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Novavax COVID-19 Booster Gets OK From FDA

The authorization offers another COVID-19 booster choice for adults.

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.

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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


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