses that have recently leaped from animals to humans, Severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), nor the flu strains of previous pandemics, have shown a seasonal pattern.

The study evaluated available observational epidemiological data as well as laboratory experimental data, including studies both in China and other countries. Further study is required to better characterize the virus’ transmission patterns, reported the Univeristy of Minnesota Center for Infectious Disease Research and Policy. 

COVID-19 Cases in Spain Rise Once More

After a week of decreasing daily COVID-19 incidence, Spain once more reported elevated numbers on 3 consecutive days. Today, Spain reported 5,756 new cases, bringing the national total to 152,446 cases, including 15,238 deaths (683 new), reported the Johns Hopkins Center for Health Security. Italy reported more new cases than the previous day (3,836 compared to 3,039), but the daily incidence remains below 4,000 for the third consecutive day after exceeding that number for nearly 3 weeks. Italy is reporting a total of 139,442 confirmed cases, and 17,669 deaths.

Meanwhile, while US President Donald Trump expressed hopes that the US could “reopen again soon” experts were more reserved in light of the continued increase in US cases, with some 30,000 more infections reported in the US over the past 24 hours, 10,000 more than on the day before.

In South-East Asia, cases also continued to rise in India, in partvcular, which has reported more than 500 new cases a day, over the past 10 days, for a 300% increase, There are now 6,412 cases in the country, according to the official India Ministry of Health and Family Welfare data.

Meanwhile, WHO Director General Dr. Tedros Adhanom Ghebreyesus brushed off recent criticism of WHO’s response to the COVID-19 crisis, which US President Donald Trump on Tuesday tweeted was “very China centric.”  At a later White House briefing Trump repeated his charge that WHO had been too soft on China’s early management of the emergency, and suggested that US funding to the organization would be re-examined. Trump also criticized WHO’s strong opposition throughout January and February to the imposition of travel restrictions to stop the spread of the virus, saying that the Organization should have recommended restrictions much earlier, which the US later adopted on unilaterally followed by countries around the world.

At a WHO press briefing on Wednesday, the WHO Director General urged political leaders not to play politics with the coronavirus emergency, adding: “why do I care about being attacked when people are dying.”

    Cumulative and active cases. Numbers change rapidly.

-Updated 4 April, 2020

Image Credits: D Sharon Pruitt.