Novavax COVID-19 Vaccine to be reviewed at U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices Meeting on July 19, 2022.

The CDC establishes its vaccine recommendations and schedules based on advice from ACIP. On July 13, 2022 the FDA granted emergency use authorization for the Novavax COVID-19 Vaccine, Adjuvanted for individuals aged 18 and over.

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.: The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 18 years of age and older to prevent Coronavirus Disease 2019 (COVID-19). The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.