Novavax Gains EUA for Adjuvanted COVID-19 Booster Vaccine
Novavax has received FDA Emergency Use Authorization (EUA) for its adjuvanted COVID-19 vaccine for use as a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine in individuals 18 years and older.
The authorization also includes individuals for whom an FDA-authorized messenger RNA bivalent COVID-19 booster vaccine is not clinically appropriate, as well as those who are 18 years and older and who would otherwise not receive a booster dose of a COVID-19 vaccine.
The EUA was supported by results from a late-stage study in which participants who received a booster dose after a primary vaccination series showed significantly increased antibody levels. In a separate study in the UK, the adjuvanted vaccine also increased antibody levels when used as a third dose following initial dosing with another authorized COVID-19 vaccine.
Novavax’s COVID-19 vaccine is a protein-based vaccine engineered from the first strain of the SARS-CoV-2 virus that started the COVID-19 pandemic.