Novavax in COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India

Published on: 

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

On Sept. 15, 2020 Novavax announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of Novavax’s COVID‑19 vaccine candidate, NVX‑CoV2373. With this amendment, Novavax will increases its manufacturing capacity for the vaccine candidate to more than two billion doses annually, when all planned capacity has been brought online by mid-2021.

The antigen component of the vaccine candidate is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), in addition to the following partnered manufacturing sites:

  • Biofabri in Spain
  • FUJIFILM Diosynth Biotechnologies (FDB), in the United Kingdom and in North Carolina and Texas in the United States (US)
  • SIIPL in India
  • SK Bioscience in the Republic of Korea
  • Takeda Pharmaceutical in Japan

Novavax’s Matrix-M adjuvant, a component of NVX‑CoV2373, is now being manufactured at Novavax AB in Uppsala, Sweden, and in the following partnered manufacturing sites:

  • AGC Biologics in the US and Denmark
  • PolyPeptide Group, which will manufacture two key intermediaries used in Matrix-M in the US and Sweden

“Signing of the manufacturing agreement with Novavax for NVX-CoV2373 is another great milestone for both companies, which will further strengthen our existing relationship. SIIPL expertise to scale-up and manufacture NVX-CoV2373 will help ensure the supply of this most-needed vaccine,” said Adar Poonawalla, CEO of Serum Institute of India, in a company press release.

“Today’s agreement with Serum Institute enhances Novavax’[s] commitment to equitable global delivery of our COVID-19 vaccine. 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 Stanley C. Erck, president and CEO of Novavax, in the press release. “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.”

Source: Novavax