AstraZeneca vaccine: a regulatory test; The new ACT-A strategy

8 min readApr 17, 2021

Newsletter Edition #39 [The Weekly Primer]

Originally published March 16th, 2021 on Geneva Health Files

Hi,

The pandemic has torn asunder many assumptions, including the primacy of science in certain societies. We know how many wealthy countries underestimated their assessments of risk when the pandemic was taking shape early last year.

A string of European countries and others have temporarily halted the administration of the AstraZeneca vaccine on the back of certain events. While investigations are underway, authorities suggest that the events are likely not linked to the vaccine itself. The European Medical Agency, a Stringent Regulatory Authority, and WHO are currently reviewing evidence and will arrive at a policy decision that may inform the future use of the vaccine. WHO has so far maintained that the benefits of the vaccine far outweigh the risks.

The implications of how this vaccine, and the others, will be perceived are likely to be critical to fight vaccine hesitancy the world over. Inevitably it will also set off discussions on liability arising from such events. (My learned colleagues in the EU point out that there are protections on product liability, for example. This may well be a test case for what’s to come.)

As has been pointed out, the AZ vaccine has been the backbone of The COVAX Facility that aims to service large parts of the developing world. So, while rich countries may decide against the use of the vaccine, other countries may not have that choice. In fact, poorer countries may even come to gain from this discretionary policy of rich countries. This will also depend how excess doses be routed through the COVAX Facility, for example.

We have reported on the pressures faced by regulators such as the EMA. The decision on the AZ case will likely set a precedent on how perceived uncertainties around vaccines will be handled by regulators and global health agencies. We are looking to speaking with vaccine manufacturing experts and liability insurers. Suggestions welcome.

Finally, we remind our regular readers that to access The Friday Deep Dives, later this week, consider subscribing soon. We would very much like to share our reporting efforts with you. We have a few important stories coming up that you cannot miss!

Signing up before March 31 will enable you to take advantage of our special launch offers that include lifetime discounts. In the current transition period, our readers will continue to have access to our analysis, albeit with a delay, while they make their transition to becoming paid subscribers.

(We have made public our exclusive story from last week on Could Vaccine Nationalism Spur Disputes At The WTO. Check it out!)

Questions? Just hit reply to this email.

Best,

Priti

I. POLICY UPDATES

The Quad Vaccine Partnership: The White House press release

Clearest example of how health is casting geopolitics into new configurations. [U.S., Japan, India, Australia]

“Quad partners are working collaboratively to achieve expanded manufacturing of safe and effective COVID-19 vaccines at facilities in India, prioritizing increased capacity for vaccines authorized by Stringent Regulatory Authorities (SRA). Quad partners will address financing and logistical demands for production, procurement, and delivery of safe and effective vaccines. Quad partners will work to use our shared tools and expertise, through mechanisms at institutions including the United States Development Finance Corporation (DFC), Japan International Cooperation Agency (JICA), and, as appropriate, Japan Bank of International Cooperation (JBIC), as well as others.”

ACT-A prioritized strategy and budget for 2021: WHO

Riding on $11 billion from donors and refreshed priorities, the ask from the ACT Accelerator is now down to $22.1 billion (from $38 billion last year) as per a new investment case released this week. We bring you a few issues that we found interesting.
The document provides a break up of funding gaps across the pillars of the ACT Accelerator. The epidemiological assumptions underlying ACT-A investments are also indicated.
Precious little has so far been said on the Health Systems Connector (HSC) under the ACT-A. There is some discussion on it in this document. Take a look.

“The primary role of HSC is not to provide a direct source of financing for health systems strengthening beyond the procurement and deployment of PPE and catalytic investment for effective roll out of COVID-19 tools. The role of HSC is rather to identify critical needs and serve as a common link with existing technical and financial country partners and platforms, such as multilateral agencies, bilateral donors, multilateral development banks including the World Bank’s MPA, UHC2030, etc. The adequate resourcing of these health system enablers — from domestic and external sources — is critical and will require significant additional investments that are complementary to, but currently outside the scope of ACT-Accelerator.”

No mention of IP issues with respect to expanding manufacturing. [This is not surprising, but important to underscore.]

“Expand manufacturing
Scaling up production, in particular for vaccines and diagnostics, is one of the key bottlenecks to address. By improving regionalized manufacturing and technology transfers, and reducing complexities (e.g. harmonized regulatory standards, indemnification and liability, compensation for adverse events, labelling and procurement mechanisms), ACT-Accelerator aims to expand manufacturing for increased coverage of tests, treatments and vaccines.”

[See our earlier story on ACT A plans to raise funds: The ACT-A Agenda: The financialization of a pandemic?]

