The cautionary tale of the COVAX Facility

Newsletter Edition #45 [The Weekly Primer]

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Hi,

It is officially springtime in Geneva, but the chill is never too far away.

Today’s newsletter is a heavy-duty curated edition that tries to capture how countries world over are coping (or not), with the dizzying speed of the natural progression of the pandemic mediated by policy responses that seem to be perpetually falling short given the sheer complexity we face.

In the section below on policy updates, I have tried to put together an “editorial”. Let me know what you think of it by giving me your feedback in this two-question survey which should take you 30 seconds.

Just a quick housekeeping update:

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Best,

Priti

Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva

I. POLICY UPDATES

The Geneva Health Files Editorial

  • The many challenges facing the COVAX Facility

    With every passing month, the unanticipated challenges facing the COVAX Facility mounts.

    Take the AstraZeneca vaccine, which has been reckoned as the backbone of the Facility. Rising hesitancy towards this vaccine in the EU and elsewhere because of rare incidents of blood clots, despite the safety of the vaccine vouched by regulators, is only one concern. Following production shortages in the EU that broke out earlier in the year, the barriers to access AZ doses continue - the latest being on account of Indian government’s decision to temporarily hold the export of the vaccine to quell the surge of COVID-19 infections in the country.

    A press release issued by Gavi and WHO, on March 25th, said:

    “Deliveries of COVID-19 vaccines produced by the Serum Institute of India (SII) to lower-income economies participating in the COVAX Facility will face delays during March and April as the Government of India battles a new wave of COVID-19 infections. COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April.

    According to the agreement between Gavi and the Serum Institute of India (SII), which included funding to support an increase in manufacturing capacity, SII is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca (AZ)-Oxford vaccine (known as COVISHIELD) to 64 lower-income economies participating in the Gavi COVAX AMC (including India), alongside its commitments to the Government of India.

    To date, COVAX has been supplied with 28 million COVISHIELD doses and was expecting an additional 40 million doses to be available in March, and up to 50 million doses in April.”

    Subsequently, Reuters reported that COVAX will likely receive full supply from Serum by May, citing UNICEF.

    A concomitant number of factors have come to worsen an already bad situation for the global access to vaccines. Much of the world is now living through the failure of the political leadership at the global level in not anticipating production glitches associated with production of new vaccines. The recalcitrant position of the industry that has not tried to forge path-breaking solutions to meet the sheer proportion of the access challenge facing the world is hard to understand.

    In the particular case of Serum Institute and the AstraZeneca vaccine, both the Indian government and Gavi have contributed to the delay now facing low-income countries waiting for vaccines from the COVAX Facility. Here’s why.

    The role of the Indian government in handling the pandemic is one issue, another is its overall lack of preparedness to broad base the pool of production of vaccines, among other shortcomings. (WHO has often been a cheerleader of India’s role during COVID-19, but has rarely, publicly called out some of the approaches taken by the government.) To be sure, India is not unique in the challenges it faces.

    At stake is not its reputation as a vaccine powerhouse, but also overseeing that contractual obligations of an Indian manufacturer are met. The legitimate need of addressing rising burden of the disease in India is unquestionable. However, in a pandemic, global demands also determine domestic policy-making. Without a deft handling of this, India’s supposed gains on vaccine diplomacy could run dry even before the pandemic runs its course. (As for SII, nearly no company in India can stomach a fight with the government, pandemic or no pandemic.)

    As Reuters had reported, “India has so far administered more than 54 million doses, of which 49 million are the SII’s locally-made version of the AstraZeneca vaccine. The rest is the COVAXIN vaccine developed in India by Bharat Biotech. The government has so far asked the SII to supply around 141 million doses. The company has also accounted for nearly all of India’s vaccine exports.”

    (Read a most eloquently argued recent opinion on this in The Guardian, discussed below)

    Since the beginning of the pandemic, questions have been raised on how Gavi - The Vaccine Alliance, which is spearheading the COVAX Facility negotiated contracts with vaccine manufacturers. An unprecedented global demand for vaccines, meant an attractive opportunity for manufacturers. Why have COVAX partners, on the back of advance purchase commitments and what appear to be lax terms on questions of intellectual property, for example, not been able to ensure timely access for vaccines? The circumstances would have given COVAX a huge bargaining power. How is it that it has resulted in COVAX struggling at the back of the queue, susceptible to the vagaries of state and corporate commitments, despite promises on procuring in bulk?

