Novavax receives first authorization for its COVID-19 vaccine

With storage temperatures of 2° to 8° Celsius, Novavax says the protein-based vaccine could potentially help increase access in hard-to-reach areas.

The two-dose vaccine, NVX-CoV2373, is engineered from the genetic sequence of the first strain of SARS-CoV-2: using Novavax's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with its saponin-based Matrix-M adjuvant.

Phase 3 trials have reported vaccine efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.

For the Indonesian market, the vaccine will be manufactured and marketed by Serum Institute of India. It will be produced in India and marketed in Indonesia under the brand name Covavax. Initial shipments are due to begin imminently.

"The first authorization of Novavax' COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population,"​ said Stanley C. Erck, President and Chief Executive Officer, Novavax.

"This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally."​

Novavax and Serum Institute have already filed for authorization of the vaccine in India and the Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organization.

Novavax also recently completed rolling submissions for authorization of the vaccine with regulatory agencies in the UK, EU, Canada and Australia; and plans to submit its complete package to the US Food and Drug Administration (FDA) by the end of the year.