Novavax has contracted India’s Serum Institute to make more than a billion doses of its protein-based COVID-19 vaccine candidate, pushing total capacity to 2 billion doses across its network.
NVX-CoV2373 is a potential vaccine against the COVID-19 consisting of a prefusion protein made using Novavax’ nanoparticle technology based on infecting Sf9 insect cells with baculovirus viral vectors that express the SARS-CoV-2 spike protein. The vaccine is also being tested with Novavax’ Matrix M adjuvant, a saponin-based adjuvant that acts in part by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the local lymph nodes.
As the candidate moves towards Phase III trials, Novavax has secured a number of deals with third-party manufacturers to ensure large-scale production in the case of approval, the latest with the Serum Institute of India, “the largest by volume vaccine company in the world,” according to Novavax CEO Stanley Erck.
Image: iStock/Kunal Mahto
Speaking at the Cantor Global Healthcare Conference this week, he told investors the partnership is part of a strategy to ensure capacity of over 2 billion doses of NVX-CoV2373 from next year by distributing “over a billion doses annually to all of the low and middle income countries of the world. We can’t do that.”
He added Serum joins a network of NVX-CoV2373 makers “already established in Europe, in United States and in Asia [so] we are prepared next year to be able to produce at a level of an excess of 2 billion doses of our vaccines”
In July, the firm teamed with contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies to produce the drug substance from its site in Morrisville, North Carolina, as well as from sites in Texas and the UK.
Other third-parties on the books include Biofabri in Spain, SK Bioscience in the Republic of Korea, Takeda in Japan, AGC Biologics in the US and Denmark, and PolyPeptide Group in the United States and Sweden.
Meanwhile, Novavax is utilizing its own network with its site in Bohumil, Czech Republic making the antigen component of the candidate and its site in Uppsala, Sweden making the Matrix-M adjuvant.