United Nations General Assembly hall in New York City

The UN General Assembly approved a resolution Monday night calling for accelerated scientific cooperation and global coordination to hasten the “rapid development, manufacturing and distribution of diagnostics, anti-viral medicines, personal protective equipment and vaccines” needed to fight the COVID-19 pandemic.

The resolution, approved in a virtual poll, also called on countries “to immediately take steps to prevent … speculation and undue stockpiling that may hinder access to safe, effective and affordable essential medicines, vaccines, personal protective equipment and medical equipment.”

Drafted by Mexico and co-sponsored by about 170 countries, the Resolution mandates UN Secretary-General Antonio Guterres to work with the World Health Organization “to identify and recommend options” to ensure timely and equitable access to testing, medical supplies, drugs and future coronavirus vaccines for all in need, especially in developing countries.

The resolution was welcomed by a cross-section of bio-pharma and medical technology industry associations, which banded together to highlight their support for more international collaboration, including between public and private sectors, in the quest for treatments.

“Our organizations believe that coordinated, inclusive, and multi-stakeholder action is the only possible solution to mitigate the impact of this unprecedented global health emergency,” said the statement by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the International Council of Biotechnology Associations (ICBA), the Global Medical Technology Alliance (GMTA), the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA), and the Global Self-Care Federation (GSCF).

“COVID-19 is teaching us a crucial lesson: facing any global health challenge, in particular one of such unprecedented scale, requires solidarity, truly inclusive cooperation and even closer
efforts to ensuring health systems’ resiliency. As this Resolution calls for United Nations -wide coordinated efforts, we believe that priority should be placed on critical aspects, including
strengthening the global supply chain to support continuity, ensuring effective surveillance mechanisms, fostering strong and adaptable resource capacity within health systems, and
promoting the establishment of procedures for fast evaluation and approval of new health technologies.”

However one civil society group, which has advocated for removing all patent barriers that might hinder broadbased access to COVID-19 therapies, was not as enthusiastic. “The New York UN resolution avoided the elephant in the room, the issue of IP on tests, drugs and vaccines,”  James Love, head of Knowledge Ecology International (KEI), told Health Policy Watch.

The resolution also reaffirms the fundamental role of the United Nations system in coordinating the global response to control and contain the spread of COVID-19 and in supporting the 193 U.N. member states, “and in this regard acknowledges the crucial leading role played by the World Health Organization.”

Notably the United States did not block adoption of the text, despite the fact that U.S. President Donald Trump suspended funding to the World Health Organization earlier this month. He accusing WHO of being “China-centric” in its response to the virus, failing to alert member states about potential human-to-human transmission early enough, and opposing travel restrictions – w which were later widely adopted by countries anyway as the outbreak spiraled into a pandemic.

The vote over the resolution was held remotely since the General Assembly is not holding meetings during the pandemic. Under the rules instituted, the draft resolution is circulated to member states and if any single state rejects the resolution, it is not adopted.

General Assembly President Tijjani Muhammad-Bande announced the approval of the resolution in a letter to the 193 U.N. member states Monday night saying there were no objections to the resolution.

The resolution is the second on COVID-19 approved by the General Assembly.

On April 2, the world body approved a resolution on Global solidarity to fight the coronavirus disease recognizing “the unprecedented effects” of the pandemic and calling for “intensified international cooperation to contain, mitigate and defeat” the virus.

Image Credits: Patrick Gruban.

In characteristically soft-spoken tones, World Health Organization Director General Dr Tedros Adhanom Ghebreyesus issued his strongest rebuttal yet to the recent allegations by United States President Donald Trump that the WHO had hidden information in the early days of the COVID-19 pandemic, or failed to inform WHO member states rapidly enough.

Calling upon his own background growing up in Ethiopia where he saw rampant poverty and lost a brother to disease, the WHO Director General declared “we don’t hide information.”

He also warned the world’s leaders saying that they were “playing with fire” by playing politics with the pandemic.

“Don’t use this virus as an opportunity to fight against each other or score political points. It’s dangerous,” he said.

“This is a tragedy which is already affecting many families. So we don’t hide information,” he added, “Because I know what poverty means, I know what war means, I know what killer diseases mean…. This is a devil that everybody should fight, and for that we need global solidarity, cemented in national unity.”

