FDA Approves Pfizer's COVID Vaccine for Use in 12- to 15-Year-Olds

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data,” said Acting FDA Commissioner Dr. Janet Woodcock

Female doctor giving covid-19 vaccine to a boy
Adolescent getting COVID-19 vaccine. Photo: Getty Images

Adolescents aged 12 to 15 are now approved to get Pfizer-BioNTech's COVID-19 vaccine, the Food and Drug Administration said Monday, after a "rigorous and thorough" evaluation to ensure its safety.

Parents cannot immediately sign up their kids for an appointment, however. Advisers at the Centers for Disease Control first need to meet to go over the data and the FDA's decision before making their own recommendation, but they are expected to act quickly and endorse the vaccine for use.

A full approval will widen the number of Americans who are now eligible for a COVID-19 vaccine and move the country closer to reaching herd immunity against the virus.

The FDA was expected to approve Pfizer's vaccine for emergency use in 12- to 15-year-olds this week, after a clinical trial of 2,300 adolescents showed that it was extremely effective, providing 100% protection against the virus.

"Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

Prior to the FDA's announcement, Pfizer's vaccine was only approved for people aged 16 and up. The other two vaccines in use in the U.S., from Moderna and Johnson & Johnson, are allowed in ages 18 and up.

"The FDA's expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," Woodcock said. "Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic."

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Both Pfizer and Moderna are currently testing their vaccines on younger age groups — kids between the ages of 6 months to 12 years old — in the hopes of vaccinating them by early next year.

As of May 10, more than 58% of American adults have received at least one dose of a COVID-19 vaccine, and 44.3% are now fully vaccinated against the virus, the CDC reports. New cases are also dropping significantly — infections are now averaging around 41,000 a day, a decrease of 30% over the last 14 days, according to The New York Times.

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