Moderna COVID Vaccine Gets Full FDA Approval

TUESDAY, Feb. 1, 2022

Moderna’s COVID-19 vaccine has received full approval for use in people 18 and older, the U.S. Food and Drug Administration announced Monday.

The vaccine, which has been available for that age group under emergency use authorization (EUA), will be marketed as Spikevax. It’s not yet fully approved or authorized for use in people younger than 18.

This is the second COVID-19 vaccine to receive full approval from the FDA. In August, the agency approved Pfizer’s Comirnaty vaccine for use in people aged 16 and older, and it’s also authorized for use in people ages 5 to 15.

“While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” Acting FDA Commissioner Dr. Janet Woodcock, said in an agency news release.

Spikevax is given as a series of two doses, one month apart, and can be used interchangeably with the EUA-approved vaccine to finish the vaccination series, the FDA said.

“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… for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history, as it is our first product to achieve licensure in the U.S.,” Moderna CEO Stéphane Bancel said in a company statement. “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.”

The EUA-approved Moderna vaccine remains available as a two-dose primary series for people 18 and older, as a third primary series dose for certain immunocompromised people 18 and older, and as a single booster dose for people 18 and older at least five months after completing a primary series of the vaccine.

It is also authorized for use as a “mix-and-match” single booster dose for people 18 and older who have completed primary vaccination with a different COVID-19 vaccine.

Nearly 75 million people in the United States have completed their initial series with the Moderna vaccine, and about 38.5 million people have gotten a Moderna booster shot, the latest CDC data shows.

“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards,” Marks added.

Under the approval, Moderna must conduct post-marketing studies to further assess the risks of two heart conditions — myocarditis and pericarditis — following vaccination with Spikevax.

And though there is no FDA requirement to do so, Moderna will also conduct other post-marketing safety studies, including one to evaluate pregnancy and infant outcomes after women receive Spikevax during pregnancy.

More information

Visit the U.S. Food and Drug Administration for more on COVID vaccines.

SOURCES: U.S. Food and Drug Administration, news release, Jan. 31, 2022; Moderna, statement, Jan. 31, 2022

Robert Preidt and Robin Foster

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