He added that public health experts remain challenged by the lack of knowledge around the virus and this had also contributed to a slow global response: “It’s a virus that many people still don’t understand. Many countries that are very developed, put [out] the wrong conclusions because they didn’t know it, and got into trouble. 

“And we warned even developed countries saying, ‘this virus will even surprise developed countries.’ It did. It will even surprise wealthy nations, we said that, it’s on record.”

WHO has two permanent US government secondees embedded in its operations, added WHO Emergencies Head Mike Ryan, as well as 15 more US experts who have been seconded since the COVID-emergency erupted, acknowledging the “major contribution US government officials embedded in our outbreak have played since the early days of the operation.” Along with those direct scientific links, he said that all G-7 countries have AI-based intelligence systems that pick up signals on new disease threats and outbreaks.

WHO Sees Turbulent Week of Support & Critique

Dr Tedros spoke after a turbulent weekend that saw both strong signs of support for the WHO, in the form of a US$ 500 million emergency contribution from Saudi Arabia, as well as continued backlash from the United States.

The US hand was evident in the squashing of a G-20 statement of support for the beleaguered global health organization at a virtual meeting Sunday of the Group of 20 most industrialized nations. The terse six-paragraph press release that was finally issued  instead made no mention of WHO whatsoever, vaguely referring to “vulnerabilities in the global community’s ability to prevent and respond to pandemic threats.”  A post-meeting press conference was abruptly cancelled by the chair, Saudi Arabia Health Minister Tawfiq Al-Rabiah.

The original 52 paragraph statement had reportedly expressed “concern about the continuity and lack of sustainable funding” of the WHO’s health emergencies programme, according to an unpublished draft obtained by the Guardian. It urged all donors to invest in the fund, saying “it is far more cost effective to invest in sustainable financing for country preparedness than to pay to the costs of responding to outbreaks.” 

Addressing G-20 leaders, the WHO Director-General urged industrialized countries to loosen their lockdown restrictions with caution, while continuing funding and producing needed supplies for the global response.  He noted that even as new cases are stabilizing in many developed, they are escalating in many countries with weaker health systems. 

“We are looking to the G20 countries to continue to support the global response to COVID-19,” said Dr Tedros, in his published statement, “We echo [South African] President Ramaphosa’s appeal on behalf of the African Union to G20 countries to support African countries with stimulus packages and debt relief so they can focus on fighting the pandemic.

“We call on all G20 countries to work together to increase the production and equitable distribution of essential supplies, and to remove trade barriers that put health workers and their patients at risk.”

G20 Health Ministers meet via video conference to discuss the COVID-19 response.
WHO Narrative On Taiwan’s Warnings 

At Monday’s press briefing, meanwhile, Dr Tedros also sought to set the record straight on one key element of the US allegations – the 31 December email from Taiwan’s Centers for Disease Control, that Taiwanese and US authorities said had been ignored. Although Taiwan said the message had suggested that the virus could be transmitted person-to-person, it was not the first alert about the disease, nor did it specifically indicate that the virus was transmitted via human contact. And it was only one of only dozens of emails that were received by countries requesting clarifications about the first news of the virus spread.

“The one thing that has to be clear is the first email [alert about the novel coronavirus] was not from Taiwan,” he said. “The report first came from Wuhan and China itself – that’s number one fact.”

“The email from Taiwan like other entities, was to ask for clarification,”  he added, noting that it was one of many such queries received from countries. “And they didn’t report any human-to-human transmission.  

“So we didn’t receive a report of the existence of human human transmission from Taiwan on December, 31. We have all the documentation, and the emails we received from Taiwan… like other entities, was to ask for clarification. Nothing else. “

On 11 April, the Taiwanese Ministry of Foreign Affairs retweeted its December 31 message to WHO. The tweeted message from Taiwans Centers for Disease Control stated, that “News resources today indicate that at least seven atypical pneumonia cases were reported in Wuhan, China. Their health authorities replied to the media that the cases were believed not SARS; however the samples are still under examination and case have been isolated for treatment. I would greatly appreciate it if you have relevant information to share with us.””

In a follow-up email to media sent 13 April, Chenwei Ku, Assistant Director of the Taiwanese Mission in Geneva said that while the message did not explicitly refer to person-to-person transmission the words “isolated for treatment” suggested that it was a risk.

