COVID-19 Vaccines: World Bank Country Financing/Oversight

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COVID-19 Vaccines: World Bank Country Financing/Oversight

 

Editor’s Note:
In our edition of 17 October 2020, we reported on a World Bank Group [WBG] announcement of a USD$12 billion “envelope for developing countries to finance the purchase and distribution of COVID-19 vaccines, tests, and treatments for their citizens.”

In a supporting document – WBG VACCINE ANNOUNCEMENT– KEY FACTSthe World Band noted that it “will help client countries develop appropriate criteria for making the selected vaccine available to all their citizens.” This document references a “consensus to first target health workers, other essential workers, and priority groups such as the elderly, people with co-morbidities, and others at high risk from COVID-19” and added that “the Bank will ensure that the allocation mechanisms within countries are fair and equitable.”

Given the number of active COVID-19 vaccine allocation frameworks and guidance documents, the role of multilateral collaborations such as COVAX, and varying regulatory and recommending bodies, we found this stated role ensuring that allocation is fair and equitable to be quite interesting.

 

The Center for Vaccine Ethics and Policy [CVEP] raised five questions about this oversight role with the World Bank. The questions and the WBG answers are presented below:

[1] [CVEP] Will WBG be using any specific “active” normative guidance [WHO Values Framework; COVAX allocation framework, NSAEM Framework, country-level allocation strategies, etc.] to define/guide what ” fair and equitable” will mean in a country’s allocation mechanisms? If not, will WBG create its own guidance?
[WBG] Country allocation strategies will be appraised for their alignment with the WHO Fair Allocation Framework before Bank financing for vaccine purchase will be committed.
 
[2] [CVEP] Would the vaccine allocation “formula/strategy” be specified in the financing terms of the World Bank “grants, credits, and loans” that might be employed in any given country situation?
[WBG] There is no predetermined allocation of financing to countries.   Countries will decide the amounts within their IBRD/IDA allocations, and will access the financing on their applicable country specific IDA or IBRD financing terms.
[International Bank for Reconstruction and Development/International Development Association]

[3] [CVEP] What WBG governance/review mechanism will be employed to assess/confirm that the allocation approach proposed by the country is, indeed, fair and equitable? What monitoring mechanism will ensure that the allocation plan is executed adequately in that regard?
[WBG] The Bank will appraise the client’s overall vaccination strategy, including its specific allocation approach, before committing financing for vaccine purchases. The appraisal of the allocation framework will consider alignment with the WHO Fair Allocation Framework as well compliance with Bank risk management frameworks and policies as applicable, such as the Environmental and Social Framework. Bank teams will supervise implementation of the project and provide implementation support to the client as in any Bank-financed operation, including to monitor compliance with the agreed allocation plan.

[4] [CVEP] Does WBG intend to take a position on COVID-19 vaccine program elements beyond “fairness and equitable access”? Such elements would include requirements for a consent process [at least where a vaccine is still investigational [EUA without Phase III data/not yet licensed by any major reg authority]], ad mandates [where a government may require immunization with a vaccine which still may be EUA, for example]?
[WBG] Given the unprecedented pace of vaccine development, the Bank will accept as the threshold for eligibility of IBRD/IDA resources for vaccine purchase either (i) approval by Stringent Regulatory Authorities (SRAs) in three regions or (ii) WHO prequalification and approval by 1 SRA*.

[5] [CVEP] Does the WBG program anticipate that multiple COVID-19 vaccines — with varying profiles [EUA vs major reg approval; safety; efficacy; durability of protection; etc.] — will be in play in the same country at the same time, with varying constellations over time? This complexity suggests a very dynamic allocation scenario that will change, perhaps continuously, over 2+ years at least…
[WBG] We are working in complexity and a high degree of uncertainty and have developed the programmatic framework with the best available information.  As the vaccine landscape continues to develop we take a dynamic view in supporting countries to ensure their programs are  adapted to help maximize impact for their populations.

*List of Stringent Regulatory Authorities (SRAs) [WHO]
…The interim definition of an SRA includes the same elements as the current definition, each qualified by the wording “as before 23 October 2015”, as follows:
“A regulatory authority which is:
[a] a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or
[b] an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or
[c] a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).”
Currently there are 35 country NRAs [National Regulatory Authorities]which are designated as SRAs: Australia Austria Belgium Bulgaria Canada Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Japan Latvia Liechtenstein
Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia
Slovenia Spain Sweden Switzerland United Kingdom United States of America