Novavax and Serum Institute of India Pvt. Ltd. (SII), announce a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax' protein-based COVID-19 vaccine candidate with Matrix-M adjuvant.
If authorized, the vaccine (known as NVX-CoV2373) will be manufactured and commercialized by SII in South Africa under the brand name Covovax.
The submission includes data from two Phase 3 clinical trials in U.S. and Mexico; and a trial in U.K. In both trials, the vaccine demonstrated high efficacy with a reassuring safety profile.
Novavax' vaccine has received authorizations in over 170 countries, including conditional marketing authorization in the European Union and emergency use listing (EUL) from the WHO.
The company expects to submit a request for EUA for the vaccine in U.S. after one month in accordance with FDA guidance regarding submission of all EUA vaccines.