Serum Institute to produce up to additional 100 mn COVID-19 vaccine doses for India and LMIC in 2021

Serum Institute of India (SII), Gavi and the Bill & Melinda Gates Foundation will accelerate the manufacture and delivery of up to 100 million doses of safe and effective COVID-19 vaccines for India and low-and middle-income countries (LMICs) as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility.

This brings the total number of vaccine doses to be covered by the partnership between SII, Gavi, and the Gates Foundation to an aggregate of up to 200 million doses, following the initial agreement for up to 100 million doses announced in August. The arrangement again provides an option to secure additional doses if the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator sees a need for it.

The collaboration will provide upfront capital to SII to help it increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO Prequalification, doses can be distributed at scale to LMICs as part of the Gavi COVAX AMC mechanism as early as the first half of 2021.

The funding will help accelerate the manufacturing by SII for candidate vaccines licensed from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification. The vaccines will have a ceiling price of $3 per dose, a price enabled by investments made by partners such as the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill and Melinda Gates Foundation and SII.

The Gavi COVAX AMC, which is currently seeking at least $2 billion in initial seed funding, will meet at least part of the cost of procurement for the vaccine doses. The Gavi Board has agreed upon the final list of 92 countries that will be supported by the Gavi COVAX AMC. Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 61 Gavi-eligible countries. Novavax’s candidate, if successful, will be available to all 92 countries supported by the Gavi COVAX AMC. These countries align with SII’s licensing agreements with the two partners.

So far 73 higher-income economies have formally committed to join the facility, in addition to the 92 low-and middle-income economies that are eligible for support from the Gavi COVAX AMC.

Under the COVAX umbrella, Gavi is coordinating the COVAX Facility, which provides governments with the opportunity to benefit from a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by more manufacturers across the world, with a bigger market to provide security of demand.

The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, will provide at-risk funding of a further $150 million to Gavi, bringing the total funding provided through this collaboration to $300 million. This will be used to support the Serum Institute of India to manufacture potential vaccine candidates, and for future procurement of vaccines for India and low-and middle-income countries via Gavi’s COVAX AMC.

The deal is additional to an MoU between AstraZeneca and Gavi, announced in June, which will commit an additional 300 million doses of AstraZeneca’s candidate vaccine to the wider COVAX Facility, to be supplied upon licensure or prequalification.