The vaccine developed by Oxford University and AstraZeneca is the only one to have both been secured by COVAX and already approved by a national regulatory authority (the United Kingdom) in a transparent review process.  

The World Health Organization’s (WHO) COVID-19 vaccine access platform, COVAX, is geared up to deliver vaccines to “far more” than 20% of member states’ populations beyond 2021, Dr Kate O’Brien, the body’s director of vaccines, told its Executive Board meeting on Tuesday.

She was responding to concerns and criticisms expressed by member states at the EB’s opening session on Monday about the ability of COVAX to deliver vaccines to member states that have not been able to purchase them on their own.

As Austria’s Dr Clemens Martin Auer, told the meeting: “COVAX is slow. It has not closed a crucial number of contracts, and therefore, substantial numbers of vaccines are not being timely delivered to member states.”

Distribution datelines for COVAX delivery of 2 billion vaccine doses in 2021, based on data available on 7 January 2021.

Auer, who is also the co-chair of the EU’s vaccine procurement group’s board, said that the EU group had been meeting up to three times a week since June to put together a broad portfolio of vaccines, but the management of COVAX lacked transparency about its procurement programme.

“We did do our homework within the EU to secure the needs for 450 million EU citizens to have access to urgently needed vaccines. We were sceptical that GAVI had the means and the capabilities to fulfill its tasks to negotiate the necessary contracts and to secure the needs of our citizens. 

“The proposals that GAVI negotiated side-by-side with the EU with the producers was rejected by the management of GAVI COVAX. So I would like to express the clear statement that the EU and its member states are exercising their global solidarity and we are the single largest donor when it comes to supporting GAVI COVAX facility.” 

Auer also asked why the COVAX management had initially decided to exclude the mRNA vaccines being produced by Pfizer and Moderna, which have been the first to receive European and American regulatory approvals; what COVAX’s delivery plans were and how many vaccine doses member states could expect?

Dr Bruce Aylward, Senior Advisor to the Director-General, reported that GAVI has “145 million doses contracted for release during the first quarter of this year.”

Bruce Aylward, WHO Senior Advisor to the Director General, at the Executive Board session on Tuesday.

Timing depended on countries’ regulatory support, continued financing of COVAX and co-operation from countries and entities that have large bilateral vaccine deals “because choices have to be made as to which contracts get served in which order, and the dose sharing that we mentioned yesterday,” added Aylward, who represents the WHO at GAVI. 

“There is no question that we can achieve the Director General’s vision of all countries vaccinating their highest risk populations by World Health Day [7 April], which is only a couple of months away, but to achieve that ambition will require a new level of cooperation and coordination as we go forward,” said Aylward.

“Any suggestion that COVAX is not operational has to be scrutinised, as the facility is operational,” stressed Aylward.

WHO Now Examining Indian, Russian & Chinese Vaccines – While Moderna & Pfizer Hold Back

One key holdup with COVAX, in fact, appears to lie in the mismatch between the vaccines for which COVAX has arranged pre-order deals – and those that have received approval so far by WHO or another strict regulatory authority as safe to use. 

Brand names of doses secured by COVAX that would be available for delivery – however only following WHO approval of AstraZeneca, Serum Institute of India and J&J vaccines.

So far, the AstraZeneca/Oxford University vaccine is the only one to have both been secured by COVAX and already approved by national regulators.  

Another key COVAX product, a vaccine candidate by Johnson & Johnson has not yet received US or European regulatory approval. Yet a third, by Sanofi/GSK lags even further behind. 

Meanwhile, as Auer pointed out, COVAX has either been unable or unwilling to secure deals with the other two leading pharma companies that are rolling out millions of mRNA vaccine doses, Pfizer and Moderna. 

And Moderna has not yet even submitted a full dossier on its product for WHO review – despite the fact that it has been approved in Europe, the United Kingdom, the United States and Switzerland.  

In the interim, WHO is in the process of reviewing vaccine candidate submissions by Indian, Chinese and Russian counterparts – which are eager to get the Organization’s seal of approval – and market them independently to the dozens of countries that have already submitted pre-orders. 

In the case of the Indian vaccine, a generic version of the AstraZeneca/Oxford vaccine technology, WHO manufacturing approval would also clear the way for offering it through COVAX – where it comprises the largest single pre-order by the facility. 

“We have full dossiers from three other drug companies right now, Sinopharm, Sinovac, and the Serum Institute of India and they are under assessment,” said WHO’s Dr Mariangela Simao, Assistant Director-General for Access to Medicines, who said the real time status of WHO review and approval for all vaccines can be tracked on the WHO’s website. 

“We have a mission in China right now, to do the inspections in Sinopharm, in Sinovac,” she added.

Mariângela Simão, WHO Assistant Director General of Access to Medicines and Health Products, at the morning session of the EB meeting on Tuesday.

She added that she expects more information on Russia’s Sputnik vaccine next week following a meeting with the vaccines developers at the Gamaleya Research Institute. 

“For Russia, we are still waiting for additional information from Gamalaya, we have a meeting with the team next week.”

She said that WHO is also awaiting further information from the Republic of Korea, where the firm SK Bio is set to produce the AstraZeneca vaccine under a generic license – using the core vaccine technology approved by the United Kingdom. 

Among all of the vaccines in late stage trials or already being rolled out, only the Pfizer vaccine has actually received the full and final WHO seal of approval – although so far there is no COVAX pre-purchase agreement with Pfizer – and the vaccine requires ultra cold storage conditions.

Mixed Results from Chinese and Russian Phase 3 Trials So Far 

While WHO approvals would also be reassuring for the many countries that have already placed orders for the Chinese and Russian vaccines – there have been diverse reports so far about their efficacy. 

Sinovac’s results have generated the most concern. In the results of a Phase 3 trial in Turkey, released late in December, the company proudly announced an efficacy of 91.3%, but subsequent results in other countries have been much less impressive, showing 78% efficacy in one Brazil trial, 65.3% in Indonesia – and only 50.3% in the most recent Brazilian trial of 12,000 healthcare workers. 

That barely makes the 50% mark for the minimum efficiency standards set by WHO  and the FDA – although Sinovac said that the trial of healthcare workers was biased because they would be more intensively exposed to the virus than the general public. 

The Sinopharm vaccine, co-developed by the Beijing Institute of Biological Products, has reportedly yielded an efficacy result of 79.3% in China and 86% in another Phase 3 trial in the United Arab Emirates – although again these have yet to be reviewed independently. 

Over 60,000 volunteers from 125 countries, including Morocco and Peru, are still taking part in late stage clinical trials, said Sinopharm.

Of the three, the Russian Sputnik vaccine claims the highest overall efficacy rate of more than 90%, just trailing behind Pfizer’s and Moderna’s mRNA vaccines by a few percentage points, according to interim findings from late-stage trials in Russia. 

But once more, while the WHO review is still pending, the data has yet to be published in a peer-reviewed journal or reviewed transparently by a regulatory authority.   

Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 14 January.

 

–Svet Lustig Vijay contributed to this story

Image Credits: John Cairns, WHO, WHO.

WHO Director General Dr Tedros Adhanom Ghebreyesus Tedros makes opening remarks at EB148

The world is “on the brink of a catastrophe and moral failure – and the price of this failure will be paid with the lives and livelihoods in the world’s poorest countries,” declared WHO Director General Dr Tedros Adhanom Ghebreyesus, in his harshest rebuke to date of both countries and the pharma industry for failing to roll out out life-saving COVID-19 vaccines more equitably across the world. 

Speaking on the opening day of what is set to be a marathon session of WHO’s Executive Board, the WHO Director General noted that “more than 79 million doses of the vaccine have now been administered in at least 49 higher income countries, while just 25 doses have been given in one low income country.” 

While some WHO member states, including India’s Minister of Health Harsh Vardhan, EB Board Chair, framed the vaccine roll-outs now underway as the glass “half full” in his opening remarks – which coincided with the launch of India’s own vaccine’s campaign set to become the largest in the world, the WHO DG was not so upbeat. 