    SII has committed to supply more than a billion vaccine doses of AstraZeneca and Novavax to COVAX meant for low and middle income countries including India.

    Take Gavi’s relationship with SII and India - both seem to be characterised by non-transparency. Top Gavi officials have often underscored India’s special status as a vaccine producer. (This may now come to bite.)

    We reported late last year, that the Gavi Board considered a package of support for India that included providing 20% of total AMC doses among other features unique to this proposal. This takes into account, factors including, the epidemiological burden of the disease and the population size. (India has been classified as a AMC country)

    Image credit: Annex A, Gavi Board Report, December 2020

    The AZ-SII arrangement of licensing is being held up as a shining example of cooperation in addressing this pandemic going forward. We are not entirely sure why. (Critics have also pointed out the role of the Gates Foundation in shaping the terms of this deal.)

    A lot of these puzzles will likely unravel in due course, by which time a high price would have already been paid.

    Public statements made by WHO officials associated with the ACT Accelerator, of which COVAX is a part, suggest that authorities were caught off-guard with the constraints facing SII. (One of the biggest short-comings of COVAX was under-estimating the logic of free markets and the resulting bilateral deals.) At a recent briefing, a top WHO official also suggested that price of vaccine doses is not a factor, and that countries prefer access to doses. This is not only untrue, but also insensitive for countries hurting under the worst economic crises in decades.

    The point is, this challenge is bigger than what certain actors did or did not do. This is not only about Gavi, India or SII, but the lack of a global mechanism more than a year to the pandemic.

    We reached out to Gavi to understand the implications of these uncertainties triggered by concerns surrounding the AstraZeneca vaccine, the star of the COVAX portfolio.

    [GHF] 1. Can you clarify what are the liability provisions in the agreement COVAX has had with AZ/SII and AZ/Ox vaccines?

    [Gavi] The foundational goal of COVAX is global equitable access to COVID-19 vaccines, which includes working to ensure that ability to pay is not a barrier to access. As we strive towards this goal at an unprecedented scale and speed, the issue of liability is one of many complex problems for which the world must design new solutions. That is why COVAX has set up a no-fault Compensation Program for the 92 low- and middle-income countries and economies eligible for support via the Gavi COVAX Advance Market Commitment (AMC) of the COVAX Facility – all vaccines distributed through COVAX to AMC economies are covered. The Compensation Program will be funded, and claims met through COVAX donor funding and at no cost to the AMC economies. As the first and only vaccine injury compensation mechanism operating on an international scale, the programme will offer eligible individuals in AMC-eligible countries and economies a fast, fair, robust and transparent process to receive compensation for rare but serious adverse events in connection with the administration of COVAX-distributed vaccines.

    [In addition, and as required by vaccine manufacturers, all participants receiving vaccines through COVAX will sign an indemnity agreement directly with the manufacturers, either on the manufacturer’s standard terms in the case of self-financing participants, or  on the terms of a model indemnity agreed for all AMC economies.]

    [GHF] 2. Is COVAX reviewing AZ vaccines as a part of its broader portfolio based on these emerging concerns?

    [Gavi] The Oxford/AstraZeneca COVID-19 vaccine has received Emergency Use Listing from the World Health Organization and has been approved for emergency use by a number of regulatory authorities. Safety is our paramount concern: we know that national authorities and the WHO are monitoring the situation closely and the COVAX Facility will be following their guidance and recommendation. Currently no causal link has been established between the vaccine and thromboembolic events in individuals, and the vaccine remains an important and effective public health tool in the fight against this pandemic.

    We understand many countries are awaiting further guidance from the WHO, the EMA and other authorities, and we will work with their governments to ensure optimal outcomes for all parties following the issuing of that guidance.

    We also inquired about the mechanism (possibly the COVAX Exchange?) under which European countries, for example, might want to offload AZ doses into the Facility, the question went unanswered.

    Image credit: Jeffrey Czum, Pexels

  • The COVAX Humanitarian Buffer Explained: Gavi

    “The Board of Gavi, the Vaccine Alliance has approved the COVAX Buffer to ensure access to COVID-19 vaccines for high-risk populations in humanitarian settings and enable an emergency release of doses for severe outbreaks. The volume of the COVAX Buffer will be up to 5% of doses procured through the COVAX Facility, thus making up to 100 million vaccine doses available by end of 2021.

