Novavax and Serum file EUA for Covovax in South Africa

Novavax' vaccine has received authorizations of the vaccine in over 170 countries

Novavax and Serum Institute of India (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.

"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. "Novavax and Serum Institute remain 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."

In total, Novavax' vaccine has received authorizations of the vaccine in over 170 countries, including conditional marketing authorization for its vaccine in the European Union and emergency use listing (EUL) from the World Health Organisation (WHO). The Novavax/SII vaccine (Covovax) recently received EUA in India, Indonesia and the Philippines.  EUL 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. Food and Drug Administration (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.