Rather Dr Tedros expressed the deep rumbles of dissatisfaction echoing among senior WHO officials over the way in which the WHO co-sponsored COVAX facility is being sidelined in the rush by countries – and even blocs of countries – to arrange their own vaccine deals. In fact that rush, which began with the United States, the European Union and other rich countries, now includes South Africa, Brazil, India, and most recently the African Union – which announced last week that it had secured pre-orders of some 270 million vaccine doses from manufacturers for its member states, outside of the COVAX framework.   Earlier this month, South Africa also announced that it had arranged for its own vaccine purchases, following on from India and Brazil. 

Countries and Companies Continue to Prioritize Bilateral Deals

“Some countries and companies continue to prioritize bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue,” said Dr Tedros, noting that some 44 such deals were signed last year. 

“The situation is compounded by the fact that most manufacturers have prioritized regulatory approval in rich countries where the profits are highest rather than submitting full dossiers to the WHO,” he added.  

The lack of communication from pharma producers, he warned, could also delay WHO approval of vaccines to be rolled out through COVAX: “This could delay COVAX deliveries and create exactly the scenario COVAX was designed to avoid with hoarding a chaotic market, an uncoordinated response and continued social and economic disruption.”

The WHO Director General called on countries and pharma producers to “change the rules of the game in three ways,” including by countries transparently reporting to COVAX the nature of their bilateral deals – “including on volumes, pricing and delivery dates.” 

He also called on countries with large vaccine orders to “share their own doses with COVAX, especially once they have vaccinated their own health workers and at risk populations, so that other countries can do the same.”

And, he called on pharma vaccine producers to “provide WHO full data for regulatory review in real time to accelerate approval… to prioritize supplying COVAX rather than new bilateral deals” as well as to allow countries to share any extra doses with COVAX. 

“My challenge to all member states is to ensure that by the time World Health Day arrives on the seventh of April. COVID-19 vaccines are being administered in every country, as a symbol of hope for overcoming, both the pandemic and the inequalities that lie at the root of so many global health challenges,” said Tedros. 

India’s Health Minister More Upbeat  
Indian Minister of Health and Social Welfare Harsh Vardhan presiding at WHO EB 148

While the WHO Director General’s comments certainly reflect the frustrations being experienced by people in many countries who are watching vaccine distribution campaigns get underway among wealthier neighboring states, India’s Vardhan cast a more positive light on the progress seen so far in his opening remarks at the EB:

“Scientific capabilities raced against time and delivered on the promise of a vaccine in the shortest possible time in history,” declared Vardhan, who is the EB chair. “While 2020 was the year of science, 2021 shall be the year of global solidarity and survival,” he forecast optimistically.

“COVID-19 vaccines are being successfully produced across many countries, a tech investment boom is being witnessed, and digital technologies are being adopted. All of this is combining to raise the hope of a new era of progress. I want to express utmost optimism that this year the crisis caused by the COVID19 pandemic shall be mitigated and successfully reversed through committed political leadership and sustainabled global cooperation and solidarity,” said Vardhan, adding that the “COVID-19 vaccines offer a real hope – but that hope needs to reach everyone… therefore we must ensure fair and equitable distribution of the COVID vaccine.”

IFPMA – Concerns Over Speed of Access “Potentially Misleading”

Meanwhile, concerns over the lack of speedy access to coronavirus vaccines to low- and middle-income countries (LMICs) “are potentially misleading and might hinder rather than help this unprecedented effort of global collaboration and solidarity,” said the head of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Thomas Cueni, in a lengthy response to the WHO DG’s remarks. 

“Governments around the world – in industrialized as well as developing countries – have moved overnight from concern about vaccine hesitancy to high anxiety at rolling out the distribution. The political urgency is understandably, it is important recall that the roll-out of approved COVID-19 vaccines is just weeks old. In that time, events have unfolded swiftly, with a couple of other vaccines gaining approval and more to follow. 

“While there is no room for complacency, it is important to note that this is the first global-health emergency in which new vaccines are being rolled out to LMICs at about the same time as in richer ones,” said Cueni – drawing a sharp contrast with other pandemics, where it took years for vital health products to reach poor countries.

Executive Board Packed Agenda Addresses COVID Directly and Indirectly

Much of the ten-day governing board meeting will focus on debates and a flurry of initiatives that are a product of the COVID-19 pandemic’s shockwaves. Beyond the optics and the politics, the quality of debate may be a test case for whether the 34-member EB, in its current alignment representing all six WHO member state regions equally, can regain its past lustre as a technically-focused board – or also requires more serious reform in the wake of shortcomings highlighted by the pandemic – as some critics have suggested.  

Items on the table will include, an exhaustive review of WHO’s emergency response operations in general, and its COVID-19 response more specifically. 

There is also an initiative by some 46 member states for more far-reaching reforms in WHO’s emergency powers and response capacity – looking toward a formal resolution to be submitted for approval at the May World Health Assembly.

The EB will also consider a WHO request for a nearly 20% increase in its operating budget to fill out the many performance gaps that have been uncovered in the course of the pandemic; a new framework to examine how to put WHO’s shaky finances on a more sustainable footing; and foster a more efficient Organization through a series of WHO administrative reforms. 

Along with that, there are a host of other core WHO activities, initiatives and issues, now being re-examined through a COVID “lens.” These range from topics like patient safety and medicines access – to non-communicable diseases and mental health.   

Improving WHO’s Emergency Response
Even as high-tech vaccines are rolled out in some countries, other essential COVID-19 supplies like oxygen remain in short supply in many others, notes the report by the Independent Panel for Pandemic Preparedness, under EB review. this week

Responding to the shortcoming already identified in WHO’s often delayed and wavering responses, the European Union, United States, Canada, Australia and Japan, are among the 46 countries seeking an EB mandate to develop a reform-minded WHA resolution that would sharpen WHO’s emergency response capacity. Behind the scenes, the resolution’s backers want to see much stronger enforcement mechanisms built into the legally-binding International Health Regulations that WHO administers – requiring countries that identify a new disease outbreak or pathogen risk to report on it more transparently and promptly – and enabling stronger action if they fail to do so. The proposal would be anchored in the findings of three independent investigative committees currently underway, the initiatives sponsors, led by Australia and Canada state.

The first gleanings of one such review by the Independent Panel on Pandemic Preparedness and Response will also be under the spotlight at the meeting. The review by an expert team led by the former prime ministers of New Zealand and Liberia concludes that the global pandemic alert system was “not fit for purpose” and the WHO was “underpowered” to do the job expected of it. (See related Health Policy Watch story)

NCDs, Mental Health & Patient Safety – Also Being Examined In the COVID Lens

Other items on the marathon EB agenda include a wide range of items relating to WHO’s pre-pandemic “Triple Billion” programme of work for 2019-2023, which also aims to improve the health of 3 billion people worldwide through wider access to universal health coverage as well as more action on preventive health issues, including social and environmental risks, such as poor diets, physical inactivity, and air pollution. But these items, as well, are being looked at with new eyes in light of the pandemic.   

For instance, a World Health Assembly proposal for a Global Action Plan on Patient Safety 2021-2030  states: 

“Patient safety issues such as personal protection, health worker safety, medication safety and patient engagement have become key areas of the COVID-19 response globally. Patient safety interventions must be urgently implemented in order to respond effectively to this global public health emergency of unprecedented scale. Such interventions are also needed to improve preparedness to respond to such challenges in the future.”  

The EB will also be asked to consider updating WHO’s 2013 Global Action Plan for the prevention and control of noncommunicable diseases, with one eye looking through a “COVID” lens – which saw the virus hit hardest against those with other chronic diseases. The updated action plan, which targets risks such as unhealthy diets, physical inactivity, smoking, alcohol consumption and air pollution, also would now include a stronger emphasis on mental health. It would be extended to the year 2030.

Transparency of Medicines Markets & Local Medicines Production 

The transparency of medicines markets and effective access to treatments for cancer and rare and orphan diseases, is another key topic on the EB agenda – resuming discussions over an earlier South African proposal to expand access to cancer treatments and another proposal on rare and orphan diseases by Peru, which the WHO had deferred until 2021. Linked to that, the EB willl also review the broader topic of medicines and vaccines access, in light of a WHO resolution on transparency in medicines markets, which was approved by the World Health Assembly in 2019. 

