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Pune-based Serum Institute of India and US-based Novavax have announced an agreement for the development and commercialization of Novavax’ COVID‑19 vaccine candidate in India and other low- and middle-income countries. The agreement is expected to support minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries, Novavax said.

“We believe that Novavax’ NVX-CoV2373 has significant potential to successfully prevent COVID-19. Given our experience with Novavax on the development of a malaria vaccine, we know the power of their vaccine technologies,” said Adar Poonawalla, Chief Executive Officer of Serum Institute of India. “We will work urgently together to bring this vaccine to patients in these geographies.”

This agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights.

Stanley C. Erck, President and Chief Executive Officer of Novavax, said: “As the world’s largest vaccine manufacturer in terms of doses delivered, Serum Institute is the ideal partner to advance NVX‑CoV2373 throughout India and the low- and middle-income countries. This partnership continues to build on our companies’ collaborative history.”

Earlier this month, Novavax had reported that its vaccine candidate was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase I and Phase II trials.

According to the agreement, for low- and middle-income countries, Novavax and Serum Institute are partnering on clinical development, co-formulation, filling and finishing and commercialization of Novavax’s covid vaccine. Serum Institute will be responsible for regulatory submissions and marketing authorizations. Novavax will provide to Serum Institute both vaccine antigen and Matrix‑M adjuvant.

The companies are in discussions to have Serum Institute manufacture vaccine antigen in India. Novavax and Serum Institute will split the revenue from the sale of product, net of agreed costs.

Serum Institute has also partnered with Oxford University-Astra Zeneca for manufacturing covid vaccine in India. Recently, the Drugs Controller General of India (DCGI) has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD) in India.

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