    …Gavi supports high-risk populations in humanitarian settings with routine immunisation and outbreak response programmes through its Fragility, Emergencies, Refugees (FER) policy and four emergency vaccine stockpiles – for Ebola, cholera, meningococcal and yellow fever vaccines. Stockpiles are an essential and effective mechanism to enable rapid and equitable access to vaccines and the FER policy facilitates access to vaccines for populations in humanitarian contexts that are otherwise at risk of being left behind. The design of the COVAX Buffer has drawn on the principles of flexibility and exceptionality of these approaches as well as lessons learnt from the investment in stockpiles and FER policy implementation…”

    GAVI

  • WTO TRIPS Council Minutes of the Meetings in late 2020 [IP/C/M/96/Add.1]

    Statements made by countries at these crucial meetings which also discussed the TRIPS waiver proposal.

II. WHAT WE FOUND INTERESTING

NEWS:

  • See How Rich Countries Got to the Front of the Vaccine Line: New York Times

    “..More than half a billion vaccine doses have been administered worldwide so far, and well over three-quarters of them have been used by the world’s richest countries. The reason, experts say, lies in how — and when — deals for doses were struck.

    …Low-income countries made their first significant vaccine purchase agreements in January 2021 — eight months after the United States and the United Kingdom made their first deals, according to data compiled by Unicef…”

    New York Times

  • IMF calls for tax hikes on wealthy to reduce income gap: The Guardian

    This likely took the staunchest critics of the IMF by surprise.

    “The International Monetary Fund has called on governments to close the income gap between the richest and poorest that has worsened during the Covid pandemic, by spending more and taxing wealthy households.

    In a warning that the economic shock triggered by the pandemic could undermine public attitudes to the fairness of taxation and welfare systems and lead to social unrest, the Washington-based organisation said surveys showed governments would have the support of the public if they shifted the burden of taxation away from low and middle earners to better-off members of society.”

    The Guardian

  • The world's poorest countries are at India's mercy for vaccines. It's unsustainable: The Guardian

    Scathing and timely.

    “…It’s somewhat rich for figures in Britain to accuse India of vaccine nationalism. That the UK, which has vaccinated nearly 50% of its adults with at least one dose, should demand vaccines from India, which has only vaccinated 3% of its people so far, is immoral. That the UK has already received several million doses from India, alongside other rich countries such as Saudi Arabia and Canada, is a travesty..

    ….This colossal mess was entirely predictable, and could have been avoided at every turn. Rich countries such as the UK, the US, and those of the EU, and rich organisations such as Covax should have used their funding of western pharmaceutical companies to nip vaccine monopolies in the bud. Oxford University should have stuck to its plans of allowing anyone, anywhere, to make its vaccine. AstraZeneca and Covax should have licensed as many manufacturers in as many countries as they could to make enough vaccines for the world. The Indian government should have never been effectively put in charge of the wellbeing of every poor country on the planet…”

    The Guardian Opinion by Achal Prabhala and Leena Menghaney

  • Pfizer Demands South African Ministers Personally Sign Vaccine Pact, Bloomberg

    Companies such as Pfizer continue to exploit the sellers market in today’s times. We are wondering if countries can bring in legal measures to counter such tactics.

    “Pfizer Inc. is demanding that South Africa’s health and finance ministers personally sign a Covid-19 vaccine-supply agreement so that it is indemnified from any claims made against it in the country regarding the shot.

    The demand is contained in a March 24 letter from South Africa’s Health Minister Zweli Mkhize to his finance counterpart Tito Mboweni, seen by Bloomberg and confirmed by the National Treasury. Pfizer was not satisfied by assurances that the signature of the country’s health director general was sufficient to guarantee the indemnity, Mkhize said.”

    Bloomberg

  • How to solve the mystery around Covid-19's origin: CNN Opinion

    The house view is that WHO DG Tedros used the initial virus-origins report as a political tool. We got a very different sense from listening to scientists who worked on the report. And we are glad, that other commentators have discerned this.

    “…Produced by a team of individual experts, half Chinese and half international, the report does not reflect the investigation or the conclusions of WHO Director-General Tedros Adhanom Ghebreyesus, who upon receiving the report called for "future collaborative studies to include more timely and comprehensive data sharing."

    In fact, member states have not given the WHO authority to conduct more independent investigations, unlike powers given to the International Atomic Energy Agency (IAEA), for example. There is no secret WHO intelligence-gathering force and, under international law, no threat of sanctions if China does not comply with WHO's requests for information or access. The International Health Regulations, despite a lofty name and binding international legal status, give the WHO few powers in collecting and reporting data against the wishes of member states. The agency can privately use diplomacy with governments or critique countries publicly -- but these only go so far.”

