FDA Will Authorize Pfizer COVID Vaccine for Ages 12 and Older: Report

Motorists make their way past a sign announcing “Pfizer Today” available at the Cal State Los Angeles COVID-19 vaccine site in Los Angeles, California on Monday. Photo: Frederic J. Brown/AFP via Getty Images

The Food and Drug Administration is preparing to authorize the use of the Pfizer-BioNTech coronavirus vaccine for adolescent kids aged 12-15 years within a week, according to federal officials who spoke with the New York Times. If and when that happens, it would mark the first time any coronavirus vaccine has been authorized for emergency use for Americans under the age of 16 — a long-awaited development for countless parents in the U.S., as well as the beginning of a new phase in the country’s vaccine rollout.

Pfizer has previously reported that its vaccine was found to be as effective in the 12-15 age group as it was in adults, with no additional side effects, in its clinical trial involving adolescents. (The side effects were in line with what recipients aged 16-25 experienced.) FDA authorization of the vaccine for the new age group would likely be followed by a quick review from the Centers for Disease Control and Prevention’s vaccine advisory panel, as was the case for other previous vaccine authorizations. After the panel makes its recommendation, vaccine administration sites would likely be able to start giving out doses to adolescents immediately.

As the Times notes, amid consistent supply and weakening demand, there is currently a vaccine surplus in the U.S., including some 31 million doses of the Pfizer vaccine which have already been delivered throughout the country — by itself would roughly be enough to fully vaccine every adolescent. While all people 16 and older are currently eligible to receive a COVID vaccine, it’s not clear if all states would immediately expand that eligibility to ages 12 and over following the FDA authorization of the Pfizer vaccine.

One epidemiologist who spoke with the Times, the Johns Hopkins Center for Health Security’s Jennifer Nuzzo, also pointed out that giving the vaccine to American adolescents, at a time when most other countries are unable to get enough doses, might not be ethical. “I do think we need to have a national and global conversation about the ethics of our vaccinating kids who are low risk for serious complications from the virus when there aren’t enough vaccines in the world to protect high risk adults from dying,” she said.

This post has been updated.

FDA Set to Authorize Pfizer COVID Vaccine for Adolescents