“Public health professionals could discern from this wording that there was a real possibility of human-to-human transmission of the disease,” she said. “However, because at the time there were as yet no cases of the disease in Taiwan, we could not state directly and conclusively that there had been human-to-human transmission.”

Moving out of Lockdowns 

As many developed countries looked for ways to move out of lockdowns while new case reports stabilized somewhat, Ryan warned that “moving away from a lockdown” means that countries must “move towards something else.”  That includes communities that “understand how to protect themselves and others, and are willing to continue with the physical distancing and personal hygiene measures.”

Testing is another essential element, but along with testing there is a need to train “hundreds of thousands of contact case workers who can isolate cases and do contact tracing,” he added. Effective quarantine accommodations or measures need to be identified for people suspected or found to be ill.

These measures are particularly important, both Ryan and Emergencies Technical lead Maria Van Kerkhove emphasized, because the most recent serological studies continue to show that a relatively low proportion of the population have antibodies to the SARS-CoV-2 virus that causes COVID-19, meaning that “a large proportion of the population is susceptible.” Among those studies is one from Germany, which showed only about 14% of the population carrying the virus antibodies.

Meanwhile, even if the current wave of outbreaks in the pandemic are brought under control effectively, and a vaccine for the disease is finally developed, the world will still face a massive challenge in delivering immunizations to all of the people who need it.

“We are good at delivering vaccines to children,” said Ryan, but for adults, health systems are ill-prepared.  Ensuring equitable delivery “will require one of the greatest scientific, political, financial and public health operations that we have seen in a generation,” he said. “It must be done with proper stewardship and leadership.”

Novartis Receives US FDA Approval on Phase III trial for Hydroxychloroquine

In developments around Europe, the Swiss-based pharmaceutical Novartis received the go-ahead from the US Food and Drug Administration to conduct a 440-patient Phase III randomized trial of the drug used for lupus, hydroxychloroquine, against COVID-19 disease. The trial, one of the largest to consider the drug so far, will take place in about a dozen sites in the USA. The recently announced clinical trials complements a donation of 130 million doses of the drug by Novartis last month.

We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis in a statement. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”  In addition to hydroxychloroquine, Novartis plans to sponsor or co-sponsor clinical trials to study ruxolitiniband canakinumab – both anti-inflammatory drugs – for hospitalized patients with COVID-19 infections.

Meanwhile, Chinese officials announced they were moving forward with trials for two more vaccine candidates, produced by the Wuhan Institute of Biological Products Co. Ltd., and the Sinovac Research and Development Co – bringing up the total number of vaccine candidates under investigation by China up to 5. In Europe, immunologist Martin Bachmann told Medical News that he hoped his lab at the University of Bern could mass produce enough of a viable vaccine in 6 – 8 months.

Across some 10,000 sequences of the SARS-CoV-2 genome that have been released, the virus appears fairly stable and has not mutated significantly. Thus, researchers can use existing strains of SARS-CoV-2 to develop a vaccine, according to WHO experts.

“The development of a vaccine on current viruses that are available is good,” said Van Kerkhove. “We welcome all work on the development of the vaccine and the as rapidly as safely as possible.”

Switzerland’s top technical universities Swiss Federal Institute of Technology, Lausanne (EPFL), and the Swiss Federal Institute of Technology, Zurich (ETH-Zurich) pulled  out of an European coronavirus tracing App project due to privacy concerns last Friday, Radio Television Switzerland, reported, quoting EPFL president Martin Vetterli. Switzerland plans to lift its lockdown next week.

France plans to triple its testing capacity to 500 000 tests a week by mid-May, said French Health Minister Olivier Véran in a press conference on Sunday. Although France plans to lift its two-month lockdown in mid-May, a complete return to normalcy was far away, French leaders cautioned. Members of the public will ‘probably’ have to wear mask to prevent infections and not all schools will re-open, said French Prime Minister Édouard Philippe. A group of French activists called for an “efficient reorganization” of French trade union Les Entreprises du Medicament (LEEM), which defends the interests of the pharmaceutical industry, in an attempt to improve French medicines production capacity.

In Africa, Chinese billionaire Jack Ma’s foundation sent a third batch of personal protective gear (PPE) for health care workers on the continent,  including 4.6 million masks, 500 000 swabs and test kit, 300 ventilators, 200 000 clothing sets, 200 000 face shields, 2000 thermal sensors, and 500 000 pairs of gloves. The African-based Ecobank said it would contribute some US$ 3 million to governments, the WHO and the private sector to help fight COVID-19.  

