Serum Institute to manufacture 200mn doses of Covid-19 vaccine

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 collaboration further bolsters our fight against Covid-19. Through the avid support of Gavi and the Bill & Melinda Gates Foundation, we will now manufacture and deliver up to an additional 100 million doses of immunogenic and safe-proven future Covid-19 vaccines to India and low- and middle-income countries in 2021," said Adar Poonawalla, CEO of Serum Institute of India.

He added, "At this stage, it is important for governments, global health and financial institutions in the public and private sector to come together in ensuring that no one is left behind in the road to recovery. This association is in line with our efforts to see that the future vaccines reach the remotest part of the world providing full immunization coverage in a bid to contain the spread of the pandemic."

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 US$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. "This is vaccine manufacturing for the Global South, by the Global South, helping us to ensure no country is left behind when it comes to access to a Covid-19 vaccine," said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance.

"The momentum behind our effort to ensure global, equitable access to Covid-19 vaccines is really building. Last week, we were able to announce the historic number of countries that are now signed up to the COVAX Facility, today we can announce further doses of safe, effective vaccines that will be reserved specifically for low- and middle-income countries. No country, rich or poor, should be left at the back of the queue when it comes to Covid-19 vaccines; this collaboration brings us another step closer to achieving this goal."

The Gavi COVAX AMC, which is currently seeking at least US$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. The collaboration between Gavi, SII, and the Gates Foundation supports the efforts of the ACT Accelerator's vaccines pillar, also known as COVAX, co-led by Gavi, CEPI and the World Health Organization (WHO), to accelerate the development of COVID-19 vaccines and ensure rapid, global access to them.

Decisions around investment in manufacturing are taken in close collaboration between these three lead organisations of the COVAX pillar. 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.

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. The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, will provide at-risk funding of a further US$150 million to Gavi, bringing the total funding provided through this collaboration to US$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 a Memorandum of Understanding 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. These two deals can help assure access to early doses for the most vulnerable on a truly global scale.