Moderna COVID-19 vaccine receives full FDA approval for adults
January 31, 2022
The Food and Drug Administration granted full approval to Moderna's two-dose COVID-19 vaccine, marketed under the name Spikevax, more than a year after authorizing it for public use.
“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19," said acting FDA Commissioner Janet Woodcock. "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."
The two-dose regimen of the Moderna vaccine is what has gotten full approval, while third doses for immunocompromised people and booster doses for adults are still under Emergency Use Authorization, a pathway used during emergency situations when speed is of the essence. The FDA has already given full approval to Pfizer-BioNTech's mRNA vaccine, which was the first to receive regulatory authorization under Emergency Use standards in December 2020. Unlike the Pfizer shots, which were initially granted an Emergency Use Authorization for adults 16 and up, the Moderna vaccine has been fully approved for adults 18 and older.
Federal officials hope that approving the second COVID-19 vaccine will make a dent in the remaining portion of people who have yet to get the shots. A lack of full-throated endorsement from regulators has kept many from getting the vaccines, fearing that the FDA sped through safety and efficacy trials for the sake of getting a shot out to the public quickly during a national emergency.
“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," Woodcock said.
To date, nearly 64% of the U.S. population five and older, nearly 212 million people, has been fully vaccinated. Of that total, more than 74.5 million people have opted for the Moderna vaccine.
https://www.washingtonexaminer.com/policy/moderna-covid-19-vaccine-receives-full-fda-approval-for-adults