Novavax Submits EUA Application To FDA For COVID-19 Booster In Adults

Biotechnology company Novavax, Inc. (NVAX) announced Monday that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent COVID-19 caused by the severe acute respiratory syndrome SARS-CoV-2 as a homologous and heterologous booster in adults aged 18 and older. If authorized, Novavax' vaccine would be the first protein-based COVID-19 booster for adults.

This application for EUA is supported by data from Novavax' Phase 3 PREVENT-19 trial conducted in the United States and Mexico, and from the UK-sponsored COV-BOOST Phase 2 trial.

As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted.

The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose.

Safety reporting of reactogenicity events showed an increasing incidence across all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, reflecting the increased immunogenicity seen with a third dose.

Doses of the Novavax COVID-19 Vaccine, Adjuvanted have been available for use in the U.S. since July.

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