Total cases of COVID-19 as of 6:38PM CET 20 April 2020, with active case distribution globally. Numbers change rapidly.
White House Supports Reopening Country After Weekend Protests Over Lockdowns

The White House called for the reopening of sports venues, restaurants, gyms and places of worship, “With federal guidelines in place to protect – not control- American people, it’s time to work together towards it’s time to work together toward reopening America,” said the Tweet. 

Since US President Donald Trump gave initial support to lifting stay-at-home orders, protests erupted in at least six states of the USA over lockdown restrictions, including California, Texas, Ohio, Kentucky, Pennsylvania. Michigan was the first to create a massive traffic standstill around the state capitol building, with many protesters carrying firearms with them. “We want to work. We have paychecks to issue”, said one Michigan protester .  

Speaking on Fox News, Kellyanne Conway, counselor to US President Donald Trump, said, Americans were saying: “I want to get back to work. The governors have the last word on that, but some have been more concerned about controlling the population rather than protecting them,” she said, adding.  “Some of these governors have physically distanced from common sense.  In Michigan, you can basically smoke your grass, but not cut your grass.”

Surge in Singapore 

In the Western Pacific region, however, Singapore was experiencing the biggest surge in cases in a day since the beginning of the outbreak, with 1426 new cases reported today in a press release from the Ministry of Health. Some 99% of confirmed cases are foreigners with work permit residing in foreign worker dormitories, many of which have been declared “isolation areas”. On Saturday, all work permit and S pass holders in construction sector were given stay-home notice.

A nurse in Tehran reported that Iran’s Ministry of Health gave instructions to report coronavirus-related deaths as ‘severe lung infection’ in an attempt to reduce case numbers. US President Trump also cast doubt on Iran’s and China’s numbers.

Indian Prime Minister Narendra Modi has formed a high level task force to develop a vaccine for COVID-19. It will further enable and speed up international efforts in this direction, announced the Bharatiya Janata Party (BJP) today.

Tsering Llamo and Svet Lustig Vijay contributed to this story.

Image Credits: Twitter: @g20org, Johns Hopkins CSSE.

Lady Gaga, the American singer-songwriter, will be curating a massive benefit concert with Global Citizen to fundraise for the global coronavirus crisis. The virtual concert titled, One World Together at Homewill be streamed live on the Global Citizen website and a number of other platforms on 18 April, from 2 – 10PM Eastern Standard Time.

“It is a love letter to our doctors, a love letter to our nurses and other health care professionals who are risking their own lives,” said Gaga in a World Health Organization press briefing on Friday. “This is for the sake of the delivery drivers, grocery store workers, factory workers, public transportation workers, postal workers and restaurant workers doing the same. We celebrate your bravery and your heroism.”

Representing the entertainment industry, Gaga, donning an unusually simple make-up and a crisp white collared shirt in contrast to her usual flamboyant style, extended the community’s commitment towards raising funds for the COVID-19 Solidarity Response Fund while thanking the medical community globally and acknowledging those financially burdened by the Covid-19 pandemic.

Lady Gaga calls into WHO’s 17 April COVID-19 press briefing

Since announcing the concert just two weeks ago, the event has already raised over $50 million for the Solidarity Response Fund, Gaga said on Friday.

Echoing Gaga’s sentiments, Global Citizen CEO Hugh Evans expressed gratitude to all essential workers in the frontline of the pandemic globally and announced the organization’s partnership with the World Health Organization and the United Nations in its proactive commitment and action towards preventing future pandemics by strengthening the global health system and ensuring the equitable access of resources. 

The massive line-up features over 60 major artists and celebrities from around the world. It will include acts and appearances from Sir Paul McCartney, Sir Elton John, Alanis Morriset, Andrea Bocelli, Billie Eilish, Billie Joe Armstrong, Burna Boy, Chris Martin, Sir David Beckham, Sir John Elton, J Balvin, John Legend, Keith Urban, Lang Lang, Lizzo, Maluma, Philip Collins, Priyanka Chopra Jones, Shahrukh Khan, and Stevie Wonder.

The concert will begin livestreaming at 2PM EST (8PM CET) on 18 April at the Global Citizen website, and will be broadcast live on CBS, ABC, Univision. BBC One+ and Viacom stations will broadcast the concert on 19 April and 20 April. Some stations will only be broadcasting certain hours of the event – more details can be found on the Global Citizen website

 

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.

