Make way for the COVAX Manufacturing Taskforce

Geneva Health Files
15 min readApr 22, 2021

Newsletter Edition #47 [The Weekly Primer]

Originally published April 13th, 2021 on Geneva Health Files.

Hi,

A few weeks ago, we reported on a “vaccines capacity connector” taking shape at WHO. (See WHO donors seek a new tech transfer hub under ACT-A, C-TAP sidelined). This has now morphed into the “COVAX manufacturing task force” flagged by DG Tedros this week.

Ostensibly the goal is to “quickly” find solutions to address the vaccine crunch. However, as we know in global health these days, “quick” responses threaten to stay on and perpetuate status quo.

We are here, listening to astute readers and informed sources to help understand these unfolding dynamics that invariably have more than meets the eye.

A couple of housekeeping matters.

It was brought to our attention that one of the stories we discussed in last week’s newsletterSinopharm, Sinovac COVID-19 vaccine data show efficacy: WHO — Reuters”, is likely to mislead readers. It is important to emphasize that immunization experts from the SAGE group that met in March, 2021, sought additional data on these vaccine dossiers. It was suggested that the Reuters story did not sufficiently highlight the need for data before authorization of these vaccines, and is hence likely to be misunderstood.

Also sharing our story from last Friday: WHO’s “Bretton Woods Moment” Dimmed by Member States’ Reluctance To Pay Up More. Sign up and have a read!

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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 COVAX Manufacturing Task Force
  • While the COVAX Facility reached a milestone of making vaccine doses available (38 million) in more than 100 “economies”, as a press statement articulated last week, the questions on its effectiveness and limitations continue to get louder.
  • At the Africa’s Vaccine Manufacturing Virtual Conference, organized by Africa CDC, Andrew Witty, ex-CEO of GSK, and a former special envoy of the ACT Accelerator acknowledged the limitations of the COVAX Facility.
  • To be sure, the uncertainties facing supplies of vaccines have been confirmed at the highest levels. Last week, Seth Berkley, CEO of Gavi — The Vaccine Alliance said that while efforts will made to make available 2.3 billion doses by the end of 2021, the first six months of 2021 will only see 20% of those doses reaching countries. This is lower than initial estimates. In addition, even these existing projections are subject to changes on account of production uncertainties.
  • (COVAX was expecting to distribute almost 100 million doses by the end of March, but due to a marked reduction in supply, only 38 million doses were distributed. Authorities hope to catch up in April and May. More than 700 million vaccine doses have been administered globally, but over 87% have gone to high income or upper middle-income countries, while low income countries have received just 0.2%.)
  • As we reported earlier, the response of global health agencies to address these shortages has been to go down further on the path, which created these uncertainties in the first place — namely tightly controlled bilateral deals that have failed to expand manufacturing of vaccines at the pace needed to meet current global demand.
  • In his remarks this week, Tedros formally mentioned the COVAX manufacturing task force.

Earlier today I joined several leaders from Africa for a discussion about how to increase local vaccine production.

It was encouraging to hear Rwanda, Senegal and South Africa speak about the concrete steps they have so far taken to start local production.

Early in the pandemic, African countries came together to agree on a coordinated continental approach to the pandemic, and now they’re coming together for a coordinated approach to scaling up manufacturing.

Investing in sustainable and secure domestic manufacturing capacity and national regulatory authorities is critical for providing essential immunization programmes, and for building strong, resilient health systems against the inevitable health emergencies of the future.

To address this challenge, WHO and our partners have established a COVAX manufacturing taskforce, to increase supply in the short term, but also to build a platform for sustainable vaccine manufacturing to support regional health security.

WHO is also ready to provide immediate technical support to assist countries in assessing the feasibility of local production, and in accessing technology and know-how.

Last week, senior WHO officials seemed to be under pressure to respond to numerous questions on technology transfer. They deftly sidestepped all questions on technology transfer.

  • At the press briefing (April 9), Gavi’s Berkley had said, “There is a COVAX manufacturing task force that is looking at technology transfer and how to expand production, but right now one of the worries is limitations in supplies.”
  • This response indicates the short-sightedness in the prevailing narrative around production shortages. It is plainly obvious that the limitation in supplies faced by the world today, is a result of the lack of strategic efforts to expand production in 2020, if not earlier.
  • On the COVAX manufacturing taskforce, we raised a question on whether it will undermine the COVID-19 Technology Access Pool. Top WHO official, Sowmya Swaminathan, Chief Scientist of the organization, told us that WHO is working with CEPI, Gavi and UNICEF on the taskforce.

