Federal regulators issued their full approval Monday of the Moderna COVID-19 vaccine, the second approval of a COVID vaccine outside of its emergency use authorization.
The FDA issued its full approval of the vaccine after considering data from roughly 14,000 vaccine recipients and 14,000 placebo recipients. In the more than 28,000 adults sampled, the two-dose vaccine was 93 percent effective at preventing COVID-19 infection and 98 percent effective at preventing serious illness.
The FDA also determined that the vaccine is safe to receive after analyzing data from a pool of more than 30,000 vaccine recipients and placebo recipients, with the most common reported side effects including fatigue, headache, redness and swelling at the injection site and fever.
“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 a statement.
The vaccine has been available to adults under emergency use approval since December 2020, along with the similar mRNA vaccine developed by Pfizer-BioNTech.
Since then, the FDA has expanded its emergency use authorization for the Moderna vaccine to include its use as a booster dose for people who completed their initial vaccine series at least five months prior.
With Monday’s announcement, Moderna’s vaccine will now be marketed as Spikevax.
“Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”