The U.S. Centers for Disease Control and Prevention (CDC) has endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that Novavax’s COVID-19 vaccine be used as another primary series option for adults ages 18 years and older.
Novavax is a protein subunit vaccine. These vaccines package harmless proteins of the COVID-19 virus alongside another ingredient called an adjuvant that helps the immune system respond to the virus in the future.
Vaccines using protein subunits have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines used in the United States today include those to protect against influenza and whooping cough.
Two doses of Novavax are given in the primary series, 3–8 weeks apart. People who are moderately or severely immunocompromised should also receive 2 doses, given 3 weeks apart (a 3rd primary dose is not currently authorized).
Novavax COVID-19 vaccine is not authorized for use as a booster dose.
The CDC will now allocate doses to the 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 on Monday, July 25. Doses are expected to be available to consumers for vaccinations shortly thereafter.
Information about where to access the Novavax COVID-19 Vaccine, Adjuvanted will be available on Vaccines.gov in the coming days. 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.
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.