The immediate goals of the taskforce will be to address shortages of raw materials needed to manufacture vaccines and also to work with countries to ensure that there are no export restrictions on these materials.

The medium term goal will be expand the manufacturing of approved vaccines. The idea is to encourage more manufacturers to strike voluntary licensing deals (She cited the AstraZeneca model). She also added that there is a “close link” between the C-TAP and the manufacturing taskforce. C-TAP will work closely with the Medicines Patent Pool to enable licensing arrangements between manufacturers. The goal is to ensure that “additional doses produced will have to go through COVAX to ensure equitable distribution.”

The long-term goal of the taskforce is to expand basic manufacturing capacities in Africa, for example, including by working on investments, business plans for sustainability and technology transfer to service not only the production of COVID-19 vaccines but also other diseases.

The coming weeks and months will show us how such a taskforce will operate and if it will be able to meet production challenges to meet growing demand for vaccines.

  • It has been pointed out that COVAX was set up only to service the demand side of the equation. Without addressing severe supply constraints, propping up solutions such as vaccine donations and bilateral licensing deals will not even come close to meeting the global demand for more than 10 billion doses of vaccines.
  • And yet, global health leaders insist that “COVAX works”. It’s a strong mechanism that can distribute vaccines faster and more efficiently than any other mechanism, WHO DG said. This is partly true.But, logistics alone cannot solve the problem of access to vaccines.
  • Tedros also acknowledged, “The problem is not getting vaccines out of COVAX; the problem is getting them in.” Sure, which is why questions have been raised on why COVAX partners CEPI, Gavi and the industry, have not been successful in getting “vaccines in”.
  • We are also, noticing the rising indictment of vaccine diplomacy initiatives.

“We understand that some countries and companies plan to do their own bilateral vaccine donations, bypassing COVAX for their own political or commercial reasons. These bilateral arrangements run the risk of fanning the flames of vaccine inequity,” Tedros said.

  • Unraveling the real intent of vaccine diplomacy is complex with many unstated motivations including political, economic and social. For now, it may have saved some lives.
  • To be sure, WHO is right in treating “vaccine donations” and “vaccine diplomacy” in the same manner.
  • “This is a time for partnership, not patronage. Scarcity of supply is driving vaccine nationalism and vaccine diplomacy,” Tedros also noted last week.
  • As has been pointed earlier, it is this politics of patronage that is the fundamental basis of initiatives such as the COVAX Facility and its parent — the ACT Accelerator.
  • Even after 135 million confirmed cases of COVID-19 and deaths touching 3 million world-wide, one hopes that leaders across the world in politics, industry and international institutions will take decisive steps to challenge status quo and use tools that are available to unclog supply chains and spur new production pathways.
Image credit: Photo by rovenimages.com from Pexels

“WHO, OIE and UNEP call on national competent authorities to suspend the trade in live caught wild animals of mammalian species for food or breeding purposes and close sections of food markets selling live caught wild animals of mammalian species as an emergency measure.

Although this document focuses on the risk of disease emergence in traditional food markets where live animals are sold for food, it is also relevant for other utilizations of wild animals. All these uses of wild animals require an approach that is characterized by conservation of biodiversity, animal welfare and national and international regulations regarding threatened and endangered species.”

II. WHAT WE FOUND INTERESTING

NEWS:

“The contracts the Trump administration signed with the vaccine manufacturers prohibit the U.S. from sharing its surplus doses with the rest of the world. According to contract language Vanity Fair has obtained, the agreements with Pfizer, Moderna, AstraZeneca, and Janssen state: “The Government may not use, or authorize the use of, any products or materials provided under this Project Agreement, unless such use occurs in the United States” or U.S. territories.

The clauses in question are designed to ensure that the manufacturers retain liability protection, but they have had the effect of projecting the Trump administration’s America First agenda into the Biden era. “That is what has completely and totally prohibited the U.S. from donating or reselling, because it would be in breach of contract,” said a senior administration official involved in the global planning effort. “It is a complete and total ban. Those legal parameters must change before we do anything to help the rest of the world.” ..”..

