Novavax asks FDA to authorize COVID-19 booster
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Novavax said Monday that it has asked the FDA to authorize a booster shot of its COVID-19 vaccine.
The company applied for emergency use authorization (EUA) of the booster for adults aged 18 years or older — either as a third booster dose for people who received a primary two-dose series of Novavax’s vaccine, or as a booster shot for people who received one of the other COVID-19 vaccines approved or authorized in the United States.
Novavax’s adjuvanted, protein-based vaccine was authorized by the FDA for emergency use and recommended by the CDC last month, giving the U.S. a fourth COVID-19 vaccine option.
As of Aug. 11, only around 9,800 of the more than 500,000 doses of the vaccine delivered in the U.S. had been administered, according to CDC data. Less than 2,500 people in the U.S. have received the full two doses of the vaccine, which are administered 3 to 8 weeks apart.
Novavax said the EUA submission for the booster shot was based on findings from the phase 3 PREVENT trial, in which a third dose of the vaccine given at least 6 months after the primary series induced an antibody response in participants similar to the primary series, and results from the phase 2 COV-BOOST trial, which indicated the vaccine was protective when used in a mix-and-match booster strategy.
Novavax said it is studying an omicron-specific COVID-19 vaccine and a bivalent vaccine that would include the original SARS-CoV-2 virus and the omicron variant. It also is evaluating a combination vaccine that would protect against both influenza and COVID-19.
References:
CDC. COVID-19 vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop. Accessed Aug. 15, 2022.
CDC. Novavax COVID-19, adjuvanted vaccine: Overview and safety. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/novavax.html. Accessed Aug. 15, 2022.
Novavax announces initial omicron cross-reactivity data from COVID-19 vaccine booster and adolescent studies. https://ir.novavax.com/2021-12-22-Novavax-Announces-Initial-Omicron-Cross-Reactivity-Data-from-COVID-19-Vaccine-Booster-and-Adolescent-Studies. Published Dec. 22, 2021. Accessed Aug. 15, 2022.
Novavax submits application to the U.S. FDA for emergency use authorization for Novavax COVID-19 vaccine, adjuvanted as a booster in adults aged 18 and older. https://ir.novavax.com/2022-08-15-Novavax-Submits-Application-to-the-U-S-FDA-for-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine,-Adjuvanted-as-a-Booster-in-Adults-Aged-18-and-Older. Published Aug. 15, 2022. Accessed Aug. 15, 2022.
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