Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced 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 U.S. Food and Drug Administration (FDA) 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 U.S. 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 C. Erck, President and Chief Executive Officer, Novavax. “We thank the U.S. Government for its ongoing support of our COVID-19 vaccine program, as well as our clinical trial participants and those who have supported the development and manufacturing of our vaccine.”

Novavax has filed the complete CMC data package, which leverages Novavax’ manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, with the FDA. The company expects to later supplement the submission with data from additional manufacturing sites across Novavax’ global supply chain.