FDA grants emergency use authorization for Novavax COVID-19 vaccine(NVX-CoV2373), adjuvanted as a booster for adults
Novavax, Inc. announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the FDA to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine
The FDA EUA decision was based on data from the Phase III Prevent-19 clinical trial and from the U.K.-sponsored COV-BOOST trial. In the Phase III trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants aged 18 and older approximately eight or 11 months after their primary series. Following a booster dose, antibody levels increased significantly relative to pre-boost levels, rising above levels associated with protection in the Phase III trials. Neutralizing antibodies also increased by 34- to 27-fold compared to pre-boost levels when boosted at eight or 11 months
In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted increased antibody titers when used as a third dose following initial dosing with another authorized COVID-19 vaccine (heterologous boosting).
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