Novavax said the agreement will allow for the development and distribution of NVX‑CoV2373, a recombinant vaccine engineered from the genetic sequence of SARS-CoV-2, in India and in low- and middle-income countries.
Days after Novavax, Inc. announced its experimental COVID-19 vaccine candidate produced antibodies in healthy patients in a clinical study, the company announced a license agreement with Serum Institute of India Private Limited (SIPL) to develop up to 1 billion doses of the preventative drug in India and other countries.
Gaithersburg, Maryland-based Novavax said the agreement will allow for the development and distribution of NVX‑CoV2373, a recombinant vaccine engineered from the genetic sequence of SARS-CoV-2, in India and in low- and middle-income countries. Those additional countries were not identified in the announcement. Novavax retains the rights to develop its vaccine candidate in upper-middle and high-income countries, the company said. The deal is expected to support the manufacturing of a minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries.
According to the Johns Hopkins University COVID-19 dashboard, India has more than 2 million COVID-19 cases, the third-worst global outbreak in terms of total numbers of reported infections. India has reported more than 41,500 COVID-19 related deaths since the outbreak began earlier this year.
Under terms of the agreement, SIPL will be responsible for regulatory submissions and marketing authorizations in India and the countries it intends to distribute the vaccine. Novavax will provide SIPL with the vaccine antigen and its proprietary Matrix‑M adjuvant. Novavax and SIIPL are in discussions to have SIIPL manufacture vaccine antigen in India.
Stanley C. Erck, president and chief executive officer of Novavax, said the company is committed to ensuring there is a global supply for its COVID-19 vaccine. Erck said he hopes this deal will benefit COVID patients in low-income countries that have been significantly impacted by the pandemic.
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 LMIC countries. This partnership continues to build on our companies’ collaborative history,” Erck said in a statement.
SIPL CEO Adar Poonawalla said he believes 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. We will work urgently together to bring this vaccine to patients in these geographies,” Poonawalla said in a statement.
This agreement complements Novavax’s collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). Through that partnership with CEPI, Novavax committed to develop and manufacture significant amounts of NVX-CoV2373, and, if it proves to be effective, to distribute it equitably through a globally fair allocation framework.
In July, Novavax secured $1.6 billion in U.S. federal funding to support its COVID-19 vaccine development program. The funding came from Operation Warp Speed, the U.S. efforts to quickly develop a vaccine against COVID-19 and provide hundreds of millions of doses to people across the nation. For Novavax, that funding will support late-stage development of its vaccine candidate and will be used to establish large-scale manufacturing in order to deliver 100 million doses of NVX‑CoV2373 by the end of the year.
