- The FDA is reportedly set to OK the Pfizer COVID-19 vaccine for 12- to 15-year-olds by next week.
- Pfizer said in March that its vaccine was highly effective in a trial of over 2,000 adolescents.
- Nearly 150 million Americans had gotten at least one dose of a vaccine as of May 3, CDC data showed.
- See more stories on Insider’s business page.
The Food and Drug Administration is set to authorize the use of the Pfizer-BioNTech COVID-19 vaccine for adolescents ages 12 to 15 as early as next week, The New York Times reported Monday.
Following FDA authorization, an advisory panel from the Centers for Disease Control and Prevention will review data and results from clinical trials to draft recommendations on the use of the vaccine for that age group, according to The Times’ report.
Pfizer announced in March that its vaccine was highly effective in a trial of more than 2,000 adolescents and that the vaccine was “well tolerated” among those ages 12 to 15. Pfizer said the side effects of the vaccine experienced by that age group were similar to those of 16- to 25-year-olds.
The CDC opened up vaccine eligibility to people who were 16 years or older in April, and those who were 16 or 17 years old were allowed to receive only Pfizer’s shot, while those 18 and up were authorized to receive Moderna’s or Johnson & Johnson’s vaccines as well.
Pfizer CEO Albert Bourla said in a statement in March that the company shared the “urgency to expand the authorization of our vaccine to use in younger populations.” He said he hoped the clinical-trial data would prompt officials to start vaccinating the age group “before the start of the next school year.”
An FDA spokeswoman declined to comment to The Times on the agency’s timeline of authorizing the vaccine for adolescents.
“We can assure the public that we are working to review this request as quickly and transparently as possible,” the spokeswoman told The Times.
Nearly 150 million Americans had received at least one dose of a COVID-19 vaccine as of May 3, according to data from the CDC, equating to roughly 44% of the US population.
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