The White House in Washington, DC

As the World Health Organization becomes the target of attack by President Trump, his administration and political allies for its alleged failures in response to the COVID-19 pandemic, the main points of critique are reverberating throughout the media in an escalating cycle.

After a week of mounting criticism, Trump announced on Tuesday night that he had instructed the administration to suspend funding while an investigation was conducted into WHO’s handling of the crisis.

His statement came a little more than 100 days after China first reported the mysterious outbreak of the pneumonia-like virus – even as the agency attempts to contain the pandemic’s spread to vulnerable low-income countries of Africa and South-East Asia.

“The WHO failed in its duty and must be held accountable,” Trump said in the daily White House Taskforce briefing.

While Legitimate evaluation and critique are important, a question that must be asked, however, is whether any shortcomings and mistakes made were uniquely WHO’s? Or is the global health agency also being targeted as the “fall guy” for errors made by its member states, including the United States – which is presently the epicentre of the pandemic.

A more critical question is: would the world be better off without the WHO?

Or is it an agency that we urgently need to coordinate the global response to outbreaks; to synthesize available evidence on effective responses – whether these are at national or hospital level; and to support those countries and health systems that lack sufficient resources to respond on their own?

Main Points of Criticism: Technical Errors & Pressure Politics

Donald Trump speaks at the daily White House Coronavirus Taskforce briefing

Boiled down to the essence, the main points of critique by President Trump, other US administration figures and political allies are running along two lines:

  • WHO leadership bowed to Chinese political pressure in making decisions – refraining from recommendations for more forceful measures such as travel restrictions. And it praised Chinese responsiveness while it avoided criticizing its initial concealment of the outbreak in Wuhan – what Trump described as “China-centric” policies.
  • WHO failed to properly assess and communicate the risks from the COVID-19 virus, particularly in the early days, with respect to a range of medico-technical issues, such as early determinations of whether the virus was being transmitted person-to-person. Trump criticized WHO’s early opposition to travel restrictions, calling it “one of the most disastrous decisions.” Although criticism of the technical decisions, as well, is enmeshed in politics – with Taiwan’s government asserting that it warned WHO early on about the person-to-person risks, only to be ignored.

Had these failures not occurred, the argument goes, the international community — and particularly the United States — would have been spared the scale of human suffering it has experienced. The criticism repeated by President Trump in White House press briefings, and echoed by key political allies, has been coupled with threats to suspend funding to WHO, which amounted to US$400 million in 2019. Congressional Republicans now appear poised to shortly follow up on those threats – even if cooler voices have pointed out that cutting funding during the pandemic might not be the best idea.

Crises and Pressure

It is not surprising that WHO is subject to political attack as deaths from the spread of the pandemic accelerate. National (and more local) political leaders are under great pressure. Their constituents are dying. The role of government is to protect the health and safety of its citizens. People will hold their governments accountable. If misguided actions, or omissions to act, have demonstrably contributed to the scale of suffering, the adverse political consequences loom large.

Almost inevitably, a national government that failed to heed warnings will seek to shift blame. The WHO is a made-to-order target. Its name is enough to suggest that the organization might be held responsible for the consequences of the pandemic. WHO officers and staff are not a voting constituency.

Regardless of what China did or did not do, there is a motive anchored in political expediency to blame the Chinese political leadership as this fits squarely with the Trump Administration’s agenda of portraying China as a bad actor and strategic threat to the United States (while episodically praising it).

The aim here is not to determine definitively what the WHO or China did or did not do. Rather, it is to point out that for his domestic political constituency these are the logical places for President Trump to re-direct responsibility in the COVID-19 crisis. Regardless of facts, there is nothing surprising about this from a political standpoint.

WHO Leadership

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

A substantial part of the US criticism of the WHO is directed toward its leadership and the “real-time” decisions that the leaders, especially Director General Tedros Adhanom Ghebreyesus, have made. The WHO Director General has a margin of discretion in terms of his decision-making. But he relies on input from many technical experts within and outside the organization.