In another COVID-inspired move, some EB member states also are reportedly preparing a WHA resolution that aims to strengthen local production of medicines, vaccines and other health products, according to a Zero draft of the proposed resolution, obtained by Health Policy Watch. This has surfaced as an issue in light of the severe supply chain interruptions seen over the past year as a result of the pandemic – which left countries rich and poor facing dire shortages of basic medicines  – from antimalarials in some parts of Africa  to certain common antibiotics in Europe. 

Still other issues being considered involve WHO’s actions to address longstanding problems with fake and substandard medicines and a plan for operationalizing the new “Immunization Agenda 2030” that was approved by the World Health Assembly in August 2030. Both issues are even more important now, in light of the rollout of COVID vaccines underway, and the ongoing quest for reliable treatments. 

WHO Proposes 20% Budget Increase for 2022-2023
WHO proposal to Executive Board for some US $ 447 million in new allocations for 2022-23

A proposal to sharply increase the WHO budget for 2022-23 by nearly 20% or US$447 million is also on the table, raising the two-year budget level to US$4.478 billion.

A big chunk of the added funds would go to strengthening WHO capacity at the country level. WHO also promises to use the funds to integrate the “lessons learned” from COVID into other WHO initiatives; and “mainstream” WHO polio eradication teams – which have often serviced as the “backbone” of WHO vaccine support overall for developing countries – into other functions: 

“In the past, because of limited resources, the human resources and operational infrastructure built through the polio programme has been the backbone of the WHO Secretariat’s technical and public health operational support to countries,” states the budget proposal, “this proved to be critical in WHO’s effective emergency response in immunization campaigns and in surveillance, especially in fragile, conflict-affected and vulnerable settings.”

Under the proposal, rather than staff positions being cancelled in the phase-out of polio activities, polio eradication teams would be reassigned to other functions that, de facto, they already perform anyway, supporting overall immunization goals and general primary health care provision.  

A companion proposal to the budget would establish an intergovernmental working group on Sustainable Financing for WHO. The working group would examine ways to ensure more stable contributions from member states or other sources – easing the reliance on unpredictable  voluntary contributions from member states and other donors for many core programme activities.  The reliance on such contributions is widely acknowledged as a factor leading to gaps in more strategic, long-term Organizational staffing.    

WHO Reform

The EB will also consider advancing a controversial proposal to curtail formal presentations by civil society and other non-State actors at official WHO meetings, including the EB and the World Health Assembly – while facilitating new fora for technical exchanges with WHO technical teams and WHA member states. Civil society groups have objected to the proposals – saying that the new venues for interaction will not be as fruitful since they are outside the formal channels where dialogue with member states takes place. Nonetheless, the EB proposal suggests the approach be tested at the 74th World Health Assembly in May. Other reform proposals would sunset nearly 50 WHO resolutions that are more than six years old – and which WHO argues have since been replaced by other initiatives. The sunsetting would cover resolutions as wide ranging as health responses in nuclear war to the elimination of tropical diseases – which still often entail bulky reporting requirements, WHO says. A more systematic rationale for the declaration of World Health Days is part of yet another reform proposal.

Image Credits: WHO, Independent Panel for Pandemic Preparedness – Second Progress Report. .

Johnson & Johnson vaccine research laboratory. The J&J vaccine is one of the COVID-19 vaccines in the pipeline that WHO’s COVAX facility is planning to procure, but COVAX urgently needs US$ 8 billion to cover its commitments, says WHO special adviser Dr Bruce Aylward.

“Escalating bilateral deals” between pharmaceutical companies and World Health Organization (WHO) member states have complicated the global body’s vaccine delivery platform, the COVAX Facility, a number of top WHO officials told the WHO’s Executive Board yesterday in the opening day of the  EB’s 148th session, which focused largely on the pandemic.

“Countries with bilateral deals are urged to be transparent with COVAX so we know what vaccines are going where and we can be sure the unserved are getting served rather than some countries getting double served,” reported Dr Bruce Aylward, special adviser to WHO’s Director-General, urging wealthier countries to ensure that COVAX gets access to the vaccines.

“The unmet demand now for vaccines, evolving viral mutations and escalating bilateral deals, all require us to adjust our strategy and needs for 2021,” Aylward stressed, flagging that while COVAX is ready to distribute vaccines it urgently needs at least US$8 billion to cover its current commitments.

A brand new report released this week by the Independent Panel for Pandemic Preparedness and Response, however, has made a number of scathing observations about the global handling of the pandemic by countries as well as WHO, including that the response has “deepened inequalities”, the global pandemic alert system “is not fit for purpose”, and that WHO has been “underpowered to do the job expected of it”.

The Independent Panel for Pandemic Preparedness and Response said that it was struck by how WHO was “underpowered to do the job expected of it”, and that “inequalities both within and between nations have worsened” as marginalised communities are locked out of healthcare.
WHO Powers To Validate Disease Outbreaks Gravely Limited – Incentives For Countries’ Cooperation ‘Too Weak’ – Says Independent Panel

“The Panel is struck that the power of WHO to validate reports of disease outbreaks for their pandemic potential and to be able to deploy support and containment resources to local areas is gravely limited,” the panel, which is chaired by ‘two former prime ministers, Liberia’s Ellen Johnson Sirleaf and New Zealand’s Helen Clark, reported.

“The incentives for cooperation are too weak to ensure the effective engagement of states with the international system in a disciplined, transparent, accountable and timely manner,” it added.

The report by the panel of 11 international experts also observed that “inequalities both within and between nations have worsened as vulnerable and marginalized people in a number of countries have been left without access to health care, not only to treat COVID-19 infection, but also because health systems have been overwhelmed, shutting many out of basic care and services”.

To address this, it stated that “fundamental and systemic change in preparedness” is necessary to introduce a new global framework “to support the prevention of and protection from pandemics”.

But this will need the global community to “come together with a shared sense of purpose and to leave no actor outside the circle of commitment to transformative change”, it acknowledged.

Trends in vaccine access by the Independent Panel for Pandemic Preparedness & Response (The Independent Panel) to the 148 Executive Board.

As of 17 January, 50 countries have started administering vaccines. 40 of these were high-income countries, and 95% of the estimated 40 million vaccine doses that have been dispensed so far were done so in only 10 countries.

Numerous member states including Australia, Bangladesh, China and New Zealand expressed their concern about the inequitable access to the vaccine.

Representing the African region, Botswana called for “global solidarity to prioritize investment in affordable and safe COVID-19 vaccines and equitable allocation, based on the principle of fairness”.

Lemogang Kwape, Botswana Minister of International Affairs and Cooperation, described the “great inequality in COVID-19 vaccine availability” as a public health concern. It said that Africa’s response to the pandemic had already been affected shortages in personal protective equipment, ventilators and other essential medical items.

Brazil, currently facing rising COVID-19 infections and deaths as part of its second wave, called for action to ensure equitable access of COVID-19 products and technologies.

“At this critical juncture, this Executive Board should make a strong call for members, WHO, other international entities, and pharmaceutical companies to deliver in full and as a matter of urgency on their pledges and commitments to the fair and equitable distribution of COVID vaccines everywhere,” said Ambassador Maria Nazareth Farani Azevêdo, Permanent Representative of Brazil to the UN Office in Geneva.

Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, warned that “case and cluster investigations, contact tracing and support the quarantine of context remain underpowered in almost every country” and “we haven’t expanded the use of rapid diagnostic tests as much as we would like”.

China Appeals for Origin Research Not to Be Politicized

Meanwhile, China appealed for research into the origin of the virus not to be politicized, stressing that the country had “always been open, transparent and responsible”.

After months of delay, A WHO-led investigative team arrived on 14 January in Wuhan to begin what is supposed to be an independent query into the origins of the virus, which first emerged among clusters of people working around a wildlife market in Wuhan.

