FDA Approved Moderna (Spikevax) COVID-19 Vaccine

On February 4, 2022, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the Moderna COVID-19 Vaccine in adults 18 and older.


The Moderna COVID-19 vaccine, now being marketed as Spikevax, received full U.S. Food and Drug Administration (FDA) approval on January 31, 2022, for people ages 18 years and over. The Moderna (Spikevax) vaccine has been available under the Emergency Use Authorization (EUA) for people 18 years of age and older since December 18, 2020. With the full FDA approval of Modera (Spikevax), the United States now has two fully approved COVID-19 vaccines. American Indians and Alaska Natives (AI/ANs) now have access to two approved vaccines, Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax) to protect elders, children, their communities and themselves from severe illness and hospitalization.


Spikevax has the same formula as the EUA Moderna COVID-19 vaccine and is given as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna vaccine to provide the vaccination series. The Moderna (Spikevax) vaccine meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality required for a full FDA approval. Read more about Spikevax’s FDA approval here.