FDA Grants EUA for Novavax COVID-19 Vaccine for Adolescents

Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

The FDA has expanded the emergency use authorization (EUA) of Novavax’s protein-based COVID-19 vaccine to provide a two-dose primary series to prevent COVID-19 caused in adolescents aged 12 through 17.

The EUA decision was based on data from the ongoing pediatric expansion of the phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 75 sites in the United States. In this trial, the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% overall at a time when the Delta variant was the predominant circulating strain 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 from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse reactions were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine.

Adverse events included injection site pain/tenderness (75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain (49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection site swelling (8.0%), and injection site redness (7.5%). Most were mild-to-moderate in severity and lasted less than two days.

In July 2022 the FDA had granted EUA for a two-dose primary series in adults aged 18 and older, followed by a recommendation from the CDC Advisory Committee on Immunization Practices, and endorsement from the CDC.

Related: Novavax Seeks EUA for COVID-19 Booster

Additionally, Novavax has submitted an application to the FDA for emergency use authorization for a COVID-19 vaccine booster in adults 18 years or older.

Novavax’s vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with the company’s saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.