In the case of a pandemic, and under the International Health Regulation, the Director General acts with the advice of an Emergency Committee. The Director General will have received technical input from scientists, logistics experts and so forth from around the world, including the United States, China and Europe. A WHO Director General will be responsible for weighing and balancing the technical opinions he or she receives, but those decisions are based on a body of evidence and opinion. At the same time, any WHO Director General understands that he (or she) will also be judged personally for decisions that were made.

WHO’s Global Role – Its Mandate is Limited by Member States

The WHO, governed by its member states in the World Health Assembly and Executive Board, is the forum where governments and other interested stakeholders discuss and agree upon policy and implementing measures to advance the promotion and protection of public health. The WHO provides the network framework for cooperation to address common challenges. In the counterfactual where there is no WHO – or it is “hypothetically defunded” — what is going to be the alternative? What will be different?

The WHO is deliberately designed with very limited autonomous authority. If a national government — China for the sake of argument — refuses or delays allowing WHO scientists to enter the country, the WHO cannot and does not send paratrooper virologists to stage a raid.

The WHO has powers of persuasion, but those are of debatable strength. In terms of budget allocation, WHO members have also deliberately pursued a system of earmarked funding in recent years that assures national control over the WHO work program.  This has made it difficult for WHO to establish its priorities based on global and regional assessments of public health needs, an issue that Dr Tedros has sought to address. The Gates Foundation is another major source of funding for WHO activities, and due to that, it also plays a substantial role in directing the work of the organization.

Is the new and improved WHO-alternative going to be given “sovereign authority” to act – even against the wishes of member states? Will it have its “own” budget controlled by that sovereign authority? Or, would any new WHO-alternative be even weaker from a political standpoint than “old WHO”?

The critical point is that we need an institution like the WHO because public health concerns such as pandemics are global. What happens in Burundi may very well affect people in Toronto. Leaving aside the ethical questions, high-income countries cannot permanently wall themselves off from the impact of pandemics by sealing their borders, refusing to trade and preventing their citizens from traveling. Or if they theoretically might do that, we would be living in a very different – and poorer – world than the one we are living in today. Only the most radical isolationists might be seeking such a result.

Technical Decisions – Ensuring Feedback Loops & Avoiding Politicization

Against this landscape, much has been made of the decisions made by WHO on medico-technical issues such as its initial uncertainty over whether there had been person-to-person transmission of COVID-19; whether and when to recommend travel bans; whether and when to declare the outbreak a pandemic; and whether to recommend wearing face masks.

These decisions have been made, and continue to be made, in situations of substantial uncertainty.

In hindsight WHO might have more quickly extrapolated the first few reports of facile person-to-person transmission into grounds for a major change in risk assessment. But the grounds were shifting here in light of initial reports coming out of China that human transmissibility was more limited.

With respect to travel bans, at the time that WHO resisted calling for such measures, a  preponderance of public-health specialists were also opining that travel bans were likely to be ineffective because borders are porous; they can restrict critical economic trade; and the imposition of bans may provoke precisely the type of infection-carrier exodus they are trying to prevent. Keep in mind, as well, that this outbreak has posed challenges unlike others seen in the past century, including SARS, Ebola and H1N1.

That said, there is strong evidence that travel bans, when they are used, need to be planned and prepared so that they don’t lead to unintended consequences that facilitate further virus transmission.

This was evident immediately after the United States announced a travel ban on passenger arrivals from Europe. This triggered a wave of departures from European airports, with thousands mobbing European and then US arrival terminals for many hours – creating a fertile ground for the virus to spread.

Travelers at Madrid-Baraja Airport, Spain’s largest international airport. The airport is nearly empty after an initial rush of travelers in mid-March, right after the US enacted travel bans for Europe.

The WHO and other public health authorities will certainly need to revisit the utility of travel restrictions in the wake of the COVID-19 pandemic based on experiences gained.

It is almost inevitable that some decisions made in the course of a pandemic will be in error. Everything is not foreseeable or pre-programmable. The question is not so much whether errors will be made — though obviously this should be kept to a minimum — but how well the feedback loop works so that mistakes are quickly corrected.

Many national (and local) governments, including the United Kingdom as well as large parts of the United States, initially elected to go about business-as-usual, avoiding business and school closures and stay-at-home orders. Once it became apparent that lockdowns of some sort were one of the most effective tools to contain the spread of the virus most of those governments corrected the mistake. The egregious failure is by the government entity that has the “better information” and refuses to act on it.