Leading up to the team’s arrival, however, China has launched an extensive media campaign to try to shift the narrative about the origins of the virus elsewhere – suggesting most recently that it could have come from Southeast Asia. This is despite pre-pandemic research indicating that the SARS-CoV-2 family of viruses pre-pandemic circulates in bats in the Hunan region of south-central China – an area to which Beijing has recently barred access.

The WHO team investigating the origins of the COVID-19 pandemic arrived in Wuhan on Thursday. The US representative to the board said the team’s investigation would only be successful if it had access to a wide range of information “currently in the possession of Chinese authorities”.

In light of China’s clear interest in shaping the virus origins narrative, leading European, American and western Pacific governments have expressed concern about whether the investigative team could really do its work. Last week, WHO’s Dr Ryan clarified that the investigation is not a matter of assigning blame, but “is about finding the scientific answers”.

Even so, Garrett Grigsby, Director of the Office of Global Affairs in the Department of Health and Human Services, said today the WHO expert team currently in China to investigate the origin of the virus would only be successful if it had access to a wide range of information “currently in the possession of Chinese authorities”. This includes animal tests from in and around Wuhan, environmental samples from the markets, comparative analysis of animal and human genetic data and samples.

This message was echoed by the representatives from Japan, Canada, Australia, and Austria, on behalf of the EU.

“We wish to reiterate the importance of the international expert team to be able to access all the necessary studies and information to achieve a scientific, objective and transparent investigation,” said the EB representative for Japan.

“We welcome that the international expert team was finally allowed to travel to China to start their investigation in cooperation with Chinese counterparts. We hold great importance to this investigation, which requires transparency, access to locations and data, and full cooperation. We request to be regularly briefed on the progress,” said Ambassador Elisabeth Tichy-Fisslberger, Permanent Representative of Austria to the UN Office in Geneva.

Image Credits: Independent Panel on Pandemic Preparedness, Johnson & Johnson, CGTN.

WHO has said there is no need yet for countries to install a “vaccine passport” system for travellers. Meanwhile, a number of countries like the UK have blocked travel from Brazil following the identification of a new variant in the country.

Many areas of Brazil, particularly Manaus, are experiencing worsening COVID-19 outbreaks and extremely high levels of infections, amidst news of a new variant that is spreading in the country.

Brazil joins countries around the world – including those in Europe, the Americas, and some parts of Africa – that are seeing spikes in cases and the spread of numerous SARS-CoV2 variants – as the world surpassed two million deaths from COVID-19, reported World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus at a press conference on Friday.

“This is because we’re collectively not succeeding at breaking the chains of transmission at the community level or within households. We need to close the gap between intent and implementation at the country and individual level,” Dr Tedros said.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday.

At the press conference, the WHO officials attempted to assuage concerns over the variants, instead highlighting the greater role played by increased social mixing, a breakdown in compliance with public health measures, and health systems already been weakened by previous infection waves.

“A small proportion of [the rise in infections globally] may be due to the emergence of variants that are fitter, but the large proportion of that transmission has occurred because we are reducing our social physical distancing,” said Michael Ryan, Executive Director of WHO’s Health Emergencies Programme. “The virus is exploiting our lack of tactical commitment, our fatigue, the breaking down of our behaviour.

“It’s too easy to just lay the blame on the variant and say it’s the virus that did it. Unfortunately it’s also what we did. And we have to be able to accept our share [of responsibility] as individually and as communities,” said Ryan.

The variant identified in Brazil, with similarities to the highly infectious variants detected in Britain and South Africa, has led to the UK’s decision to ban the travel of individuals from several Latin American countries and Portugal, with other countries potentially following suit.

Areas in Brazil with high caseloads are suspected to have “the worrisome B.1.1.28/P1 lineage. It has [several] mutations in the all-important spike; and moreover mutations in the spike’s critical binding domains,” said Eric Feigl-Ding, Senior Fellow at the Federation of American Scientists, on Twitter. “And most of all the worrisome E484K mutation that can evade antibodies.”

Although several experts have raised the alarm about this particular variant due to its inclusion of the key mutations of interest – E484K and N501Y – Ryan claimed that attributing the blame for increased transmission fully on the variant is unreasonable.

Mike Ryan, Executive Director of WHO Health Emergencies Programme.

The WHO has recorded the deterioration of conditions in Brazil, especially in Manaus, the capital of the state of Amazonas, where hospitals are running out of PPE, beds, and oxygen. 

Over 4,000 new COVID-19 cases and 50 confirmed deaths have been reported per day in Manaus. The ICU has been operating at 100% capacity for the past two weeks, with 2,000 people hospitalized and 400 people with COVID-19 waiting to be hospitalized. 

“This is a health system under extreme pressure,” said Ryan. 

“If this continues, we’re going to see a wave that was greater than what was a catastrophic wave in April and May in Amazonas and particularly in Manaus, which is a tragedy in itself,” he added. 

“This is an unprecedented calamity,” said Jesem Orellana, a local epidemiologist, in an interview with the Guardian. “In the coming hours, Manaus is going to be the protagonist of one of the saddest chapters of the COVID-19 epidemic in the world.”

The situation in Brazil is also due in part to widespread breakdowns in the health system. Mariângela Simão, WHO’s Assistant Director General of Access to Medicines and Health Products.  She called on countries to learn from Brazil.

“Don’t let a false sense of security bring your guard down. If you have built up infrastructure for ICU beds and oxygen distribution points…don’t shut it down because it’s not over yet. I think we need to learn from what’s happening – the terrible situation that Manaus is facing right now,” she said. 

WHO Setting Up Monitoring Framework To Evaluate SARS-CoV2 Variants of Concern

Meanwhile, WHO is setting up a monitoring framework to evaluate the mutations of interest and the variants of concern to better understand what the mutations and variants mean and how they impact the behaviour of the virus.

“We are in a race between the virus, which is going to continue trying to mutate in order to spread more easily, and humanity, which is trying to stop this spreading,” said Didier Houssin, chair of the WHO International Health Regulations Emergency Committee. 

The virus will continue to mutate and variants will continue to be reported, warned Maria Van Kerkhove, WHO COVID-19 technical lead.

“There is pressure on this virus to change [and] the more it circulates, the more opportunities it has to change,” she said. 

This message has been highlighted by other experts. “The fact that we’ve observed 3 variants of concern emerge since September suggests that there are likely more to come,” warned Trevor Bedford, Associate Professor in Fred Hutch’s vaccine and infectious disease division. 

In addition, the simultaneous and independent evolution of the virus resulting in several common mutations is potentially a dangerous sign, as “converging evolution…[typically] means nature discovered repeatedly it works,” said Feigl-Ding. 

As the virus evolves and becomes better adapted to infecting humans, individuals, communities, and countries need to become more efficient at fighting the virus, stressed members of the press conference.

“We still have tools that can break the chains of transmission. The interventions that have been outlined by WHO…work at breaking chains of transmission. Variants and the detection…and the emergence of variants makes it harder, but we still have some control over this virus,” said Van Kerkhove.

Maria Van Kerkhove, WHO COVID-19 Technical Lead, at the press briefing on Friday.

A study published by the US Centers for Disease Control and Prevention (CDC) on Friday – projecting that a SARS-CoV2 variant will become the dominant source of infection in the United States by March – echoed Van Kerkhove’s message.

“Collectively, enhanced genomic surveillance combined with continued compliance with effective public health measures, including vaccination, physical distancing, use of masks, hand hygiene, and isolation and quarantine, will be essential to limiting the spread of SARS-CoV-2” and lessening the potential impact of the B.1.1.7 variant, said the authors of the study.

Travelers Should Not Have To Provide a ‘Vaccine Passport’ At This Stage – WHO Emergency Committee Recommends

In terms of travel policies, international travellers should not be required to provide proof of COVID-19 vaccinations for international travel at this stage because there are still “critical unknowns” about whether the vaccine can reduce transmission – and because vaccines are not widely available, WHO’s Emergency Committee recommended this week.

However, this does not mean that requiring proof of vaccination from travellers “won’t be a good idea in the future,” said Ryan.

