FDA to authorize Pfizer vaccine for kids ages 12-15 by early next week

Pfizer has applied for emergency use authorization for its COVID-19 vaccine for teens and children ages 12 to 15.


Pfizer, one of the first pharmaceutical companies to receive emergency use authorization for the COVID-19 vaccine, is now applying for authorization for use in children and teens ages 12-15. The US Food and Drug Administration is set to authorize the Pfizer/BioNTech coronavirus vaccine for that age bracket as early as next week.

A federal government official told CNN the FDA is currently reviewing data submitted by Pfizer to support its extended use. At the end of March, a clinical trial involving 2,260 12 to 15-year-olds showed the vaccine was 100% effective and well-tolerated in participants.

The Pfizer vaccine is currently approved for emergency use in the US for people 16 and older.

In the adolescent clinical trial, half the participants received the two-dose Pfizer regimen, and the other half were given placebo shots. Data from Pfizer shows the vaccine triggered a stronger immune response in teenagers than in young adults. During the trial, only 18 cases of COVID-19 were reported among the kids who participated, and all 18 were found in kids who received the placebo shot.

If the FDA grants the authorization, the Centers for Disease Control and Prevention's vaccine advisory will then meet to discuss the data from the clinical trial and make official recommendations for the vaccine's use in adolescents. Expanding the availability of the vaccine to this age group will be a major boost toward eventual herd immunity. Many parents are anxious to protect their children during summer sports and activities, and ahead of the 2021-2022 school year.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, spoke with The New York Times that while she can't comment on the agency's decision, the FDA is working on it.

"We can assure the public that we are working to review this request as quickly and transparently as possible," she said.

Extending emergency use authorization to children younger than 12 will be a different process. The official who spoke with CNN explained that younger children will need stronger considerations before official recommendations can be released.

Currently, over 100 million adults in the US have been fully vaccinated. Even though children have been statistically less likely to suffer from severe COVID-19, with variants of the virus being more transmissible overall, the timing of this latest vaccine development is critical—children now account for 22% of new COVID-19 cases in the US.

In This Article