The full approval for people ages 18 and older was based on follow-up data showing “high efficacy and favorable safety approximately six months after the second dose.”
The vaccine had already been available since December 2020 under an emergency use authorization, but full approval provides an extra emphasis.
Acting FDA Commissioner Janet Woodcock said she hoped the move gives some people additional confidence in the vaccine.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” she said in a statement. “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.”
Pfizer’s vaccine already received full approval in August.
- Pfizer begins application to FDA for vaccine for kids under 5
- Overnight Health Care — Pfizer seeks green light for young kids’ vax
“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,” Moderna CEO Stéphane Bancel said in a statement. “The totality of real-world data and the full [approval] 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.”
A booster shot of the Moderna vaccine is also recommended five months after the second shot.
About 74 percent of adults are now fully vaccinated, according to Centers for Disease Control and Prevention data. The numbers are much lower for boosters, which are crucial for achieving higher protection against the omicron variant, with 44 percent of fully vaccinated adults having received a booster, according to the public health agency.