*Image credit: Photo by* ***Thirdman*** *from* ***Pexels***

II. WHAT WE FOUND INTERESTING

NEWS:

As vaccine nationalism deepens, governments pay to bring production home: Reuters

Trade and economic concerns unleashed by the pandemic, is sure to bring in structural changes in supply chains.

“Unlike the United States, where the government’s Operation Warp Speed began funding the expansion and retrofit of pharmaceutical manufacturing sites early in the pandemic, few countries globally have the option to commandeer factories. The German plan is one of more than half a dozen by governments around the world to avert shortages by supporting drug companies’ local production.”

Is COVAX part of the problem or the solution? Devex

A well-rounded story with lots of voices, but somehow makes a surprising, unstated deduction that the COVAX Facility is here to stay.
To Democratize Vaccine Access, Democratize Production: Foreign Policy
As the tech transfer discussion heats up, this is recommended reading.

“Sharing patents is necessary but not sufficient. To expand production within six months, companies need to be incentivized to share know-how and technology. This is common practice among companies already. There is even a whole subindustry dedicated to conducting tech transfers by helping pharmaceutical companies teach contractors how to source materials, set up production lines, and ensure quality without burdening limited human resources in originator companies.”

Bombshell analysis traces new Ebola outbreak to survivor of West Africa crisis: Stat News

Even as the world’s attention is scattered on COVID-19, a senior journalist brings to our notice the evolving Ebola story.

“A survivor of the massive 2014–2016 West African Ebola outbreak almost certainly triggered an outbreak currently underway in Guinea, according to a new genetic analysis, news that has landed like a bombshell in the community of researchers who study the dangerous virus.
The analysis suggests that a survivor of the historic Ebola outbreak continued harboring the virus at least five years after being infected, eventually transmitting it to someone. Previously, the longest an Ebola survivor was believed to have shed the virus was about 500 days.”

WTO DG’s “third way” to fight COVID-19 a tough sell: Third World Network

An article that traces the history of discussions around technology transfer.

“The six-decade-long deliberations on the issue of technology transfer show that technology licensing has been one of those issues that has continuously reinforced the North-South divide.”

Big Tobacco’s Strategic Ally Interferes in WHO Alcohol Policy Consultation: Movendi International

The growing power of transnational lobbies in attempting to influence global health policy.

“In December 2020 the World Health Organization conducted a web-based consultation on a working document to develop a global action plan to better implement the WHO Global Alcohol Strategy. When the submissions were released recently a concerted effort of the alcohol industry became apparent: deploying the Big Tobacco strategy and network where think tanks interfere on behalf of the industries in public health policy making. This mobilization of Big Tobacco’s network to undermine alcohol policy development at the WHO calls into question even more why the alcohol industry is allowed to participate in the first place.”

India’s Smart Vaccine Diplomacy: Project Syndicate

Post card from South Asia on the growing vaccine diplomacy by India, the compulsions and the motivations.

“There is also an unspoken subtext: rivalry with China, with which tensions have intensified following clashes along the Himalayan frontier. Not only has India overshadowed China as a provider of cheap and accessible vaccines to the Global South; it has been quicker and more effective. For example, China has announced 300,000 doses for Myanmar but is yet to deliver any, while India quickly supplied 1.7 million. Similarly, Indian vaccines beat China’s into Cambodia and Afghanistan.”

Canada based Biolyse Pharma Seeks to Manufacture COVID-19 Vaccines for Low-Income Countries, may test Canada’s compulsory licensing for export law: Knowledge Ecology International

This has obviously made CL-watchers very excited. [CL: Compulsory Licensing]

“These requirements and Biolyse’s attempts have shown that the compulsory license application process under CAMR is complicated and challenging. Biolyse’s effort to obtain a compulsory license will test the actual intentions of the Canadian Government to scale-up production of COVID-19 vaccines and to permit export of pharmaceutical products under a compulsory license to developing or least-developed countries to address unmet needs.”

(While on the subject, see this South Centre resource: Compulsory Licenses And Government Use Of Patented Medicines: Precedents Relevant To Address Covid-19)

FROM THE JOURNALS / REPORTS:

Market strategies used by processed food manufacturers to increase and consolidate their power: a systematic review and document analysis: Wood, B., Williams, O., Nagarajan, V. et al. Global Health 17, 17 (2021).

WHO’s vaccines safety committee meeting: March 16
EMA’s safety committee (PRAC) will hold an extraordinary meeting on the AZ vaccine on Thursday, 18 March
WHO: Member States virtual briefing on a proposal for international treaty for pandemic preparedness and response, 18 March
Member States Virtual Informal Consultation on Strengthening WHO Preparedness for and Response to Health Emergencies (organized by the European Union), 18 March
Webinar Watch: No Business As Usual: Challenging The IP Protection Framework Now And After Covid-19: Organized by Health Action International, 17 March