FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine in Adolescents Aged 12 Through 17

The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.

Officials with the FDA have granted an expanded Emergency Use Authorization (EUA) to Novavax for its COVID-19 vaccine, adjuvanted for adolescents 12 through 17 years of age, according to a press release. The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.

The expanded EUA allows for a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents. Doses are now available and primary series immunizations for adolescents can begin once the CDC releases a policy recommendation.

“Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 vaccine, adjuvanted, will hopefully increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season,” said Stanley C. Erck, president and CEO of Novavax, in a press release. “We hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination based on parents’ and caregivers’ familiarity with protein-based vaccines used in other disease areas.”

The FDA decision was based on data from the ongoing pediatric expansion of the phase 3 PREVENT-19 trial, including 2247 adolescents aged 12 through 17 years across 75 sites in the United States. In this expansion, the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% overall during the period in which the Delta variant was the predominant circulating strain of SARS-CoV-2 in the United States. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults.

Safety data showed that the vaccine was generally well-tolerated. Serious and severe adverse events (AEs) were low in number, were balanced between the vaccine and placebo groups, and were not considered to be related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose.

No new safety signal was observed through the placebo-controlled portion of the study. Among adolescent participants, solicited AEs following administration of any dose included injection site pain or tenderness (75%), headache (56.9%), fatigue or malaise (57.9%), muscle pain (49%), nausea or vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection site swelling (8%), and injection site redness (7.5%). Most were mild to moderate in severity and lasted less than 2 days.

The next step for the vaccine will be a policy recommendation from the CDC, and doses of the vaccine will be available for adolescents upon the CDC’s recommendation. In July, the FDA granted an EUA for a 2-dose primary series of the vaccine in adults aged 18 years and older, followed by a recommendation from the CDC Advisory Committee on Immunization Practices and an endorsement from the CDC.

REFERENCE

US FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17. News release. Novavax; August 19, 2022. Accessed August 22, 2022. https://ir.novavax.com/2022-08-19-U-S-FDA-Grants-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine,-Adjuvanted-for-Adolescents-Aged-12-Through-17