“But at the moment, we are lacking critical evidence regarding whether or not persons who are vaccinated could continue to be infected, or continue to transmit disease, and because nobody in the world beyond health workers and very vulnerable people have access to the vaccine,” said Ryan.

“The scientific evidence is not complete and there isn’t enough vaccine and therefore, we shouldn’t create an unnecessary restriction to travel until such time as we have the evidence and the vaccine is available.” .

At the time, more coherent guidance about how people can safely travel “by air, by road [and] by sea” is needed, acknowledged Emergency Committee chairperson Didier Houssin, in reporting about the Committee’s meeting on Thursday.

Didier Houssin, Chair of the WHO Emergency Committee.

“One of the recommendations of the committee is that WHO takes a strong lead in order to produce a very clear guidance and scientifically-based guidance about how best to facilitate and permit the circulation of people in a safe manner,” said Houssin.

Australian airline Qantas has announced that all international passengers will need to provide proof that they have had a COVID-19 vaccine in order to board its planes.

‘Have Hope’ That Vaccines are On the Way

Meanwhile, Soumya Swaminathan, WHO’s Chief Scientist, appealed to those living in countries that have not yet gained access to vaccines to “have hope” that supplies will soon become available through the WHO-supported COVAX vaccine platform, which over 180 countries have joined.

“We do have a guarantee of at least 2 billion doses at the moment [through COVAX], but perhaps a lot more than that by the end of 2021,” she added.

Soumya Swaminathan, WHO Chief Scientist.

The first vaccine doses to be acquired through the COVAX Facility – co-led by WHO, the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance – will be distributed between 92 of the countries that have signed up at very low or no cost.

“We anticipate that the first tranches of vaccines will start going out in the first quarter of this year, even though they may be in small volume. We also need to recognise that vaccines do need to go through the stages of testing and need to complete trials and have data on efficacy and safety, and they need to be manufactured in a quality assurance facility,” said Swaminathan.

COVAX’s procurement plans include pre-orders of just one vaccine, by AstraZeneca and Oxford University, which has received regulatory approval in the USA and Europe.  But others to which it has committed (Johnson & Johnson and GSK/Sanofi) have not yet submitted the results of Phase 3 trials to either WHO or a national regulatory agency for approval.

“In an ideal world, we would not have the unequal access to the COVID-19 vaccine that we are currently seeing,” Simão conceded.

WHO Director-General Dr Tedros Adhanom Ghebreyesus made an appeal for solidarity from wealthier countries, reminding them that when “AIDS drugs were first rolled out, they were only available in right in rich countries until a historic movement of health advocates and civil society led to the rollout of low-cost, generic versions of antiretroviral drugs.

“We don’t want this to be repeated.”

Image Credits: Wikimedia Commons: Nemo, WHO.

A recent poll indicated that less than a third of Filipinos are willing to be vaccinated, sparking concerns that a less efficacious vaccine would do little to change minds.

The Philippines is expecting to receive its first batch of China’s Sinovac Biotech COVID-19 vaccine next month — but one leading Filipino senator is questioning the government’s preference for the candidate as new data indicates a lower efficacy rate than western competitors.

Earlier this week, developer Sinovac Biotech reported an efficacy rate of only 50.38% in its final stage trials, undertaken in Brazil. The company has claimed, however, that this low rate is due the fact the vaccine was trialled on medical workers, who have a naturally higher risk of catching coronavirus.

Western vaccines like Pfizer/BioNtech’s or Moderna’s were trialled mostly among members of the public, and earned efficacy rates of 95% and 94.5% respectively.

The main concern expressed by the Filipino senators appears to be founded in the public’s limited confidence in vaccines; a poll last week by Pulse Asia indicated that less than a third of Filipinos are willing to be vaccinated.

“The insistence or preference for Sinovac cannot be denied and will not augur well for building up confidence of people in our ability to address the pandemic,” said Senate Minority Leader Franklin Drilon, addressing the country’s COVID task force on Friday.  Drilon is the leader of the opposition parties in the Senate.

The country has one of the highest  number of coronavirus cases in Asia, but its vaccination programme is lacking on the continent.

As of 13 January, China had vaccinated around 10 million people. The Philippines had not approved a single vaccine, but the government hopes to vaccinate 70 million people this year.

Drilon questioned: “There are other vaccines with a much higher efficacy at lower, if not more competitive, cost. Why are we insisting that we buy Sinovac?”

The Sinovac vaccine has not yet been granted emergency use authorization, with the Philippine Food and Drug Administration (FDA) only receiving the request on Wednesday. The FDA approved Pfizer the following day: the country’s first vaccine.

President Rodrigo Duterte had previously said that he would prefer to have his country’s COVID vaccines sourced from China or Russia, which some observers have interpreted as as part of the president’s pursuit of closer relations with Beijing.

Image Credits: Bret Bostock/Flickr.

The Berlaymont Building in Brussels, which houses the European Commission

Deliveries of the Pfizer/BioNTech vaccine to all European Union (EU) states will be reduced for an undisclosed period starting from next week, Norway’s National Institute of Public Health has said.

The sudden change to delivery schedules, Pfizer announced on Friday, is due to a reorganization of the company’s production capacity. It did not say how long this would take.

The  pharmaceutical company also said that after the reorganization it will be able to increase production from 1.3 billion doses a year to 2 billion.

Total number of single vaccination doses administered, since 19 December 2020 as of 15 January 2021.

So far, the EU has secured a total of 300 million doses of the Pfizer candidate, to be distributed across its 27 member states by the end of 2021. On 8 January, the European Commission proposed purchasing an additional 200 million doses, with the option to acquire an additional 100 million beyond that. The vaccine was approved for use in the EU in late December.

It is not clear by how much deliveries to the EU will be reduced, or how this will be reflected in doses received by individual member states.

Norway’s National Institute of Public Health confirmed, however, that the 43,875 doses it expected to receive in the third week of its rollout has been lowered to 36,075: a decrease of 17%.

The public health body confirmed that it will cover the reduction with its emergency stock that it had “kept in readiness for such cases”.

Biden Advisor Predicts Rocky Start To Vaccine Plan

Incoming US President Joe Biden had promised to administer an ambitious 100 million vaccines in the first 100 days of his presidency.

But Michael Osterholm, of Biden’s COVID-19 task force, has clarified that the earlier days of that time frame will see less doses injected than the later days.

“The first days of that 100 days may be substantially slower than it will be towards the end,” he said, adding that “it’s not going to occur quickly.

“You’re going to see the ramp-up occurring only when the resources really begin to flow.”

Currently, the Trump administration has vaccinated just more than 10 million citizens in around 30 days. Biden’s pledge to administer 100 million in 100 days — which likely will not be broken down as 1 million per day, based on Osterholm’s comment — would represent a massive step up in the country’s immunization campaign.

The anticipated slow start to Biden’s vaccine plan is largely down to availability of resources, it seems. As Nicole Lurie, a pandemic advisor to Biden, said prior to the election, ramping up vaccinations after the Trump presidency would not be achieved with the “flip [of] a switch”.

The goal, Osterholm said, is “aspirational” but, importantly, “doable”.

Image Credits: almathias, Our World in Data.

COVID-19 immunity from previous infection does not guarantee people still won't carry and transmit the virus
COVID-19 immunity from previous infection does not guarantee people still won’t carry and transmit the virus

Past COVID-19 infection may provide immunity for several months, but still leaves risk of transmission to others, a Public Health England (PHE) study has found.  

“This means even if you believe you already had the disease and are protected, you can be reassured it is highly unlikely you will develop severe infections but there is still a risk that you could acquire an infection and transmit to others,”  said Professor Susan Hopkins, Senior Medical Advisor at PHE and study lead at SARS-CoV-2 Immunity and Infection EvaluatioN (SIREN). 

Since June, the PHE’s SIREN study has performed regular antibody and PCR testing on 20,787 healthcare workers, including frontline clinical staff and those in non-clinical roles. 6,614 of these participants tested positive for COVID-19 antibodies upon recruitment. 

