Novavax Seeks EUA for COVID-19 Booster

Novavax has submitted an application to the FDA for emergency use authorization (EUA) for its protein-based COVID-19 vaccine booster in adults 18 years or older.

This application is supported by data from Novavax’s 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.

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 vaccine induced a significant antibody response when used as a third booster dose. In the PREVENT-19 trial, following the booster, local and systemic reactions had a median duration of approximately two days

Last month, the FDA granted an EUA for the primary series of the vaccine. This followed the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) positive vote to recommend the FDA grant EUA for the vaccine. Novavax’s COVID-19 vaccine has already received authorization for use in people 18 and over from more than 40 countries, in addition to emergency use listing from the World Health Organization.

The Novavax COVID-19 vaccine is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant.

Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual, the FDA said. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.