WHO, Member States Should Resist G20 Politicization of WHO Emergency Use Listing [EUL] “Procedures and Processes”


3 November 2021
By David R Curry
Executive Director, Center for Vaccine Ethics & Policy; President & CEO, GE2P2 Global Foundation

Of course, I immediately read through G20 Rome Leaders’ Declaration released on Sunday, 31 October – hoping, I suppose, for new, breakthrough commitments on COVID-19 vaccine dose sharing and a real action plan on deliver on commitments already made.

No such commitments or action plans were evident beyond “we shall strive…” diplo-speak.

But my disappointment was quickly overtaken by alarm in seeing language in the Declaration signaling that G20 leaders would seek to “optimize” [we read ‘politicize’] WHO Emergency Use Listing procedures and processes [bolded text below].

[Excerpt from G20 Rome Leader’s Declaration, paragraph 5]
“…We will work together towards the recognition of COVID-19 vaccines deemed safe and efficacious by the WHO and in accordance with national legislation and circumstances, and to strengthen the organization’s ability regarding approval of vaccines, including optimizing procedures and processes, with the aim of broadening the list of vaccines authorized for emergency use (EUL), while continuing to protect public health and ensuring privacy and data protection…”

This “optimization” language did not appear on the joint communique issued by the G20 Finance-Health Ministers just two days before. And it certainly was not requested in the WHO Director General’s short speech to the G20 leaders making five simple requests just the day before.

So what, exactly, needs “optimization”?

WHO has approved Emergency Use Listing [EUL] for seven COVID vaccines to date and continues to transparently report on the status of all 23 vaccines that are active in the EUL review process:

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 20 October 2021 [For 23 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date]

What is clear is from this scorecard is that a number of vaccine-specific EUL review processes as above have stalled – not because WHO is stalling, but because the vaccine developer [some with country government sponsorship] has not produced the required documentation or clinical trial data, or are not able to meet manufacturing and quality review standards.

Let’s be clear: these WHO EUL “procedures and processes” have not been suddenly invented for the pandemic, or designed to somehow constrain pandemic response. They are:

“…a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data. The procedure is a key tool for companies wishing to submit their products for use during health emergencies.”

In our view, WHO EUL procedures and processes have been serving the global community well.

Of course, the global community depends on – and should be able to confidently depend on – independent, science-based WHO review and approval processes for EUL, as well as for pre-qualification and for development of independent, expert analysis and recommendations leading to WHO guidance [SAGE, for example, for vaccines]. These processes support country regulatory decisions on medicines, medical devices and vaccines literally every day, globally.

Equally, it must be recognized that perhaps too many countries are proceeding to approve “questionable” vaccines outside WHO approval processes or the approval of any Stringent Regulatory Authority [SRA]. This country approval activity – while certainly within the sovereign right of member states — is somewhere between disappointing and dangerous.

Further, and also disappointing, too many countries are concluding bilateral deals purchasing such “questionable” vaccines. UNICEF is regularly reporting on sourcing agreement here:

UNICEF COVID-19 Vaccine Market Dashboard :: Agreements Table [An overview of information collected from publicly announced bilateral and multilateral supply agreements]

So, clearly, we are not in an ideal place at the moment regarding harmonized global and country health governance around COVID vaccines approvals and sourcing. This situation is also compounding challenges involving vaccine nationalism, IP/TRIPS, dose sharing, and equity [which the G20 could have more forcefully addressed in Rome].

But the G20 making noises about “optimizing” EUL procedure and processes is clearly not helpful.

Indeed, the specific language in the Declaration draws a causal link between “optimizing” EUL procedures and “broadening the list of vaccines authorized for emergency use [EUL].” In fact, there is no such causal [or logical] link and the opposite might well obtain.

If anything, G20 leaders should be calling WHO to hold firm to its independence, its science-based standards, and the review and approval processes and procedures that are among its primary strengths and, indeed, part of its core mandate.

Finally, if “optimization” of WHO EUL processes is, in fact, indicated, it is a matter for member states to pursue, vigorously and jointly, through mechanisms including the full World Health Assembly. Member states of the G20 do not, and should not, enjoy any special standing in this regard, and rhetoric that suggests they do is both disappointing and dangerous.

So from whatever quarter it might emerge – and certainly if it emerges from countries whose domestic developers have COVID vaccine candidates already in EUL review – pressure to “optimize” or otherwise compromise the integrity of WHO EUL processes should be resisted and publicly dismissed. In short, we urge WHO to hold fast!!

                                                     #                       #                    #                      #


G20 Rome Leaders’ Declaration
31 October 2021 :: 20 pages
[Excerpt on COVID Vaccines; Editor’s text bolding, paragraph formatting for readability]
4. Health.
Recognizing that vaccines are among the most important tools against the pandemic, and reaffirming that extensive COVID-19 immunization is a global public good, we will advance our efforts to ensure timely, equitable and universal access to safe, affordable, quality and effective vaccines, therapeutics and diagnostics, with particular regard to the needs of low- and middle-income countries.

To help advance toward the global goals of vaccinating at least 40 percent of the population in all countries by the end of 2021 and 70 percent by mid-2022, as recommended by the World Health Organization (WHO)’s global vaccination strategy, we will take steps to help boost the supply of vaccines and essential medical products and inputs in developing countries and remove relevant supply and financing constraints. We ask our Health Ministers to monitor progress toward this end and to explore ways to accelerate global vaccination as necessary.

5. We will reinforce global strategies to support research and development as well as to ensure their production and swift and equitable distribution worldwide, also by strengthening supply chains and by expanding and diversifying global vaccine manufacturing capacity at local and regional level, while promoting vaccine acceptance, confidence and fighting disinformation.

To this end, we commit to refrain from WTO inconsistent export restrictions and to increase transparency and predictability in the delivery of vaccines. We reiterate our support to all pillars of the ACT-Accelerator, including COVAX, and will continue to improve its effectiveness. We support the extension of ACT-A’s mandate throughout 2022 and acknowledge the formation of the Multilateral Leaders Task Force on COVID-19. We welcome the work undertaken by the COVAX ACT-A Facilitation Council Vaccine Manufacturing Working Group and its report aimed at creating a broader base for vaccine manufacturing.

In particular, we will support increasing vaccine distribution, administration and local manufacturing capacity in LMICs, including through technology transfer hubs in various regions, such as the newly established mRNA Hubs in South Africa, Brazil and Argentina, and through joint production and processing arrangements.

We will work together towards the recognition of COVID-19 vaccines deemed safe and efficacious by the WHO and in accordance with national legislation and circumstances, and to strengthen the organization’s ability regarding approval of vaccines, including optimizing procedures and processes, with the aim of broadening the list of vaccines authorized for emergency use (EUL), while continuing to protect public health and ensuring privacy and data protection.

As a collective G20 effort, and in light of the enduring vaccination gaps, we commit to substantially increase the provision of and access to vaccines, as well as to therapeutics and diagnostics. We will enhance our efforts to ensure the transparent, rapid and predictable delivery and uptake of vaccines where they are needed.

We call on the private sector and on multilateral financial institutions to contribute to this endeavor. We acknowledge the work of the World Bank Group in this respect and of the IMF and the WHO through the vaccine supply forecast dashboard…