Novavax Inc. (NASDAQ: NVAX), along with Serum Institute of India (SII), announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of its Covid-19 vaccine. If approved, the vaccine is set to be manufactured and commercialized by SII South Africa under the name Covavax.
“Novavax is thankful for our long-standing history of partnership in South Africa to advance much-needed vaccines. This is exemplified by the country’s vital role in the Phase 2b clinical trial and booster study of our protein-based Covid-19 vaccine” said Stanley C Erck, President, and Chief Executive Officer, Novavax.
The submission presents data from two critical Phase 3 clinical trials which had about 300,000 participants within the U.S. and Mexico. Furthermore, it was published by the New England Journal of Medicine (NEJM). Throughout both trials, the vaccine demonstrated high efficacy and an appropriate safety profile.
“Novavax and Serum Institute remains focused on delivering the Covid-19 vaccine – built on well-understood technology – where it is needed most. We look forward to SAHPRA’s review and, if authorized, delivering the vaccine to help South Africa control the pandemic,” Erck added.
Within the following month, Novavax hopes to submit a request for EUA for the vaccine within the U.S., compliant with guidance from the FDA in terms of the submission of all EUA vaccines.