CDC Backs Full Approval of Moderna COVID Vaccine

This follows a similar move made Jan. 31 by its sister agency, the U.S. Food and Drug Administration.

The vaccine, which had before been available for that age group only 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.

“We now have another fully approved COVID-19 vaccine,” CDC director Dr. Rochelle Walensky said in an agency statement. “If you have been waiting for approval before getting vaccinated, now is the time to join the nearly 212 million Americans who have already completed their primary series. CDC continues to recommend that people remain up to date on their COVID-19 vaccines, including getting a booster shot when eligible.”

The CDC gave full approval to the Moderna vaccine following the recommendation of its Advisory Committee on Immunization Practices (ACIP). According to the CDC statement, "the ACIP recommendation comes more than a year after the committee’s interim recommendation, and after an exhaustive review of the scientific evidence demonstrating safety and effectiveness, and supports continued use of the now licensed vaccine."

Moderna's vaccine is the second COVID-19 vaccine to receive full approval from both the FDA and the CDC. In August, both agencies 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 FDA news release at the time her agency gave its approval.

Moderna's 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 on Jan. 31. "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.

"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," noted Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

As a condition of the FDA's 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.