US FDA Grants EUA for Novavax COVID-19 Booster Shot

The FDA on October 19 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. 

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 to healthy adults 8 to 11 months after the primary series, which led to a significant increase in antibody levels compared with pre-booster levels. Neutralizing antibodies also increased by 34- to 27-fold compared to pre-booster levels.

In COV-BOOST, an increase in antibody titers was seen following administration of the booster as a third dose, after an initial dosing with another authorized COVID-19 vaccine. Local and systemic reactions lasted on average about 2 days and were similar to expected including injection site tenderness, fatigue/malaise, headache, and joint pain.

“According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose,” said Stanley C Erck, president and chief executive officer of Novavax in a company statement. “Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults."

The Centers for Disease Control and Prevention is now reviewing the authorization. Doses of the vaccine are available for use in the US, according to the company, as soon as the CDC makes its recommendation.