Novavax Statement on the U.S. Availability of the Novavax COVID-19 Vaccine, Adjuvanted
After the US Centers for Disease Control and Prevention (CDC) on Tuesday approved the Novavax COVID-19 vaccine, Adjuvanted (NVX-CoV2373) as an initial two-dose series in individuals 18 years of age and older, Novavax is pleased to announce that the doses shipped from its warehouses and received by the US government designated distribution centers today.
The CDC will now allocate doses to states — including state and local distribution centers, federal pharmacy partners, and federally qualified health centers — and they will have the ability to order doses starting Monday, July 25. It is expected that the doses will be available to consumers for vaccination shortly thereafter.
Information on where to access the Novavax COVID-19 vaccine, Adjuvanted, will be available at Vaccines.gov in the coming days. Most importantly, consumers should work with health care providers and local pharmacies to share vaccine requests in areas where it is not yet available to help make additional allocation decisions by the CDC. Novavax is committed to making the first protein-based COVID-19 vaccine option available to residents of the United States and will work closely with the United States government to ensure consumer access.
Use of Novavax COVID-19 Vaccine, Supplement in the United States
Novavax COVID-19 Vaccine, Adjuvanted is not approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by the U.S. Food and Drug Administration, under an Emergency Use Authorization (EUA) to provide an initial two-dose dose A series for individuals aged 18 and over to prevent coronavirus disease 2019 (COVID-19).
Emergency use of this product is permitted only for the duration of the declaration that circumstances exist that justify authorization of emergency use of the medicinal product under Section 564(b)(1) of the FD&C unless the declaration is terminated or the authorization revoked sooner.
Novavax COVID-19 Vaccine, Adjuvanted is authorized under an Emergency Use Authorization (EUA) to provide a two-dose core series for active immunization to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV) coronavirus disease 2019 (COVID-19) -2) In individuals aged 18 years and over.