FDA set to authorize Pfizer COVID-19 vaccine for children ages 12 to 15

Photo of Pfizer vaccine
Marco Verch/Creative Commons
Following a trial of Pfizer's COVID-19 vaccine, which was demonstrated to be highly effective in children, the vaccine is waiting on authorization from the Food and Drug Administration for use in children ages 12 to 15. Berkeley Unified School District spokesperson Trish McDermott noted how the potential authorization would help mitigate risks for middle schools and high schools. ( Marco Verch under CC BY-SA 2.0.)

Related Posts

Children between 12 to 15 years old may soon be able to receive the Pfizer COVID-19 vaccine, pending approval from the Food and Drug Administration, or FDA, early next week. 

The development follows results from a Pfizer trial, which showed the vaccine to be highly effective in adolescents even more so than in adults. The trial saw 100% efficacy and a strong antibody response in its 2,260 adolescent participants, according to a Pfizer press release.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, chief executive officer of Pfizer, in the press release. “We plan to submit these data to FDA … with the hope of starting to vaccinate this age group before the start of the next school year.”

The approval would amend the current emergency authorization for vaccine use in teenagers ages 16 and older, according to the press release.

The expanded vaccine rollout would also assist the return of students to in-person instruction in the fall. According to Berkeley Unified School District, or BUSD, spokesperson Trish McDermott, the approval would help mitigate risks for the middle schools and high schools during their periods of reopening in the BUSD.

“The district is evaluating news about the availability of vaccines for youth age 12+ and potential distribution channels at this time,” McDermott said in an email. “Vaccines are one of several important risk mitigation efforts in slowing the spread of COVID-19 in our community.”

The FDA’s pending approval of Pfizer’s vaccine for adolescents would be followed by a federal vaccine advisory committee meeting to make recommendations on vaccine use, as noted in an article from The Mercury News. Vaccine administration would begin a few days after the Centers for Disease Control and Prevention adopts the committee’s recommendations.

Pfizer is not the only company seeking approval for adolescent use of their vaccine. The Moderna vaccine trial results for adolescents ages 12 to 15 years old are expected to be published soon and, if successful, may contribute to a larger available vaccine supply for adolescents, according to an article from The New York Times.

The New York Times article also noted that Pfizer is expected to apply for emergency authorization to vaccinate the next age group — children between the ages of 2 and 11 — around September this year.

“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” said Ugur Sahin, CEO of BioNTech, in the Pfizer press release. “It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”

Contact Cindy Liu at [email protected] and follow her on Twitter at @_CindyLiu_.