FDA Expands Novavax EUA for Use in Adolescents Aged 12 to 17

The vaccine was previously authorized under an EUA for adults aged 18 and older.

The Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV237) has received an expansion of the emergency use authorization (EUA) from the FDA, the company announced today. The expanded EUA allows the vaccine to be used as a 2-dose primary series for adolescents aged 12 through 17.1

The decision is based on data from the ongoing Phase 3 PREVENT-19 clinical trial (NCT04611802). In an ongoing pediatric expansion, investigators are evaluating the safety and effectiveness of the Novavax COVID-19 vaccine in 2247 adolescent participants across 75 US sites. According to recent data, “the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI, 37.55%-92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States.”

“Having more vaccine options for use in both adults and adolescents…will hopefully help 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. Erick, president and CEO of Novavax.

In addition to effectiveness data, safety data from the pediatric expansion showed the Novavax vaccine to be “generally well-tolerated.” Rates of serious and severe adverse reactions were low, and both local and systemic reactogenicity was “generally lower than or similar to adults after the first and second dose.”

The EUA update follows the initial EUA granted by the FDA in July 2022, which allowed the vaccine to be used as a 2-dose primary series in adults aged 18 and older. This initial EUA was followed by a recommendation from the Advisory Committee on Immunization Practices (ACIP) and endorsement by the CDC.

Reference

  1. U.S. 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