Novavax COVID-19 Booster Gets OK From FDA

The FDA has issued an emergency use authorization (EUA) for a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) in adults aged 18 years and older.¹ The booster dose should be administered at least 6 months following the completion of a primary vaccination series with an authorized or approved COVID-19 vaccine. It can be administered to patients who do not have access to an authorized bivalent COVID-19 booster, in whom a bivalent booster would not be clinically appropriate, or who chose to receive the Novavax booster because they would not otherwise receive a COVID-19 booster dose.

The decision was supported by data from the phase 3 PREVENT-19 clinical trial (NCT04611802) as well as the UK COV-BOOST trial. In PREVENT-19, a single booster dose was administered 8 to 11 months after the primary series, which led to a significant increase in antibody levels compared with pre-booster levels. In COV-BOOST, an increase antibody titers was seen following administration of the booster as a third dose, after an initial dosing with another authorized COVID-19 vaccine.

Stanley C. Erck, President and CEO at Novavax, highlighted the importance of the authorization in a press release. “According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose,” he said. “Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults."

The CDC is now reviewing the authorization. Once the agency makes its recommendation, the vaccine will be available for use.

References

1. U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine, adjuvanted as a booster for adults. News release. October 19, 2022. Accessed October 19, 2022. https://ir.novavax.com/2022-10-19-U-S-FDA-Grants-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine,-Adjuvanted-as-a-Booster-for-Adults