HealthDay News — The U.S. Centers for Disease Control and Prevention gave its full approval to the Moderna COVID-19 vaccine for use in people 18 years and older. 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 is not yet fully approved or authorized for use in people younger than 18 years.
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.”
The Moderna vaccine is the second COVID-19 vaccine to receive full approval from both the FDA and the CDC. In August, both agencies approved the Pfizer Comirnaty vaccine for use in people aged 16 years and older, and it is also authorized for use in people aged 5 to 15 years.
The Moderna Spikevax vaccine is given as a series of two doses, one month apart, and can be used interchangeably with the EUA-approved vaccines to finish the vaccination series, the FDA said. The EUA-approved Moderna vaccine remains available as a two-dose primary series for people 18 years and older, as a third primary series dose for certain immunocompromised people 18 years and older, and as a single booster dose for people 18 years 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 years and older who have completed primary vaccination with a different COVID-19 vaccine.
As a condition of the FDA approval, Moderna must conduct postmarketing studies to further assess the risks for 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 postmarketing safety studies, including one to evaluate pregnancy and infant outcomes after women receive Spikevax during pregnancy.