Tuesday’s Weekly Primer: The concerted push to address vaccine production shortages

Originally published March 9th, 2021 on Geneva Health Files

POLICY UPDATES

WHO’s push for unblocking production shortages

• Even the staunchest critics of WHO, will have taken notice on the regularity and determination with which DG Tedros is speaking plainly on quickly boosting production capacities to meet the demand for COVID-19 vaccines.
• Last week, he highlighted barriers to increasing speed and volume of production, called out export bans and launched a renewed call for a waiver of the TRIPS obligations. Irrespective of the consequences, it is significant that the top boss of WHO is pushing for the contentious waiver proposal. Reportedly, some donor countries of WHO, who are opposing the waiver proposal at WTO, were not happy with WHO’s support for these discussions. It is, despite this opposition that Tedros continues to raise these prickly matters.
• To address the production shortages, in his remarks, Tedros suggested:

1. Connecting companies who are producing vaccines with other companies who have excess capacity to fill and finish. (He cited the “part of the deal between Johnson & Johnson and Merck announced this week is for Merck to provide fill and finish for the J&J vaccine.”)

“WHO can support this process by identifying gaps and providing a “matchmaking” service between vaccine producers and companies with capacity.”

2 . Using bilateral technology transfer, through voluntary licensing from a. company that owns the patents on a vaccine to another company who can produce them. Significantly, he also highlighted the disadvantage of a lack of transparency with this approach (cited the example of AstraZeneca, “which has transferred the technology for its vaccine to SKBio in the Republic of Korea and the Serum Institute of India, which is producing AstraZeneca vaccines for COVAX”). (As an aside, see this story from a subsequent briefing where scientists who worked on AstraZeneca and Pfizer/BioNtech vaccines did not believe patents were a barrier for access to vaccines.)

3. The third approach is what he called “coordinated technology transfer”. “This would involve universities and manufacturers licensing their vaccines to other companies through a global mechanism coordinated by WHO, which would also facilitate the training of staff at the recipient companies, and coordinate investments in infrastructure.” (Cited the example from H5N1 influenza in the mid-2000s: “WHO supported technology transfer for the production of pandemic flu vaccines to 14 countries, increasing global capacity by more than 700 million doses,” he said.). This approach could be read as a push for the COVID-19 Technology Access Pool.

It was pointed out by one commentator on twitter, why did he not name C-TAP here, as he has done in the past.

This omission of not mentioning C-TAP is perhaps not so surprising. After all, IFPMA, a key partner of the ACT Accelerator has long dismissed C-TAP.

Also read this in conjunction with the on-going Global C19 Vaccine Supply Chain & Manufacturing Summit organized by COVAX partners including IFPMA.

This summit, convened under Chatham House rules, is meant to “provide a platform to explore a range of solutions to address bottlenecks both short-term and longer term and lead to a series of recommendations on the priority areas for monitoring and/or action,” according to a concept note of the event.

1. Here is his final suggestion on addressing challenges on making vaccines available: “many countries with vaccine manufacturing capacity can start producing their own vaccines by waiving intellectual property rights, as provided for in the TRIPS agreement.”

• This clear articulation from WHO of what is necessary 14 months into the pandemic, especially from its industry partners is important. However, as has become obvious, especially in the last one year, WHO does not truly control these difficult conversations. Take the manufacturing summit for example, where WHO professed to play “matchmaker”. It appears WHO is very much on the sidelines of what seems to be an industry-led initiative. Experts believe that inflexible industry positions on sharing technology or know-how, have contributed towards scarcity of vaccine production. How then, can this industry-brokered process yield solutions on addressing production shortages? (Few details emerged from the Summit before this edition went to print. An industry-organized press briefing is scheduled for later.)

