Geneva, 7 August 2020 – A new landmark collaboration between SII, the world’s largest vaccine manufacturer by volume, Gavi and the Bill & Melinda Gates Foundation will accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for low- and middle-income countries (LMICs) as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility.
The collaboration will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO Prequalification, doses can be produced at scale for distribution to LMIC countries as part of the Gavi COVAX AMC mechanism as early as the first half of 2021.
“Too many times we’ve seen the most vulnerable countries left at the back of the queue when it comes to new treatments, new diagnostics and new vaccines,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “With COVID-19 vaccines we want things to be different. If only the wealthiest countries in the world are protected, then international trade, commerce and society as a whole will continue to be hit hard as the pandemic continues to rage across the globe. This new collaboration is an important step in our efforts to prevent this from happening, helping to ensure we have additional manufacturing capacity to begin producing doses for every country, not just the wealthy few. We now need other vaccine manufacturers to step up and follow SII’s lead.”
The funding will help de-risk manufacturing by SII for candidate vaccines from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification. SII has set a ceiling price of US$ 3 per dose, a price enabled by investments made by partners such as CEPI and the Bill & Melinda Gates Foundation. The arrangement also provides an option to secure additional doses if the vaccines pillar of the ACT Accelerator sees a need for it.
"In an attempt to make our fight against COVID-19 stronger and all-embracing; SII has partnered with Gavi and the Bill & Melinda Gates Foundation to advance the manufacturing and delivery of up to 100 million doses of future COVID vaccines for low and middle income countries in 2021,” said Adar Poonawalla, CEO of Serum Institute of India. “The rampant spread of the virus has rendered the entire world in an unimaginable halt of uncertainty. And to ensure maximum immunization coverage and contain the pandemic, it is important to make sure that the most remote and poorest countries of the world have access to affordable cure and preventive measures. Through this association, we seek to ramp up our constant efforts to save the lives of millions of people from this dreadful disease.”
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. Last week the Gavi Board agreed upon the final list of 92 countries that will be supported by the AMC. Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 57 Gavi-eligible countries. Novavax’s candidate, if successful, will be available to all 92 countries supported by the AMC. These countries align with SII’s licensing agreements with the two partners.
This collaboration underscores India’s proven-track record in developing safe and quality vaccines. There is a long history of Gavi and pharmaceutical companies successfully partnering with Indian manufactures, particularly the Serum Institute of India, to manufacture vaccines that protect against meningitis, severe diarrhoea, pneumonia and measles.
"It is encouraging to see an Indian vaccine manufacturer, SII, work collaboratively with global partners with a view to making available affordable Covid-19 vaccine supplies for India and the world,” said Professor K VijayRaghavan, Principal Scientific Adviser to the Government of India. “Normally it would take more than a decade to develop such a vaccine but with the efforts of our researchers, academia and private sector, working closely with global collaborators we are hopeful of accelerating the availability of a successful vaccine, at reasonable cost and in sufficient quantities, to fight the pandemic."
“Researchers are making good progress on developing safe and effective vaccines for COVID-19,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. “But making sure everyone has access to them, as soon as possible, will require tremendous manufacturing capacity and a global distribution network. This collaboration gives the world some of both: the power of India’s manufacturing sector and Gavi’s supply chain. It’s just a start. Organizations like Gavi and CEPI need much more support to facilitate development and delivery of hundreds of millions - maybe billions - of vaccine doses by next year."
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, the Coalition for Epidemic Preparedness Innovations (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 leading 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 Facility, which is available to any country or economy, includes the AMC which specifically provides funding for vaccines for 92 low- and middle-income countries.
The COVAX pillar is working to accelerate R&D for promising vaccine candidates, manufacture doses at scale and deliver 2 billion doses globally by the end of 2021. CEPI, as a co-lead for the ACT Accelerator's Vaccines pillar, has agreements to support R&D for nine candidate vaccines, including the AstraZeneca and Novavax vaccine candidates.
The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, will provide at-risk funding of US$150 million to Gavi, which will be used to support the Serum Institute of India to manufacture potential vaccine candidates, and for future procurement of vaccines for 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 guarantee 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 guarantee access to early doses for the most vulnerable on a truly global scale.