Novavax, SII File COVID Vax EUA in South Africa

Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. If authorized, the vaccine will be manufactured by and commercialized by SII in South Africa under the brand name Covovax.
 
The submission includes data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico; and a trial with almost 15,000 participants in the UK. In both trials, the vaccine demonstrated high efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
 
In total, Novavax’ vaccine has received authorizations of the vaccine in over 170 countries, including conditional marketing authorization in the EU and emergency use listing (EUL) from the World Health Organization (WHO). The Novavax/SII vaccine (Covovax) recently received EUA in India, Indonesia and the Philippines, as well as WHO EUL and is also currently under review by multiple regulatory agencies worldwide. This includes the submission of its complete chemistry, manufacturing and controls (CMC) data package to the U.S. FDA at the end of 2021. The company expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.