Novavax submits final data packages to FDA as prerequisite to Emergency Use Authorization application request for COVID-19 vaccine.
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 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.
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Novavax, Inc. announced that it submitted an application to the FDA for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.
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