Between 18 June to 24 November, there were 44 potential reinfections identified by the study, with 2 designated ‘probable’ and 42 ‘possible’ based on available evidence. If all 44 cases were confirmed, this would represent an 83% rate of protection from reinfection, though if only the 2 ‘probable’ reinfections were confirmed, the rate would be 99%. Further research is ongoing to clarify this range. 

The study found that antibody protection after infection lasts for at least 5 months, on average. Scientists are studying whether this protection may last for longer, but this means that many people who contracted the disease in the first wave of the pandemic may now be vulnerable to reinfection. 

Although those with antibodies have some temporary protection against COVID-19, some of these individuals carry high levels of the virus and could continue to transmit the virus to others. 

More Research Needed to Understand Effectiveness of Vaccines in Reducing Transmission

In December, the UK identified a vriation of SARS-CoV-2 now known as VOC 202012/01 (Variant of Concern), but formerly referred to as VUI 202012/01 (Variant Under Investigation).

Further work is underway to understand whether and to what extent antibodies also provide protection from this variant. The study will continue to follow participants for 12 months to explore how long any immunity may last and to what extent people with immunity are able to carry and transmit the virus. 

Peer reviewed Phase 3 clinical trial results for Moderna vaccine, published 30 December 2020 in the New England Journal of Medicine, have suggested that vaccination also reduced asymptomatic transmission by about two-thirds, in the case of Moderna’s mRNA-1273 vaccine, though the numbers examined were small. The duration of immunity and the amount of the virus reduced in those vaccinated still needs to be researched. 

SIREN data from the first report does not provide evidence towards antibody or immune responses from COVID-19 vaccines. Vaccine effectiveness will also be studied later this year by the PHE SIREN study. 

With cases at their highest level to date in the United Kingdom, the PHE advocates that everyone does their part to avoid the risk of transmitting to other people. 

Said Hopkins: “This study has given us the clearest picture to date of the nature of antibody protection against COVID-19 but it is critical people do not misunderstand these early findings.” 

“Now more than ever it is vital we all stay at home to protect our health service and save lives.”

Image Credits: Yuri Samilov/Flickr.

A doctor preparing to administer a Sinopharm COVID-19 vaccine in China.

After months of delay, a pared-down WHO research team charged with investigating the origins of the SARS-CoV2 virus finally arrived in China on Thursday – but two members of the team were left behind in Singapore after they tested positive for COVID-19 antibodies, WHO said.

In the 24 hours since, one of these two members – a British scientist – has now been permitted to enter after reportedly testing negative on subsequent tests. The remaining team member – a scientist from Qatar – still tested positive, China’s Foreign Ministry confirmed.

The remaining WHO team members flew directly to Wuhan, where the first clusters of SARS-CoV2 virus cases in humans first emerged just over a year ago, and were set to begin work with their Chinese colleagues remotely while they waited out a 14-day quarantine.

A brief update on their activities was provided at the WHO press briefing on Friday, however, officials emphasized the independence the team will need to conduct their investigation. “What we need to do is let them do the work and carry that out and put the information that all of them are learning together into context,” said Maria Van Kerkhove, WHO COVID-19 Technical Lead. “Let’s let them follow the science and we’ll report when we can.”

The team of scientists are “a wonderful group of people, and we trust that with the cooperation and the hospitality of the Chinese government and Chinese people and the authorities in Hubei and Wuhan, we will have a successful mission,” said Mike Ryan, WHO’s Executive Director of WHO’s Health Emergencies Programme, on Friday.

The arrival of the team coincided with a domestic surge in COVID-19 cases in China, where some 22 million people were placed under lockdown after the nation recorded its highest one-day incidence of new COVID-19 cases since July. Outbreaks were concentrated in three cities of Hebei Province – a northern Chinse province near Beijing that was the site of the imperial summer residences of Qing-dynasty leaders. 

The WHO team investigating the origins of the COVID-19 pandemic arriving at the Wuhan Tianhe International Airport on Thursday.

According to the WHO, the two members of team remaining in Singapore had tested positive on IgM antibody tests, which indicates that they may have a recent infection – even though other tests had been negative. The team members will undergo further testing, and WHO said it would provide an update on their status.

During the Wuhan quarantine period, the team will work remotely with counterparts at the China CDC, health ministry, and research centers, whom they will also meet in person after two weeks. The experts will then visit sites and conduct research for the investigation. 

“The idea is to advance a number of studies that were already designed and decided upon months ago to get a better understanding of what happened last year in December,” said Peter Ben Embarak, expert on food safety and zoonosis at WHO and WHO coordinator of the expert team, in a WHO interview released on Wednesday. “[We] will be looking in more detail at the initial cases [and]…the famous market…trying to find out everything that went in and out of that market in the weeks ahead of the event.”

Many, but not all, of the first cases were concentrated around the Wuhan Seafood Market, where wild animals were typically kept alive in pens, before being slaughtered for shoppers, in conditions that allowed viruses to fester and potentially infect humans.  Even so, not all of the first SARS-CoV2 cases have been traced to the market.

“It could be a very long journey before we get a full understanding of what happened,” he added. “I don’t think we will have clear answers after this initial mission, but we will be on the way and hopefully in the coming months, that will be completed by additional missions and additional studies.”

In contrast to its actions two weeks ago, When China barred the mission’s entry at the last minute over alleged VISA issues, China’s National Health Commission said that the country was willing to cooperate with the investigation. 

But it highlighted what it said was a need for the hunt for the virus origins to be on a worldwide scale.  

“Origin-tracing of the novel coronavirus is a scientific matter, and should be conducted in cooperation [with] scientists across the world,” said Zhao Lijian, a Foreign Ministry spokesperson, in a press release. “With constantly intensified knowledge about the virus, and the discovery of more early cases, it is highly likely that origin-tracing will involve many places across the world, and the WHO will conduct similar inspections in other countries if needed.”

Over the past few months, China’s state-controlled news channels have begun to construct an alternative narrative, claiming that the human infections with SARS-CoV2 may not have first originated in China at all – even though China is the place where the most genetically comparable strains of coronaviruses have been reported to be circulating in the wild, in bat populations in Hunnan province.   Foreign journalists and researchers have been recently barred, however, from accessing those remote rural sites.

There have meanwhile been months of delay, first in forming the 10-member team of international experts that was mandated by the World Health Assembly in May to conduct the investigation, followed by more delays in getting China’s agreement to permit the visit.

Surge of Cases in China 

Most of the new cases were reported in the cities of Shijiazhuang, Xingtai and Langfang – located in the province neighbouring Beijing. The outbreak is suspected to have arisen from a series of weddings and funerals. 

The National Health Commission of the People’s Republic of China reported its first COVID-19 death in eight months on Wednesday in Hebei province. According to state health agencies, no deaths have been reported on mainland China since May, however, the WHO has recorded 12 deaths so far in 2021 in the nation – a discrepancy that has not been explained by Chinese health officials.

Authorities have implemented stringent restrictions and have stepped up screening and prevention measures. Bans on gatherings, outbound travel, school meetings, and the provincial Communist Party conference have been established and millions are under stay-at-home orders. 

Efforts to tackle the outbreaks have been swift, particularly as fears of the development of more clusters mount ahead of the week-long Lunar New Year holiday next month. Over 3,000 medical workers were mobilised to assist with a mass testing programme, which has tested more than 10 million people since early last week. 

A citywide testing programme in Langfang was begun on Tuesday, which plans to test 5 million people in three days, while residents in Shijiazhuang and Xingtai will go through a second round of mass testing, the National Health Commission announced on Wednesday. 

Concern about the outbreak is especially high, given its proximity to Beijing and the upcoming annual meetings of the national legislature and advisory conference. The Chinese Center for Disease Control and Prevention (CDC) published a press release last week, emphasising the need to “resolutely safeguard the safety of the capital,” trace the origins of the outbreak, and strictly control movement in the city. 

“Due to the special security needs of the capital and the flow of people and freight between Beijing and Hebei, [we must] heighten our sense of responsibility to reduce the risks of importing cases,” said the government of Tongzhou, a district in Beijing bordering two Hebei cities. 