…” A series of scares in the early 2000s, including the 2001 anthrax attacks on members of Congress and the press and the 2004 worldwide outbreak of H5N1 “bird flu,” prompted Congress to pass the Public Readiness and Emergency Preparedness (PREP) Act. The 2005 law gives manufacturers of vaccines and therapeutics developed in response to public health emergencies sweeping protection from liability, and makes the U.S. government a guarantor of that protection.

The law provides an “almost Star Trek–level ‘shields up,’” said Nicholas Pace, a senior social scientist at the RAND Corporation. But “the moment that vial walks across the border, PREP has no effect. The cross-border liability problem is a huge one.”..”

Vanity Fair

A global pandemic treaty won’t work until leaders realise the benefits of solidarity: The Guardian [Opinion]

  • Its all politics — fundamental to any technical or legal discussion.

“One of the key lessons learned from Covid-19 has been that politics drives epidemics. Political will to manage an outbreak is crucial to the success of any technical disease control intervention. This also stands for global governance of disease: the best norms and international law are only as effective as the political credentials given to them. A significant critique of the IHR is that it is a technical and legal tool, outlining government’s responsibilities to prevent, detect and respond to an emerging pathogen, without any incentive or enforcement mechanism to do so. Beyond public shaming, there are few ramifications for governments flouting the law. If the proposed pandemic treaty can bring greater political commitment to the established law and norms in global health security and is able to hold governments to account, it would certainly be the holy grail for pandemic preparedness.”

The Guardian

Brussels fails to win round critics of tighter Covid vaccine export curbs: Financial Times

  • The diversity in policy responses to the pandemic within the EU.

“ Four EU countries have rebelled against Brussels’ move to step up export restrictions on vaccines, in the clearest sign yet of the bloc’s internal tensions over the policy. The group, which comprises the Netherlands, Belgium, Ireland and Sweden, did not muster enough support to block the measures, which were announced by the European Commission last month. But the no-votes underlined fears in some EU capitals that the curbs are damaging the bloc’s reputation as a reliable player in the medical supply chain.”

“…. The opposition from Belgium and the Netherlands is notable given their status as major vaccine producers. The two countries host the two EU plants producing the raw substance for the Oxford/AstraZeneca jab, while Pfizer produces its vaccine in Puurs, Belgium….”

Financial Times

WTO-TRIPS waiver: “Third Way” Set to Reinforce Status Quo? — Third World Network

  • All you want to know about the WTO meeting later this week that brings together vaccine manufacturers and members.

“…Interestingly, the DG seems either oblivious to the fact that the WTO can only make its contribution to COVID-19 through its binding rule-making process, or by blatantly pursuing a top-down agenda to undermine the actual contribution that the WTO could make through the TRIPS waiver.”

“…The absence of the former WTO TRIPS Council chair Ambassador Xolelwa Mlumbi-Peter of South Africa, who has steered the TRIPS waiver discussions, in the list of participants while including the current chair Ambassador Sorli suggests a lop-sided and skewed agenda, in favour of maintaining the status quo, said another participant, who asked not to be quoted…”

“…Absent from the agenda is strong representation from the 58 co-sponsors of the TRIPS waiver proposal in each of the sessions, and civil society groups that have played a crucial role in highlighting the challenges and causes of inequitable access…”

Third World Network

Attempts to slow down discussions on TRIPS waiver at WTO: Third World Network

  • Keep in mind that the WTO TRIPS Council is chaired by Ambassador Dagfinn Sorli from Norway.

“More recently it has emerged that Norway may actually be a fierce critic of the TRIPS waiver proposal alongside the US, the European Union, the United Kingdom, Japan, Australia, Canada, Switzerland and Singapore.

In response to a letter dated 16 February from civil society from the Global South, Norway’s Prime Minister Ms Erna Solberg wrote on 25 March that “in Norway’s view, the scope of the proposed TRIPS waiver is broad, and the effects will be uncertain …,” a statement that appears to reflect that Norway has already made up its mind to oppose the waiver.

The Norwegian prime minister said that “the discussions in the WTO since last October have shed more light on the potential impacts and implications of such a waiver,” which seems totally incorrect as the opponents to the TRIPS waiver have adopted “stonewalling and diversionary” tactics, said people familiar with the development.”

Third World Network

The G7 must push for global vaccination. Here’s how it could do it: The Guardian

  • A bunch of good ideas here, while recognizing limitations of current approaches.

