FDA Grants Emergency Use Authorization for Novavax Adjuvanted COVID-19 Vaccine as Booster for Adults

The Novavax COVID-19 vaccine, adjuvanted has received emergency use authorization (EUA) from the FDA as a first booster dose at least 6 months after primary vaccination with an authorized COVID-19 vaccine in adults 18 years of age and older who cannot receive an mRNA bivalent COVID-19 booster vaccine.

The decision was based on data from the phase 3 PREVENT-19 trial and from the UK-sponsored COV-BOOST trial. In the PREVENT-19 trial, a single booster dose of the vaccine was administered to healthy adult participants aged 18 years and older approximately 8 or 11 months after their primary series. Following this dose, antibody levels increased significantly relative to pre-booster levels, rising above levels associated with protection in the phase 3 trial. Neutralizing antibodies also increased by 34- to 27-fold compared to pre-booster levels when administered at 8 or 11 months post-primary series.

In the COV-BOOST trial, the Novavax COVID-19 vaccine, adjuvanted increased antibody titers when used as a third dose following initial dosing with another authorized COVID-19 vaccine. Following the booster, local and systemic reactions had a median duration of approximately 2 days.

The incidence of grade 3 or higher adverse events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all 3 doses of the vaccine, often seen with increased immunogenicity. Among participants 18 years of age and older, solicited adverse reactions following administration of a booster dose of the Novavax COVID-19 vaccine, adjuvanted were injection site pain or tenderness (81.1%), fatigue or malaise (63.4%), muscle pain (63%), headache (52.9%), joint pain (30.3%), nausea or vomiting (14.7%), injection site swelling (8.4%), injection site redness (6.3%), and fever (6.3%).

“The US now has access to the Novavax COVID-19 vaccine, adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, president and CEO of Novavax, 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. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”

The next step for the vaccine is a policy recommendation from the CDC for its use as a first booster. Doses are available for the United States pending this final step.

Several countries already have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose. In the United States, the FDA granted an EUA for a 2-dose primary series with the Novavax COVID-19 vaccine in adults aged 18 years and older in July 2022, and for adolescents aged 12 through 17 years in August. The CDC also recommended the vaccine for use as a primary series in both age groups.

REFERENCE

US FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults. News release. Novavax; 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