    CNN

  • Vietnam asks for foreign support in procuring COVID-19 vaccines: Reuters

    The reason we find it interesting is, because Vietnam does not support the TRIPS waiver proposal at the WTO.

    “Vietnam has appealed to diplomats from the United States, European Union and Japan to help it secure supplies of COVID-19 vaccines, as part of efforts to acquire the 150 million doses needed to cover its adult population.”

    Reuters

  • Sinopharm, Sinovac COVID-19 vaccine data show efficacy: WHO - Reuters

    “Chinese vaccine makers Sinopharm and Sinovac have presented data on their COVID-19 vaccines indicating levels of efficacy that would be compatible with those required by the World Health Organization, the chair of a WHO advisory panel said on Wednesday.

    The WHO’s Strategic Advisory Group of Experts (SAGE) hopes to issue recommendations on those vaccines by the end of April, its chair Alejandro Cravioto, told a Geneva news briefing.

    “The information that the companies shared publicly at the (SAGE) meeting last week clearly indicates that they have levels of efficacy that would be compatible with the requirements that WHO has asked for this vaccine,” Cravioto said, referring to the group of independent experts’ closed-door meeting.”

    Reuters

    Link to the SAGE briefing on March 31, 2021.

  • The rise and fall of a coronavirus ‘miracle cure’: Politico

    A must-read story that connects the dots across the world. It captures our desperation for cures during COVID-19

    “The bombshell arrived on December 8, when U.S. physician Pierre Kory spoke before a Senate hearing on early outpatient treatment for coronavirus. Ivermectin, alongside other medicines such as vitamin C, zinc and melatonin, could "save hundreds of thousands of people," he testified, citing more than 20 studies.

    Kory also questioned why remdesivir — a pricey drug that has shown some limited efficacy in severely ill coronavirus patients — was able to secure a compassionate use authorization from U.S. regulators while ivermectin was not.

    Kory's appearance reverberated across the globe. A YouTube video of his testimony went so viral that it was removed under the platform's COVID-19 disinformation policy. As Chaccour put it, the video immediately prompted some people to ask: "Why are they killing us if there's this life saving drug out there? Why is Big Pharma pushing for their own solutions?"

    "And that sparked the whole second wave of interest," said Chaccour.

    Many miles away, in South Africa, a black market for ivermectin soon emerged. In Romania, stocks of ivermectin at both human and veterinary pharmacies were reported to be depleted in January.”

    Politico

  • Carl Bildt, former Prime Minister of Sweden, appointed WHO Special Envoy for the ACT-Accelerator: WHO news release

    “Carl Bildt joins the ACT-Accelerator at a pivotal time when the world rolls out vaccines against COVID-19, introduces new diagnostics and scales up life-saving oxygen and corticosteroids for severe disease, while addressing the uneven distribution of vaccines globally and the emergence of new variants of concern.”

    WHO

  • Why indoor spaces are still prime COVID hotspots: Nature

    One of the most definitive stories on airborne COVID transmission with voices from building and construction engineers.

    “A stark message from the WHO would ensure that national health authorities take notice, says Jimenez. Australia, the Netherlands and some other nations still do not acknowledge in their public statements that airborne transmission has a significant role in spreading the SARS-CoV-2 virus.”

    Nature

FROM THE JOURNALS / REPORTS:

  • WHO guidance on ethics in outbreaks and the COVID-19 pandemic: a critical appraisal: BMJ

  • COVID-19 and Its Effect on Inequality and Democracy: The Council on Foreign Relations

    “The novel coronavirus pandemic has wreaked havoc on public health in most countries, but it has caused particular destruction in five of the most populous and powerful democracies in the world: the United States, Brazil, India, Indonesia, and the Philippines. These states have five of the highest death tolls and caseloads from COVID-19 of any countries, and all have struggled to control the pandemic….

    ….Instead, the vast social and economic inequalities in these five ethnically and racially diverse countries have made the pandemic harder to control. These states have failed to handle the novel coronavirus in part because they have never addressed their historical internal divides, which COVID-19 has brutally revealed. In addition, leaders in these states who have attacked political systems and social cohesion have hindered the pandemic response…”

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III. THE WEEK IN TWEETS

Fatima Hassan, Founder, Health Justice Initiative South Africa, says:

Justin Amash, an American politician says:

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