The company is currently conducting trials in children as young as 6 months old.
The vaccine, now known as Spikevax, is Moderna’s first product to receive FDA licensure.
“We are grateful to the U.S. FDA for their thorough review of our application,” CEO Stéphane Bancel said in a statement.
Background: Like the vaccine from Pfizer and BioNTech, Moderna’s shot uses mRNA technology to trick the body’s cells into making harmless versions of the coronavirus spike protein. The immune system then creates protective antibodies based on these spike proteins.
The United States has purchased 500 million doses of the shot.
Moderna reported in early August that its shot is 93 percent effective six months after the second dose but that officials believed boosters would be necessary for adequate protection into the winter. The Biden administration announced Aug. 18 it would recommend booster doses for American adults eight months after their second shots of an mRNA vaccine, with the rollout anticipated by late September pending regulatory approval from the FDA.
The CDC endorsed offering additional doses of Pfizer’s and Moderna’s vaccines on Aug. 13 to certain immunocompromised individuals who may not have mounted a sufficient immune response after the primary two-dose series.
What’s next: Moderna is waiting to hear whether FDA will authorize its vaccine for use in teens. The company is running clinical trials of booster shots for adults and initial inoculations in children.