Novavax submits application to the US FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a booster in adults aged 18 and older

• If authorized, Novavax’ vaccine would be the first protein-based COVID-19 booster for adults
• If authorized, the Novavax COVID-19 Vaccine, Adjuvanted could be used as a booster dose for adults aged 18 and older vaccinated with any other currently available COVID-19 vaccine

GAITHERSBURG, Md., Aug. 15, 2022 –– Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.

“It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Based on the data presented to the FDA’s VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants.”

This application for EUA is supported by data from Novavax’ Phase 3 PREVENT-19 trial conducted in the United States and Mexico, and from the UK-sponsored COV-BOOST Phase 2 trial. As part of an open-label booster phase of the PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted. The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose.

In the PREVENT-19 trial, following the booster, local and systemic reactions had a median duration of approximately two days. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose.

In the U.S., the FDA granted EUA, followed by a positive recommendation from the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), and endorsement from the CDC for a two-dose primary series in adults aged 18 and older in July. Doses of the Novavax COVID-19 Vaccine, Adjuvanted have been available for use in the U.S. since July.

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 18 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 18 years of age and older.

Read the full press release here.