Image Credit: Pexels Francesco Ungaro 96381

• Discussions at WTO on the pandemic response
• As an adjudicator of international trade rules, WTO needs to have a seat at the table on these discussions that bring together vaccine makers, researchers and international organizations. This is particularly important in the light of export restrictions imposed by WTO members including the EU.
• However, at the on-going manufacturing summit to come up with solutions for production shortages of COVID-19 vaccines, it appears that WTO was initially not a part of the summit.
• Subsequently, it emerged that WTO’s new boss Ngozi Okonjo-Iweala has indeed been a part of these discussions at the on-going manufacturing summit. According to sources present at a meeting this week, Ngozi reportedly said that WTO has a mandate on these issues and needs to be at the table.
• In general, manufacturers have already highlighted the impact of export restrictions that are beginning to impinge on vaccine production. Some vaccines need numerous components sourced from across the world, in a multi-country supply chain.
• (Apart from the EU’s export authorization scheme, the US also announced measures to restrict export of raw materials. The Biden administration has decided to invoke the Defense Production Act to prevent exports of certain materials needed to manufacture vaccines, also to prioritise access to the production of the Pfizer vaccine.)
• Speaking of the summit, Ngozi said that manufacturers want WTO to address issues of bureaucracy and export restrictions that are affecting vaccines production.
• On the TRIPS waiver proposal, according to sources who were present at a meeting this week, the new DG while supporting the discussions on the waiver, seems to suggest addressing the access to vaccines separately. She took cognizance of the sentiment of the waiver proposal that is shaped by the history of previous crises including HIV and H1N1. Ngozi clearly stated her support for the process, but asked for more “nuance” in the discussions.
• The DG was reportedly of the view that the waiver collectively addresses therapeutics, diagnostics and vaccines, although their manufacturing processes are very different. She suggested to have the TRIPS waiver discussions “a little bit later”, and advised that a different approach should be taken for vaccines taking into consideration the “facts of vaccine production” including the time taken to set up manufacturing sites. The priority is to increase volumes of production for vaccines. Intellectual property alone will not address manufacturing capacity, she seemed to say, according to sources.
• Also, see this letter sent by Knowledge Ecology International when DG Ngozi took over last week. It includes suggestions on responding to the pandemic by using provisions at WTO, (excluding the TRIPS waiver proposal). Some of these include support for countries “opting in” under the TRIPS Agreement Article 31bis, patent law exceptions to address pandemics or other emergencies, new modalities to facilitate the sharing of manufacturing know-how in a pandemic; and working towards a WTO agreement on the supply of public goods.

This story was updated on March 10, to link to the following documents:

Global C19 Vaccine Supply Chain & Manufacturing Summit:

Towards Vaccinating The World Landscape of Current COVID-19 Supply Chain and Manufacturing Capacity, Potential Challenges, Initial Responses, and Possible “Solution Space” — a Discussion Document

Appendix

II. WHAT WE FOUND INTERESTING

NEWS:

