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FDA Expands Pfizer-BioNTech Vaccine Authorization to Kids Ages 12 to 15

Two-dose mRNA shot gets OK for adolescents, vaccinations can start ‘right away’

adolescent receiving a COVID vaccination, wearing a mask

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En español | Kids as young as 12 are now eligible to get a vaccine that protects them from COVID-19

The U.S. Food and Drug Administration (FDA) on May 10 expanded the emergency use authorization (EUA) for Pfizer-BioNTech’s two-dose vaccine to include adolescents ages 12 to 15. And on May 12, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky signed off the on the decision, adding “providers may begin vaccinating them right away.” The vaccine has been authorized for Americans 16 and up since Dec. 11, 2020.

Acting FDA Commissioner Janet Woodcock, M.D., called the EUA expansion “a significant step in the fight against the COVID-19 pandemic” — one that brings “us closer to returning to a sense of normalcy and to ending the pandemic.” Since March 2020, schools, camps, sports leagues and extracurricular activities have been suspended or disrupted. And the mental health of many children and adolescents has suffered, federal data show.

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While children and adolescents “generally have a milder COVID-19 disease course as compared to adults,” the FDA says, they are not immune to a coronavirus infection. Approximately 1.5 million cases of COVID-19 have been reported to the CDC in adolescents ages 11 to 17 since the start of the pandemic in the U.S.; close to 500 children younger than 18 have died from COVID-19.

What’s more, children can transmit the virus to other people, making vaccination of younger age groups “important for achieving sufficient levels of population immunity to curb the pandemic,” an analysis from the Kaiser Family Foundation (KFF) points out. Adolescents account for 5.3 percent of the U.S. population and 26.6 percent of the U.S. population under the age of 16, according to KFF’s analysis.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

Vaccine provides strong protection in adolescents

Clinical trials testing the safety and effectiveness of the Pfizer-BioNTech vaccine in 12- to 15-year-olds found the vaccine to be 100 percent effective in preventing COVID-19. Health officials say there’s still not enough data to know whether the vaccine can prevent transmission of the virus. It’s also unclear how long protection from the vaccine lasts. 

Common Vaccination Side Effects in Adolescents

  • Pain at the injection site
  • Tiredness
  • Headache
  • Chills
  • Muscle pain
  • Fever
  • Joint pain

Source: FDA

Side effects observed in the adolescent clinical trials were similar to those experienced by older populations. The most commonly reported symptoms, which lasted one to three days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. More adolescents reported these side effects after the second dose than after the first.

Just like with adults, health officials warn that the vaccine should not be given to anyone with a known history of a severe allergic reaction to any component of the vaccine. Rare but serious allergic reactions, including anaphylaxis, have been reported. As part of the EUA, Pfizer will continue monitoring the safety of the vaccine in trial participants.

Next steps

An EUA is not the same as official FDA approval. Pfizer, however, is applying for formal approval for its mRNA vaccine — a process that will take at least six months. The company is also studying the vaccine’s safety and effectiveness in children as young as 6 months old.

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Moderna, which has an EUA for adults 18 and older, is testing its two-dose mRNA vaccine in adolescent and pediatric populations, too. The company said in a May 6 news release that it is in discussions with regulators “about a potential amendment to its regulatory filings.” Moderna is also on the cusp of seeking official FDA approval for its COVID-19 vaccine. 

Editor's note: This article was originally published on May 11. It's been updated to reflect new developments.

Rachel Nania writes about health care and health policy for AARP. Previously she was a reporter and editor for WTOP Radio in Washington, D.C. A recipient of a Gracie Award and a regional Edward R. Murrow Award, she also participated in a dementia fellowship with the National Press Foundation.

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