China plans to continue with its goal of inoculating 50 million people prior to the Lunar New Year, when hundreds of millions are expected to travel. Over 9 million doses of the Sinopharm COVID-19 vaccine have been administered nationwide as of Monday, with the prioritisation of health care workers, workers handling imported cold-chain food, and high risk individuals.

Officials have reassured the public that the outbreaks are under control, while also advising individuals to avoid public gatherings and travel ahead of and during the holiday.

“I’m deeply confident that the epidemic spread in Shijiazhuang will be controlled within a month,” Zhang Wenhong, leader of the Shanghai team of experts responsible for the clinical management of COVID-19 cases, said in a press release. “Individuals should stay alert to the pandemic but there’s no need to be excessively nervous.” 

Image Credits: CGTN, 中国新闻网.

DELHI, INDIA – In the last week of December 2020, Chanda Devi heard a truck roll into her neighborhood in North Bhopal, Central India.

Residents were called outside by a voice, booming through loudspeakers. They were eligible to collect Rs 750 (about US$10) to receive a “corona vaccine”. The people said that they were recruiters, representing the People’s Hospital, Bhopal.

“They told us that we can get the Corona vaccine now,” Devi, 60, said. “Later we may have to pay for it. They told us that if we take the vaccine we won’t get corona disease.”

Devi, 60, sells costume jewellery house-to-house for a living, making about US$2-6 a day. She also lives in one of the areas worst affected by the 1984 Bhopal gas tragedy – widely regarded as the worst industrial disaster of modern times – whose impacts echoed around a globalizing world.

The disaster took place on 3 December 1984, when about 45 tonnes of methyl isocyanate, an input in the manufacture of pesticides, leaked from the American-owned Union Carbide Corporation plant, exposing 500,000 of the city’s residents to the highly toxic gas. The leak killed nearly 4,000 people immediately and upwards of 20,000 people in subsequent years.

Many of those who survived, like Devi who was 24 at the time, have continued to live in slums just behind the now-abandoned plant. Some have suffered from long-term disabilities, such as blindness and respiratory complications. Compounding those problems, the community was also exposed for decades to groundwater contamination from years of toxic waste dumping on the site.

It was against this difficult background that Devi presented herself at the People’s Hospital, Bhopal, on December 19 2020, to take part in the randomised double-blinded Phase 3 trials for India’s leading domestically-created vaccine candidate, Covaxin, developed by the pharma company Bharat Biotech together with India’s National Institute of Virology.

Devi, who is also illiterate, did not understand, however, that she was being recruited as a clinical trial participant. She was under the impression she was going to receive an already approved COVID-19 vaccine.

Participant Death Adds To Questions About Clinical Trial Recruitment Process

An estimated 700-800 vulnerable victims of the Bhopal gas tragedy have been recruited for the Covaxin trial since early December, allege community activists, like Rachna Dhingra, who work with gas leak victims.

Questions were amplified when, in the last week of December, one trial participant – Deepak Marawi, a 45-year old daily wage labourer – died after receiving the first dose of Covaxin. The deceased Mawari was a participant at a trial site of People’s Hospital, Bhopal. He got his first dose on 12 December and died on 21 December.

A postmortem has since suggested the death was unrelated to the clinical trial, but it has sparked alarm regardless.

In a statement, Bharat Biotech said that “the probable cause of death was due to cardio respiratory failure as a result of suspected poisoning”.

It added: “The volunteer passed away nine days after the dosing and preliminary reviews by the site indicate that the death is unrelated to the study dosing. We cannot confirm if the volunteer received the study vaccine or a placebo as the study is blinded.”

His family alleged that he was not followed up regularly after he received the dose.

Ethical Questions Emerge Over Recruitment of Bhopal Community Members ‘Whose Health is Compromised’

Even so, the circumstances around Mawari’s death have raised broader ethical questions about Covaxin’s clinical trial process.

Concerns are even greater since the Indian Health Ministry recently approved the Covaxin vaccine for restricted emergency use despite the fact that Phase 3 trials are not even concluded – in a process that was obscure and under terms that are still unclear.

Following that approval, Covaxin is due to be administered to members of the broader public beginning 16 January, at the launch of India’s vaccination programme. Alongside Covaxin, the AstraZeneca vaccine, already approved by British regulators, is also due to begin rollout at the same time.

On Sunday 10 January 2021, Devi and three other trial participants spoke about their clinical trial recruitment experiences during a virtual conference, organised with the support of a network of nonprofits that work with victims of the 1984 gas leak – and in which Health Policy Watch participated.

The four participants said they were led to believe they were receiving the vaccine as a part of the government’s vaccination drive, and were not clearly told that they were taking part in a clinical trial. They were not provided with any informed consent forms to review and sign, alone or with a literate family member. Nor was their consent video-recorded, in the case of people like Devi who are illiterate. In other  words, they said that they did not provide their informed consent.

Despite being illiterate, Devi and other participants in the video conference said that they received sheaves of papers to record any symptoms they experience after they receive their dose – even though they would not know how to fill them out.

On the same day that Marawi died, a group of NGOs wrote to both the Indian Prime Minister and Indian Health Minister, Narendra Modi and Dr Harsh Vardhan, to stop the trial and conduct a detailed inquiry into the incidents.

“Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India,” the letter stated.

“This is leading to exploitation and harm to a community of people that are not just economically and socially deprived but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences.”

In response, Bharat Biotech in a statement that the trials were conducted “in compliance with the study protocol, Good Clinical Practices (GCP) Guidelines as well as with all applicable statutory provisions and the focus at all times is on patient safety. It is this intent on compliance, quality and ethics, that we have enlisted the services of an international contract research organization to conduct our phase III clinical trials”.

Trial Participants Include At Least 700-800 People From the Bhopal Communities Affected By the Gas Leak

At least 700-800 people were recruited from the communities in the areas affected by the gas leak, and related groundwater contamination, said Rachna Dhingra, an activist who works with victims of the Bhopal gas tragedy, at the briefing.

“Almost all these communities drank contaminated ground water,” she notes. “There are persistent organic pollutants in the water. People here suffer from a range of health problems. Instead of paying attention to their problems, they have been used,” she said.

“Most of the people living in this area have one phone between five people,” Dhingra said, speaking at the video conference. “The phone is only with the head of the family who is often out of the house during day time. If someone (from the hospital) has to follow up [with a participant] in these areas, they have to go to their homes.”

Some Trial Participants Say They Fell Ill – But Had No Recourse

Some of the trial participants who fell sick after being administered either the vaccine or a placebo, said that they had to seek treatment on their own, with their limited income. The day wage earners became stuck at home, unable to work.

Twenty-six year-old Chotu Das Bairagi said that he was diagnosed with COVID-19 only a few days after receiving the first vaccine dose.

“When I went to get treatment, they just prescribed some medicines. I was asked to buy them myself,” said Bairagi. Only after he posted a video about his illness, the hospital called him back and provided some treatment.

“They did not know that it is their right to receive free treatment when they participate in a trial. Some of them are scared of going back to the hospital,” said Dhingra.

While other participants said that they were told they were participating in a “trial”, they said that they did not really understand the meaning of the English word. And additionally, the Hindi poster published to recruit participants said that participating would be “beneficial”.

“Why do you need to conduct a clinical trial if they know that the product is beneficial. Why were consent forms not given to them?” said Anant Bhan, a researcher in bioethics and global health in the video conference.

“These are vulnerable populations. There are special provisions under the  New Drugs and Clinical Trial Rules, 2019 and national ethical guidelines for clinical trials which say that the informed consent needs to be audio-visually recorded.”

Dr Anil Dixit, the dean of the hospital conducting the trial said that the trial site had followed all the norms and said in a video statement: “The signed consent forms can be given to the participants if they wish. They are kept in the hospital usually.”

Critics Attacked For ‘Sullying Name’ of India’s R&D

Dhingra said that the stories about the participation of Bhopal gas victims in the Covaxin trial shed concerns on broader issues associated with the clinical trial process.

