FDA gives full approval to Moderna's COVID-19 vaccine

Photo: Longhua Liao/Getty Images

Moderna has finally won full approval from the Food and Drug Administration for a COVID-19 vaccine named Spikevax.

Moderna's COVID-19 vaccine has been approved for use since December 18, 2020 under an emergency use authorization. Moderna now joins Pfizer as an FDA-approved vaccine.

The FDA-approved Moderna vaccine is being marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. The FDA said Spikevax meets the FDA's rigorous standards for safety, effectiveness and manufacturing quality.

Spikevax has the same formulation as the EUA Moderna COVID-19 vaccine and is administered as a primary series of two doses one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 vaccine, the FDA said. 

Moderna's COVID-19 vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older; as a third primary series dose for individuals 18 years of age and older who have been determined to be immunocompromised in some way; and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. 

It is also authorized for use as a single booster dose following completion of primary vaccination with a different available COVID-19 vaccine.

WHY THIS MATTERS 

The Moderna vaccine, as well as those from Pfizer and Johnson & Johnson, has long been in use to fight the coronavirus that has killed more than eight million people worldwide and over 886,000 in the United States, according to the Johns Hopkins data map.

An estimated 64% of the United States population has been fully vaccinated. The federal government has both urged and mandated vaccination – in some cases unsuccessfully – as the best prevention against the virus.

Acting FDA Commissioner Dr. Janet Woodcock said that for some individuals, FDA approval of the Moderna vaccine may instill additional confidence in making the decision to get vaccinated.

THE LARGER TREND

The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel and other countries, where the adolescent indication is also approved, according to Stéphane Bancel, CEO of Moderna. 

ON THE RECORD

"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus," Bancel said.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com