COVID-19 vaccine.Photo: Chip Somodevilla/Getty
The vaccine, named Spikevax, now has full FDA approval for anyone aged 18 and up. It was previously under an emergency use authorization, which the FDA granted in Dec. 2020, and has been administered more than 200 million times in the U.S.
The FDA’s full approval means that the agency has rigorously vetted and reviewed scientific data that proving the vaccine’s safety and effectiveness, as it does with all vaccines.
Moderna’s Spikevaxjoins Pfizer-BioNTech’s formulationas the two fully-approved COVID-19 vaccines in the U.S.
FDA acting commissioner Dr. Janet Woodcock said that the full approval for Moderna is a “significant step” in getting more Americans vaccinated and ending the COVID-19 pandemic.
“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 saidin 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.”
As of Feb. 2, nearly 75.5% of Americans have received at least one dose of a COVID-19 vaccine, and just under 64% are fully vaccinated. Nearly all Americans are now eligible for vaccination, after the FDA approved Pfizer’s vaccine for use in kids 5 and up in November, and the last remaining age group — children 6 months to 4 years old —is expected to be approved this month.
On Tuesday, Pfizer asked the FDA to approve their vaccine for use in children 6 months to 4 years old. The request came at the urging of the FDA — a surprise move, as typically companies make that decision on their own — but the federal agency said that it is necessary with omicron “having a much greater toll on children,“they told USA Today.
“In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available, including the data that it has recently collected during the omicron surge,” the FDA told the outlet.
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source: people.com
