Novavax Increases Global Mfg Capacity for COVID-19 VaccineBy
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has amended a previous agreement with the Serum Institute of India (SII), a Pune, Maharashtra, India-based vaccine manufacturer, under which SII will produce the antigen component of Novavax’s COVID‑19 vaccine candidate, NVX‑CoV2373. With the new agreement, Novavax increases its manufacturing capacity of the vaccine to more than two billion doses annually when all planned capacity has been brought on line by mid-2021.
NVX‑CoV2373 is a stable, prefusion protein made using Novavax’s recombinant protein nanoparticle technology and includes Novavax’s proprietary saponin-based adjuvant, Matrix‑M. Last month (August 2020), Novavax and SII announced a partnership for the co-formulation and fill–finish of the vaccine for low- and middle-income countries and India and announced that they were in discussions for antigen production.
Including the new pact with SII for antigen production, the antigen component of NVX-CoV2373 is being manufactured by Novavax at its site in Bohumil, Czech Republic as well as at the following partnered manufacturing sites: (1) Spain by Biofabri, a biopharmaceutical company; (2) North Carolina, Texas, and the UK by Fujifilm Diosynth Biotechnologies, a biologics CDMO; (3) India, SII; (4) Republic of Korea, SK Bioscience, a vaccine developer and manufacturer and part of the SK Group and (5) Japan, Takeda Pharmaceutical.
Novavax’s Matrix-M adjuvant is now being manufactured by Novavax at its facilities in Uppsala, Sweden and the following partnered manufacturing sites: (1) the US and Denmark by AGC Biologics, a biologics CDMO, and (2) the US and Sweden of two key intermediates by PolyPeptide, a contract peptides manufacturer.