Novavax Statement on U.S. Vaccinations with the Novavax COVID-19 Vaccine, Adjuvanted Underway
- Consumers can access dose availability in their local market via Vaccines.gov
- Novavax’ COVID-19 Vaccine, Adjuvanted, is the first protein-based COVID-19 vaccine option available in the U.S.
Novavax is pleased to announce that doses of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) as a two-dose primary series in individuals 18 years of age and older are now available in U.S. local markets and vaccinations are underway. The U.S. Centers for Disease Control and Prevention (CDC) allocated doses to the states in July following the CDC’s endorsement following the Advisory Committee on Immunization Practices’ (ACIP) unanimous recommendation.
Information about where to access the Novavax COVID-19 Vaccine, Adjuvanted is available on Vaccines.gov. Importantly, consumers should work with their healthcare providers and local pharmacies to share requests for the vaccine in areas where it is not yet available to help inform additional allocation decisions by the CDC. Novavax is committed to making the first protein-based COVID-19 vaccine option available to the U.S. population and will be working closely with the U.S. Government to ensure consumers have access.
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.
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.