Novavax Investor Relations – Press Releases and Statements

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Novavax Statement on U.S. Vaccinations with Novavax COVID-19 Vaccine, Adjuvanted In Progress

  • Consumers can access dose availability in their local market via Vaccines.gov
  • Novavax’s COVID-19 vaccine, with adjuvant, is the first protein-based COVID-19 vaccine option available in the United States

Novavax is pleased to announce that doses of the Novavax COVID-19 vaccine, adjuvanted (NVX-CoV2373) two-dose primary series in individuals 18 years of age and older are now available in local U.S. markets and that vaccinations are in class. The US Centers for Disease Control and Prevention (CDC) assigned doses to states in July after CDC approval following the unanimous recommendation of the Advisory Committee on Immunization Practices (ACIP).

Information on access to the Novavax COVID-19 vaccine, with adjuvant is available at Vaccines.gov. Importantly, consumers should work with their healthcare providers and local pharmacies to share vaccine requests 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 American people and will work closely with the U.S. government to ensure consumer access.

Use of the Novavax COVID-19 vaccine, adjuvanted in the United States

The Novavax COVID-19 vaccine, with adjuvant, has not been approved or cleared by the United States Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA, under an emergency use authorization (EUA) to provide a two-dose primary treatment. series to people 18 years and older to prevent coronavirus disease 2019 (COVID-19).

Emergency use of this product is authorized only for the duration of the declaration of the existence of circumstances 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 the authorization is revoked earlier. .

Authorized use

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 people 18 years of age and older.

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