Gaithersburg-based Novavax (Nasdaq: NVAX) continues Emergency Use Authorization (EUA) filings around the world. This time, the company is using its EUA filings in South Africa with its partner Serum Institute of India, the world's largest vaccine manufacturer measured by volume. Novavax said it is on the verge of filing an EUA with the Food and Drug Administration (FDA) in Silver Spring.
Last month, it submitted the final package required to move forward. If approved, the biotech would be able to distribute its protein-based COVID-19 vaccine in the United States as early as this month.
The regulatory documents were submitted to the South African Health Products Regulatory Agency (SAHPRA). South Africa is also ground zero for the Omicron variant of COVID-19 where the first case was first reported.
"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."
Novavax said it has already received authorizations of the vaccine in over 170 countries, including European Union and emergency use listing (EUL) from the World Health Organization (WHO), India, Indonesia, and the Philippines.