….”So it falls to the richest countries to trigger two additional sources of funding required until Covid is eradicated. In the 1960s, the international community approved a special levy on its members to fund smallpox eradication. Currently, UN peacekeeping operations and $1bn of WHO contributions are covered by similar levies based on a nation’s ability to pay as measured by its national income, debts owed and levels of wealth and poverty.

A more equitable burden-sharing would also weigh the differential gains to richer countries from the resumption of trade and the special privileges of G7 and G20 membership. Under such a formula, the US might contribute about 25% of the vaccination fund, and the UK, France, Germany, Italy and Japan between 4% and 7% each, so the poorest countries are exempt. Here the G7 is critical: its members should declare that they will contribute their full share, totalling 60%. If they did so, China, Russia, Scandinavia and the oil states would feel bound to follow….”

“….Home to the major vaccine developers, the G7 countries are in the best position to agree to transfer vaccine technology to low-income countries. The temporary waiver of patents proposed by the People’s Vaccine Alliance will help Africa create its own manufacturing facilities and end months of vaccine nationalism…”

The Guardian

Hard choices emerge as link between AstraZeneca vaccine and rare clotting disorder becomes clearer: Science

“… “In this sort of gradual sliding curve of benefit-risk balance, there’s no sudden point at which it becomes safe or unsafe,” Spiegelhalter says. “This is a judgment.” But for now the numbers suggest that, even for young people, the vaccine is a net benefit for the vast majority. Getting vaccinated also provides protection to other people, Spiegelhalter says: “I think that’s an aspect that has not been emphasized enough.”….”

Science

Kati Kariko Helped Shield the World From the Coronavirus: New York Times

  • Inspiring. Why we must stay the course!

“…“There’s a tendency when scientists are looking at data to try to validate their own idea,” Dr. Langer said. “The best scientists try to prove themselves wrong. Kate’s genius was a willingness to accept failure and keep trying, and her ability to answer questions people were not smart enough to ask.”..”

New York Times

“Gates’s marquee Covid-19 initiative started relatively small. Two days before the WHO declared a pandemic on March 11, 2020, the Bill & Melinda Gates Foundation announced something called the Therapeutics Accelerator, a joint initiative with Mastercard and the charity group the Wellcome Trust to identify and develop potential treatments for the novel coronavirus. Doubling as a social branding exercise for a giant of global finance, the Accelerator reflected Gates’s familiar formula of corporate philanthropy, which he has applied to everything from malaria to malnutrition. In retrospect, it was a strong indicator that Gates’s dedication to monopoly medicine would survive the pandemic, even before he and his foundation’s officers began to say so publicly.”

FROM THE JOURNALS / REPORTS:

“What most often matters is finding contingent, circumstantial or particular truths about what it takes to achieve equity at a place and time — and subsequently, finding regularities; finding the universal in particular.4–6 If we want to serve our mission, our efforts must begin with a concern for how knowledge leads to equity….”

“….This is not to pitch one use of knowledge against another. The principle of subsidiarity is not so much about what should be done or not done, as it is about what should be prioritised. It is a call to rethink our relative focus, emphasis, priority, gaze. It is a call to default to the local gaze; to take the imaginative leap that allows a foreign (or subsidiary) actor to assume, speak or write from a local (or primary) pose. It is a call to reorder the hierarchy of rigour and value that shape our assumptions about knowledge; to recognise where the vast bulk of knowledge that is used to advance equity in global health is to be found. It speaks to an intellectual deficit in academic global health…”

Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine? — Approximating the funding to the University of Oxford for the research and development of the ChAdOx vaccine technology: Medrxiv

“Our study identified that public funding accounted for 97.1–99.0% of the funding towards the R&D of ChAdOx and the Oxford-AstraZeneca vaccine. We furthermore encountered a severe lack of transparency in research funding reporting mechanisms.”

COVAX a global multistakeholder group that poses political and health risks to developing countries and multilateralism: Friends of Earth International

  • A much needed report that clinically parses through the many inherent contradictions in the model of multitakeholderism in pandemic response.

III. WHAT WE ARE WATCHING:

IV. THE WEEK IN TWEETS

Truth in a tweet. Twitter star Eric Topol:

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Geneva Health Files

A newsletter from the capital of global health, reporting on politics, policies and power.