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

(RTTNews) - 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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