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Teens received the Pfizer-BioNTech vaccine in clinical trials. Paul Bersebach/MediaNews Group/Orange County Register/Getty Images
  • The FDA has approved a COVID-19 vaccine for younger adolescents.
  • Until now, the Pfizer-BioNTech vaccine had only been approved for people over age 16.
  • The FDA is also studying how the vaccine works for children as young as 6 months old.

The Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech COVID-19 vaccine for children and teens between 12 and 15 years old.

“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,” said acting FDA Commissioner Janet Woodcock, MD, in a statement. “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.”

In early April, Pfizer and BioNTech requested an amendment of the existing emergency use authorization (EUA) to expand use of the vaccine to this younger age group.

The companies reported at the end of March that a phase 3 clinical trial involving 2,260 12- to 15-year-olds showed that the vaccine had an efficacy of 100 percent in this age group. It was also well tolerated.

Adolescents who received the vaccine produced strong antibody responses, similar to what was seen in earlier trials among people 16 to 25.

“This is welcome news,” Dr. Christina Johns, senior medical adviser for PM Pediatrics, said last week when the news was leaked that the vaccine would likely be authorized. “Children, especially the 12- to 15-year-old group, are important to keep in mind, in terms of being at risk for not only getting, but also spreading, COVID-19 infection.”

The initial EUA for the vaccine was granted in December 2020 after a public meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Because the new request involves an amendment to an existing EUA, another meeting of the agency’s vaccine advisory committee isn’t expected.

After the FDA amends the EUA, the vaccine advisory committee of the Centers for Disease Control and Prevention will meet to decide whether to recommend use of the vaccine in 12- to 15-year-olds.

This meeting is likely to happen soon after the FDA’s decision.

Pfizer’s pediatric study is currently enrolling children 6 months to 11 years old. Moderna has an adolescent trial in progress and is recruiting children 6 months to 11 years old for another study.

Although children and teens are less likely to be hospitalized or die from COVID-19, the risk isn’t zero.

“This age group is still at risk of developing long-term symptoms [after coronavirus infection], such as fatigue, headache, and heart problems, which can last weeks to months, according to one study,” said Dr. Christina Mezzone, a pediatrician with Nuvance Health.

“Children and adolescents can also develop multisystem inflammatory syndrome, even after having asymptomatic cases of COVID-19,” she added.

This inflammatory condition, also known as MIS-C, can affect a child’s heart, lungs, kidneys, brain, skin, eyes, and gastrointestinal organs.

In addition, the inability to go to school in person, hang out with friends, play group sports, or do other activities has had other, less direct effects on children’s physical and mental health.

Approval of the Pfizer-BioNTech vaccine for 12- to 15-year-olds “should convince parents and communities to open up all sorts of activities for this age group,” said Dr. Isaac Weisfuse, a medical epidemiologist at Cornell University. “And children will be more likely to have a normal school year in the fall, which is really important.”

Vaccinating children and teenagers is also seen as key to increasing the immunity of the population against the coronavirus and reducing the number of hospitalizations and deaths due to COVID-19.

Although more than 115 million people have been fully vaccinated in the United States, over 40 percent of adults haven’t yet received even one dose.

The greater the number of people vaccinated, the greater the protection for the community. Research suggests that people who are vaccinated are less likely to transmit the virus to others, although scientists continue to study this.

“Children can spread the virus to others,” Weisfuse said. “And we know that there are lots of adults who haven’t gotten the vaccine yet who are at risk.”

Weisfuse said that in particular, vaccinating children who live in multigenerational homes can protect adults in that household, especially those who are not vaccinated or who have weakened immune systems.

In the end, vaccinating more people can help the country come out on the other side.

“The more we vaccinate and protect the population against the coronavirus, the more likely we are to get over the pandemic faster,” said Dr. Steven Abelowitz, a pediatrician and medical director of Coastal Kids.

However, he said that one of the challenges of the Pfizer-BioNTech vaccine is its ultra-cold storage requirements, which limits where it can be distributed.

“Extreme cold storage is a major challenge for community health centers and medical home centers to give out the vaccines,” Abelowitz said. “Parents would be more comfortable if their child’s vaccination was done in the pediatrician’s office, not a pharmacy or stadium.”

With much of the world struggling to vaccinate its high-risk populations, expanding access of the Pfizer-BioNTech vaccine to children and teens in the United States — who have a low risk of severe illness — has already raised some questions.

“The imminent FDA authorization of a vaccine for 12–15 year olds is great news, and adolescents should be able to access vaccine,” Natalie Dean, PhD, assistant professor of biostatistics at the University of Florida, wrote on Twitter. “But in the short term, we must also grapple with the ethics of vaccinating adolescents ahead of high-risk adults in other countries.”

By mid-April, nearly half of the COVID-19 vaccine doses administered had gone to high-income countries, reported The Washington Post.

Johns said it’s important to vaccinate vulnerable populations, not just in the United States but also in other countries. However, she thinks these efforts can happen alongside vaccinating children and teens in this country.

“We know that children are an important component for us getting closer to herd immunity,” she said. “This is a situation where these things should happen in parallel.”

The Kaiser Family Foundation recently outlined actions the U.S. government can take to ensure that all countries have equal access to COVID-19 vaccines.