• International megatrial of coronavirus treatments is at a standstill: Science
• This came as news to us.
• “The only global trial of potential COVID-19 treatments is languishing. The World Health Organization’s (WHO’s) Solidarity trial, set up last year to quickly test potential COVID-19 therapies with tens of thousands of patients, produced headlines in October 2020 when it showed that four candidate treatments offer little benefit. But since then, it hasn’t launched any new tests. On 27 January, John-Arne Røttingen, who works at Norway’s foreign ministry and chairs the trial’s executive group, pulled the plug on the study’s only remaining arm, which tested the antiviral remdesivir. “The Solidarity trial is now on pause,” he says.”
• Science
• How elimination versus suppression became Covid’s cold war: The Guardian
• Fascinating, clear writing in the midst of this cacophonous news cycle.
• … “And so the world is cleaved in two, with each bloc operating according to a different set of assumptions, in a kind of public health rerun of the cold war. One bloc assumes that Covid-19 can be eliminated, the other that it can’t. The latter thinks the former is chasing an impossible utopia. The former thinks the utopia could be achieved if only everyone pulled together…”
• The Guardian
• Unredacted Pfizer contract with Dominican Republic, shows broad indemnity provisions for COVID-19 vaccine sales: Knowledge Ecology International (KEI)
• KEI got hold of the “binding term sheet” between Pfizer/BioNTech and the Dominican Republic for supply of COVID-19 vaccines, through the freedom of information law in the Dominican Republic.
• “…the Dominican Republic will “indemnify, defend, and hold harmless” Pfizer even if the company makes a mistake in the “[…] manufacture, labeling, packaging, transport, storage, distribution, marketing, promotion, sale, purchase, licensing, donation, dispensing, prescribing, administration, provision, or use of the vaccine.” This includes, for instance, failures to keep the vaccines at the recommended temperatures during transportation to the country. The provision is yet another example of how Pfizer is using national governments to de-risk the commercialization of their vaccine.”
• KEI
• The Dark Side of Bill Gates’s Climate Techno-Optimism: The New Republic
• The focus on Bill Gates continues. Read this in-depth story that draws parallels between Gates’ intervention in the vaccines industry and his proposed solutions to the climate crisis.
• “…In general,” Gates writes, “the government’s role is to invest in R&D when the private sector won’t because it can’t see how it will make a profit. Once it becomes clear how a company can make money, the private sector takes over.” Socialize the risk, in other words, and privatize the reward. Gates has taken a similar approach to vaccine development, engineering public-private partnerships that — while making impressive progress vaccinating millions around the world — have also left pharmaceutical companies calling the shots and reaping profits…
• ….In the world of climate discourse, Gates is what’s known as a techno-optimist. But his theory of change is one of benevolent intellectual property domination. Vaccine apartheid has been a preview for climate apartheid, and the perils of letting intellectual property rights determine who gets access to critical technologies. If Gates is able to perceive the huge costs of this model, he hasn’t let on…”
• Why Virus Variants Have Such Weird Names: New York Times
• A very interesting story discussing our current realities and tracing it back to the past.
• “…Naming diseases was not always so complicated. Syphilis, for example, is drawn from a 1530 poem in which a shepherd, Syphilus, is cursed by the god Apollo. But the compound microscope, invented around 1600, opened up a hidden world of microbes, allowing scientists to start naming them after their shapes, said Richard Barnett, a historian of science in Britain.
• Still, racism and imperialism infiltrated disease names. In the 1800s, as cholera spread from the Indian subcontinent to Europe, British newspapers began calling it “Indian cholera,” depicting the disease as a figure in a turban and robes…”
• New York Times
• A Silicon Valley Memo on China’s Tech Global Dominance Has Ramifications in International Geneva: The Geneva Observer
• “On techno-democracies” an American design for an international grouping of countries to counter China. According to the author, this could have ripple effects in multilateral Geneva.
• Joint Statement Initiatives will erode WTO’s multilateral rules-based architecture: Third World Network
• A story which discusses a recent proposal at the WTO by India and South Africa: The Legal Status Of ‘Joint Statement Initiatives’ And Their Negotiated Outcomes
• “India and South Africa have challenged the legal status of the proposed informal Joint Statement Initiatives (JSIs) on electronic commerce, investment facilitation, MSMEs, and domestic regulation in services, on grounds of their inherent contradiction with the core principles of the WTO’s Marrakesh Agreement, as well as their systemic and development implications.”
• Third World Network
• EU countries look abroad for vaccines as doubts in Brussels grow: Politico
• Excellent graphics in this story. Check it out.
• “..In just the last few days, Denmark, Austria, Poland, Slovakia and the Czech Republic have all joined Hungary in breaking ranks with the EU’s vaccination strategy by going beyond Europe’s borders for doses.”
• Politico

FROM THE JOURNALS / REPORTS:

• Covid-19, trust, and Wellcome: how charity’s pharma investments overlap with its research efforts: British Medical Journal
• Must read by Tim Schwab: “The major funder of health research stands to gain financially from the pandemic, raising questions about transparency and accountability”
• …“At the same time, The BMJ finds, Wellcome itself holds investments in companies producing these same treatments. Financial disclosures from late 2020 show that Wellcome has a £275m (€318m; $389m) stake in Novartis, which manufactures dexamethasone and is investigating additional therapeutics. And Roche, in which Wellcome holds a £252m stake, is helping to manufacture monoclonal antibodies with Regeneron. Both Roche and Novartis report having had conversations with WHO’s ACT Accelerator about their therapeutic drugs.”
• British Medical Journal
• EU risks global public health in its protection of big pharma monopolies: Corporate Europe Observatory
• As the TRIPS waiver talks at WTO continue this month, a timely report that casts light on EU’s role in protecting intellectual property over the decades in multiple jurisdictions and forums.
• COVID-19 and the cost of vaccine nationalism: RAND Europe
• Some jaw-dropping projections here.
• Resource — Research Synthesis: Compulsory Licensing from The Graduate Institute

Subscribe to the Geneva Health Files newsletter: https://genevahealthfiles.substack.com/subscribe

Write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com

Follow us on Twitter: @filesgeneva & @pretpat