Novavax, Serum Institute file for emergency use authorisation of Novavax' COVID-19 vaccine in South Africa
Jan 10, 2022
Gaithersburg [US], January 10 : Novavax, a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India (SII), on Monday, 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 authorised, the vaccine (known as NVX-CoV2373) will be manufactured by and commercialized by SII in South Africa under the brand name Covovax," said Novavax in a statement on Monday.
"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 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.
In total, Novavax's vaccine has received authorizations of the vaccine in over 170 countries, including conditional marketing authorisation for its vaccine in the European Union 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 US Food and Drug Administration (FDA) at the end of 2021.
The company expects to submit a request for EUA for the vaccine in the US after one month in accordance with guidance from the FDA regarding the submission of all EUA vaccines.