When the history of the COVID-19 pandemic is written, it is likely that some of the decisions at least initially made at WHO will be assessed as errors. Errors made in the course of a pandemic are likely to cost lives and they cannot be treated lightly. The main thing is that the appropriate lessons should be drawn so that they are not repeated.

The China Question – Did the US Listen to its own Intelligence Services?

Residents in Wuhan buy daily necessities and food across closed fence gates during the lockdown in China.

Perhaps the most politically fraught set of issues goes to the question “what did China know and when did it know it?”

I do not have the answer to that. It is “above my pay grade”. What seems clear based on current reporting is that the US government through various information channels became aware of an outbreak with potentially very severe consequences early on and that President Trump was apprised of this information. The President delayed domestic preparedness, even weeks later assuring the public that the virus was something over which we have “tremendous control”.

If the President chose to ignore information coming from US intelligence services and other presumably reliable sources, what difference would it have made if the WHO (or the Chinese government) conveyed information about person-to-person transmissibility a week or two earlier?

None of this would excuse the Chinese government if it deliberately withheld information critical to the international community at large, but it does go to the heart of the political dynamic within the United States and harsh criticism aimed at China (and indirectly at the WHO). Shouldn’t the United States President have trusted his own intelligence apparatus without confirmation from the Chinese government?

COVID-19 Reaffirms the Need for a Global Health Organization

(left) World Health Organization Headquarters in Geneva (Photo: WHO/P. Virot).
(right) White House in Washington, DC (Photo: Obama Whitehouse Archives)

The WHO was founded because the international community needed a forum where public health issues of collective concern could be assessed and addressed. It was not founded to host political debates and resolve strategic disputes — for which there are alternative fora. The COVID-19 pandemic reaffirms the continuing need for such an organization.

The circumstances of this pandemic argue in favor of increasing funding and strengthening cooperation and coordination mechanisms, not for weakening them.

There are no “perfect” international organizations, just as there are no perfect national governments. Judgments made in real time based on imperfect information will not always be optimal. In the case of the WHO, judgments are based on processes that filter incoming data through a range of scientific experts. A judgment by the WHO Director General may turn out to be incorrect, and it should be corrected promptly. The Director General and senior WHO leadership understand that what is done during an outbreak will be analyzed and assessed by history.

The WHO, however, should not be the place where national governments offload their own errors in judgment made with their own, and perhaps even better, information as well as (at times) resources.

Some countries that were just as vulnerable to the virus as the United States responded earlier, and in different ways, and have been spared its worst consequences. While the WHO is supposed to provide evidence-based guidance to national decision-makers, ultimately it is up to national governments to act – and that is what the WHO has urged them to do, more than anything, from the beginning – to get ready, to be prepared.

Will the US, or leaders of other WHO member states for that matter, acknowledge the mistakes they have made: the failures to prepare hospitals sooner; failures to acquire protective gear; failures to ramp up testing rapidly?

President Trump, like others, made decisions early in the crisis under circumstances of imperfect information – that needs to be acknowledged. The problem for President Trump is that he insists that his instincts are perfect, so that if errors were made they could only have been made by someone (or somewhere) else.

Acknowledging error undercuts a claim to perfection. And President Trump is not alone on the world stage today claiming that kind of instinct.

Director General Tedros has not claimed to be perfect, or to have made perfect decisions. His appeals have largely centered around another theme – solidarity.  He has called on world leaders to put politics aside while countries confront a bigger enemy than each other. That call goes increasingly unheeded. Like COVID-19, the accelerating pathogenic deterioration in international discourse needs to be contained so that the world can confront future pandemic threats with an even more effective WHO.

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Frederick M. Abbott is Edward Ball Eminent Scholar Professor of International Law at Florida State University College of Law, USA. He has served as expert consultant and legal representative for numerous international organizations (including the WHO), governments and NGOs, mainly in the fields of public health, intellectual property and technology transfer, trade, and sustainable development. He is Co-Chair of the ILA Committee on Global Health Law. He served as a member of the Expert Advisory Group (EAG) to the UN Secretary General’s High-Level Panel on Access to Medicines.  http://frederickabbott.com

Image Credits: WHO/Pierre Virot, Library of Congress/Carol Highsmith, White House/D. Myles Cullen, Wikimedia Commons: Nemo, Wikimedia Commons: Painjet, WHO/P. Virot; Obama Whitehouse Archives .

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?

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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.