Novavax announced COVID-19 vaccine manufacturing agreement with Serum Institute of India

, , , ,

On Sept. 15, 2020, Novavax announced an amendment to its existing agreement with Serum Institute of India which manufactured the antigen component of NVX-CoV2373, Novavax COVID-19 vaccine candidate. Novavax increased its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX-CoV2373 was a stable, prefusion protein made using Novavax recombinant protein nanoparticle technology and includes Novavax proprietary Matrix-M adjuvant.

The agreement with SIIPL augments a global supply chain that will deliver over two billion doses of NVX-CoV2373 annually as of 2021. 

The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites:

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

Novavax’ Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and the following partnered manufacturing sites:

  • AGC Biologics in the United States and Denmark
  • PolyPeptide Group will manufacture two key intermediaries used in Matrix-M in the United States and Sweden

NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

Tags:


Source: Novavax
Credit: