New Collab Boosts Serum Institute of India’s COVID-19 Vaccine Production by 100 Million Doses

Vaccine Manufacturing_Compressed

The Serum Institute of India (SII) has agreed to produce and deliver up to an additional 100 million doses of an approved COVID-19 vaccine for citizens of India and neighboring low- and middle-income countries as part of a collaboration with Gavi and the Bill & Melinda Gates Foundation. This follows the initial August 2020 agreement which called for 100 million doses, bringing the total number of doses under the current partnership to an aggregate of 200 million.

The Bill & Melinda Gates’ Foundation’s Strategic Investment fund will offer at-risk funding of up to $150 million to Gavi and the Vaccine Alliance, resulting in up to $300 million in total funding for this vaccine initiative. Upfront capital will also be offered to the SII to help accelerate the institute’s manufacturing of COVID-19 vaccine candidates.

Under terms of the agreement and investments from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation, the vaccines produced by SII will have a cap of $3 per dose.

At least part of the costs of procurement for the COVID-19 vaccine doses will be met by $2 billion of initial seed funding, which the Gavi COVAX AMC is hoping to secure. A total of 92 countries will be supported by the Gavi COVAX AMC under the new collaboration. If successful, AstraZeneca’s candidate vaccine will be distributed to 61 eligible candidates, whereas Novavax’s COVID-19 vaccine candidate will be distributed to the 92 eligible countries backed by the Gavi COVAX AMC.

“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,” Gavi CEO Seth Berkley said in a statement. “The momentum behind our effort to ensure global, equitable access to COVID-19 vaccines is really building.”

The SII shows no chance of slowing down in the race toward providing a COVID-19 vaccine to the world population. The company has started manufacturing Codagenix's intranasal live-attenuated vaccine candidate, CDX-00, for SARS-CoV-2. Investors backing this collaboration include Adjuvant Capital and TopSpin Partners.

In early August, Novavax and the SII entered into a partnership supporting the development and commercialization of up to 1 billion doses of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373, through the COVAX Facility for low- and middle-income countries and India. The SII was able to gain exclusive rights to commercialize the vaccine in India under the agreement’s terms. News soon followed of an agreement between the two entities that increased the global manufacturing capacity for Novavax’s candidate to more than 2 billion annualized doses by mid-2021.

“With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents,” said President and CEO of Novavax, Stanley C. Erck. “We continue to work with extraordinary urgency to develop our vaccine, now in Phase II clinical trials, and for which we anticipate starting Phase III efficacy trials around the world in the coming weeks.”

The SII announced in late September it had selected leading global provider of services for biopharmaceutical manufacturing, ABEC, to support the manufacturing of Novavax’s COVID-19 vaccine. ABEC agreed to deliver six 4,000L CSR bioreactors, some the largest bioreactors in the industry, which the SII suggests will increase productivity per unit of floorspace and help achieve the lowest possible costs per vaccine dose.

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