Novavax, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, have amended its existing agreement with Serum Institute of India Private Limited under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate. Under the agreement, Novavax increases 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 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.
"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 Erck, president and CEO of Novavax. "We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks."
The agreement with SIIPL augments a global supply chain that will deliver more than 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 partnered manufacturing sites of 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 and Takeda Pharmaceutical Company Limited in Japan.
Novavax’ Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and at AGC Biologics in the United States and Denmark. PolyPeptide Group will manufacture two intermediaries used in Matrix-M in the United States and Sweden.
Read the Novavax release