“These people are saying that the adverse events they suffered were not recorded properly. They were not followed up regularly. Their data is not being recorded. How do we know about the efficacy of the vaccine?” she asked.

In a tweeted response, People’s Hospital’s called the attempts to sully the trial “pathetic” and said that instead of applauding the Indian’ government’s endeavour in developing vaccines, some people are making “spurious comments to be in public attention.”

So far Ministry of Health regulators have not addressed the allegations around the Covaxin clinical trial processes in Bhopal. Nor has Bharat Biotech made any statement – beyond the one referring to the death of Marawi.

That silence has added to the concerns around the transparency and safety of clinical trial processes – and with that, of the vaccine that is due to be rolled out at a much larger scale in just two days time.

“By ignoring the ongoing criminal irregularities in the Covaxin trial in Bhopal, the Government is potentially unleashing a public health disaster on the 16th of this month”, said Nousheen Khan of the Children Against Dow Carbide.

The Africa Union has secured an additional 270 million COVID-19 vaccine doses outside of WHO’s COVAX platform. At least 60% of the continent’s 1.2 billion population must be vaccinated to achieve population immunity.

IBADAN, NIGERIA – So far the continent has been obliged to look on as developed countries vaccinate millions of their citizens against SARS-CoV-2, but now African countries may also soon gain access to COVID-19 vaccines.

In a striking show of political unity, the African Union (AU) has secured provisional commitments to procure some 270 million COVID-19 vaccine doses for its 55 member states, and 50 million of those doses will be available before April 2021.

Notably, the move was taken independently and outside of channels of international donor assistance. The doses which were secured by the African Vaccine Acquisition Task Team (AVATT), will be supplied by Pfizer, AstraZeneca (through an independent licensee, the Serum Institute of India) and Johnson & Johnson, whose vaccine is set to go before the United States Food and Drug Administration for approval later this month.

AU Chair and the President of South Africa, Cyril Ramaphosa, disclosed in a statement that the secured doses are in addition to those the continent has been guaranteed through the WHO co-sponsored COVAX Facility.

Dr Matshidiso Moeti, WHO Regional Director for Africa.

COVAX — an initiative aiming to deliver vaccines to low- and middle-income countries, and co-led by Gavi, the Vaccine Alliance — has secured an estimated 600 million doses for the continent.

The need to access vaccines outside of the COVAX framework has become apparent insofar as the limited supplies available would leave many Africans unprotected if the continent were to rely on the Facility alone, said Dr John Nkengasong, Director of the Africa Centers for Disease Control (Africa CDC).  COVAX aims to procure and supply vaccines for about 20% of the population in countries that have joined the facility in 2021. 

“COVAX has said [it] will supply the continent with about 20% of our needs,” Nkengasong said during a press conference.

“And our vaccine strategic plan states that we need to vaccinate at least 60% of the population of the continent of 1.2 billion to achieve population immunity.”

“From the onset of this pandemic, our focus as a continent has been on collaboration and collective effort,” Ramaphosa said. “We have held steadfastly to the principle that no country should be left behind.

“With this in mind, we have not only campaigned vigorously for changes through all the available international forums, but we have taken the additional step to independently secure vaccines using our own limited resources as member states.”

John Nkengasong, Director of the Africa CDC.
WHO Not Opposed To Procurement Outside COVAX Framework

Dr Matshidiso Moeti, WHO Regional Director for Africa told Health Policy Watch on Thursday that the Organization is not opposed to individual African countries securing their own doses outside of the COVAX arrangement.

Moeti’s remarks directly contradicted those of WHO Director General Dr Tedros Adhanom Ghebreyesus at a WHO press conference last Friday, when the DG admonished countries not to make more deals outside of the COVAX framework.  

Her more positive reaction to the AU moves, likely reflect both an increasing realism about the limits of what COVAX can supply – as well as the fact that the AU is acting on behalf of a large bloc of states that have often been the last in line for new health innovations. 

According to Moeti, WHO encourages countries to try every opportunity to mobilize the additional resources outside of COVAX, and to secure additional supplies. 

“The important thing is to reach a coverage of the population that will then stop the circulation of the virus,” Moeti said.

Warns Against Procuring Vaccines Lacking Regulatory Approval
Data as of 8 January, prior to the African Union announcement, which would more than double the available doses

But she also warned Africa’s WHO member states to refrain from ordering vaccines that have not been adequately tested in clinical trials.

“These should be vaccines that have been looked at and data reviewed in terms of their efficacy and in terms of their safety.,” she told Health Policy Watch. 

“WHO is and will continue to license some vaccines for emergency use, as manufacturers share data” with the health body, she added.

In fact, two of the three vaccines on the AU shopping list,  Pfizer’s and AstraZeneca’s  have already been approved already by United States, British and/or European regulatory authorities. And the J&J vaccine’s Phase 3 results are due to be published in about two weeks time, with the USFDA submission following shortly thereafter, according to a statement by the company on Wednesday.  

While Moeti did not mention specific vaccines to avoid, or countries, by name, The Seychelles is reportedly rolling out the Sinopharm vaccine produced by China, that has not undergone an independent and transparent review. In a related development, Brazil just reported that China’s CoronaVac vaccine had shown an efficacy rate of just over 50 percent in trials conducted there – meaning it barely passes the mark for efficacy. That was after Brazil had already pre-ordered some 380 million doses.  

Some other African countries also are reportedly considering purchases of Russia’s Sputnik vaccine, produced by the Gamalaya research institute.  Phase 3 Clinical trial results on the Sputnik vaccine also have not yet been reported either in the peer-reviewed press, to WHO or to any national regulatory agency that undertakes a transparent review process.  

One recent report, published just before the AU announcement, noted that so far 21 African countries had ordered vaccines in bilateral deals, for a total 260 million doses. Some 35% of those orders involve AstraZeneca doses for 7 countries, 33% of the doses represent China’s Sinopharm vaccine orders by 4 African countries, and just 1% of total doses are being ordered from Russia, the report by Development Reimagined stated. 

“Overall, only 4 of the 21 have ordered enough to cover more than 20% of their population so far,” the report went on to say, noting this was not even considering “the other 34 African countries that have not made any orders as yet”.

Putting the orders from Africa into global perspective Development Reimagined said orders from Africa account for only 3.4% of the global doses that have been ordered to date.

Data as of 8 January, prior to the African Union announcement.
AU Setes Up Vaccine Financing Plans

With regards to accessing the bulk AU vaccine purchase, African countries across the continent can either use their own funds or obtain a five-year loan with the African Export-Import Bank (Afreximbank), to ensure African countries are not locked out of mass vaccination.

“Afreximbank will, upon receipt of firm orders from member states, provide advance procurement commitment guarantees of up to US$2 billion to the manufacturers on behalf of member states,” an AU statement read.

According to the terms of the loan, repayment will be required by installments and over a period of five years.

Additional funding arrangements have also been arranged by the AU and the World Bank so that AU member states will be able to access about US$5 billion either to buy more vaccines or pay for delivery of vaccines committed on their behalf by Afreximbank.

Vaccine Plans Come As Second Wave Hits Africa

Over the last four weeks, Africa CDC said the number of confirmed cases across the continent has increased by 8% but the outlook varies across the regions.

In East Africa, despite the threats posed to the pandemic by the holiday season, cases dropped by 13%: a development that Nkenkasong described as “a good sign of hope”.

But there was a 5% increase in Central Africa, 21% increase in West Africa and 31% increase in South Africa.

In Northern Africa, at least, Africa CDC said the pandemic recorded no changes suggesting some stability in the region.

Moeti noted the state of the pandemic suggests that there is a need to reinvigorate response at different levels, particularly at the individual and community levels.

“We need to be looking for cases and contacts. We need to be testing and getting the results as fast as possible,” she said.

“And we need to be more consistent about isolating and breaking the chain of infection from people who are infected so I do think we’ll go through a difficult month or so as we see the surge from the festive season.”

Image Credits: NIAID, Africa CDC, Development reimagined , Development Reimagined .