FDA grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for adolescents aged 12 through 17

• Novavax’ vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
• Doses of the Novavax COVID-19 Vaccine, Adjuvanted are now available and primary series immunizations for adolescents can begin once a policy recommendation from the CDC is received

GAITHERSBURG, Md., Aug. 19, 2022 — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received expanded emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.

“Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 Vaccine, Adjuvanted 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. Erck, President and Chief Executive Officer, Novavax. “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 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 U.S., to evaluate the safety and effectiveness of the Novavax COVID-19 Vaccine, Adjuvanted. In pediatric expansion, 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 U.S. 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 (AR) were low in number and balanced between vaccine and placebo groups, and not considered 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 participants 12 through 17 years of age, solicited ARs following administration of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were 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.

The next step for the vaccine is a policy recommendation for use from the Centers for Disease Control and Prevention (CDC). Doses of the Novavax COVID-19 Vaccine, Adjuvanted are available for use in adolescents upon the CDC’s recommendation.

In July 2022 the U.S. 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.

This project has been supported in part with federal funds from the Department of Health and Human Services (HHS); the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number MCDC2011-001.

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 12 years of age and older to prevent Coronavirus Disease 2019 (COVID-19).

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Read the full press release here.