Novavax submits final data packages to FDA for COVID-19 vaccine EUA

Novavax (Nasdaq: NVAX) closed down 7.6% at $143.07 on Friday, despite announcing that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the US Food and Drug Administration for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.

Novavax expects to submit a request for EUA for the vaccine in the USA in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.

“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” said Stanley Erck, president and chief executive of Novavax. “