Novavax submits final data to US FDA as prerequisite to EUA application request for COVID-19 vaccine

Novavax, Inc recently 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 Authorisation (EUA) application request to the US Food and Drug Administration (FDA) for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The company expects to submit a request for EUA for the vaccine in the US in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines, it notified.

Speaking in this regard, Stanley C Erck, President and Chief Executive Officer, Novavax, said, “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. We thank the US government for its ongoing support of our COVID-19 vaccine programme, 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’s manufacturing partnership with the Serum Institute of India (SII). The company expects to later supplement the submission with data from additional manufacturing sites across Novavax’s global supply chain, the statement further added.