Maryland's COVID-19 Vaccine Submits Final Data Packages to U.S. FDA
Maryland-based Novavax, Inc. today announced that it had completed the submission of the final data package, including the complete chemistry, manufacturing, and controls (CMC) module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the U.S. Food and Drug Administration (FDA) for NVX-CoV2373.
NVX-CoV2372 (Nuvaxovid, Covovax) is a 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 per guidance from the FDA regarding the submission of all EUA vaccines.
Novavax has filed the complete CMC data package, which leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd.
The Company expects to supplement the submission later with data from additional manufacturing sites across Novavax's global supply chain.
As of December 31, 2021, the European Commission, Indonesia, and The Philippines had issued authorizations. And the Company confirmed submitting regulatory filings for its vaccine in the U.K., Australia, New Zealand, Canada, the European Union, India, Singapore, South Korea, UAE, and Japan.
And, the World Health Organization granted a second Emergency Use Listing for NVX-CoV2373 on December 20, 2021.
"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 CEO, Novavax, in a press release issued on December 31, 2021.
"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 recently announced a two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive 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 engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.
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