Maryland-based Novavax, Inc., announced today that it has completed the submission of the final data package, including the complete Chemistry, Manufacturing and Controls (CMC) module, to fulfill the prerequisites for the Emergency Use Authorization (EUA) application from the US Food and Drug Administration (FDA) for NVX-CoV2373.
NVX-CoV2372 (Nuvaxovid, Covovax) is a COVID-19 vaccine based on recombinant protein nanoparticles with Matrix-M ™ adjuvant.
Novavax plans to submit an EUA application for the vaccine in the United States within one month in accordance with the FDA guidelines for submitting all EUA vaccines.
Novavax has filed the full CMC data dossier, which takes advantage of Novavax’s manufacturing partnership with the Serum Institute of India Pvt. Ltd.
The company plans to complete the submission at a later date with data from additional manufacturing sites in Novavax’s global supply chain.
As of December 31, 2021, the European Commission, Indonesia and the Philippines had issued authorizations. And the company has confirmed that it has submitted regulatory applications for its vaccine to UK, Australia, New Zealand, Canada, EU, India, Singapore, South Korea, UAE. and in Japan.
And, the World Health Organization granted a second emergency use list for NVX-CoV2373 on December 20, 2021.
“Novavax is committed to delivering our protein-based vaccine to the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, the continued need to ensure primary immunization of the eligible population and the need for a recall, “said Stanley C. Erck, President and CEO of Novavax, in a press release issued on December 31, 2021.
“We thank the United States government for its continued support of our COVID-19 vaccination program, as well as our clinical trial participants and those who have supported the development and manufacture of our vaccine. “
Novavax recently announced that a two-dose primary regimen of NVX-CoV2373 demonstrated cross-immune responses against Omicron (B.1.1.529) and other variants.
The PREVENT-19 Phase 3 clinical trial is being conducted with support from the U.S. government, which is providing up to $ 1.75 billion under a Department of Defense agreement.
NVX-CoV2372 was designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause COVID-19.