FDA authorizes Pfizer COVID-19 vaccine for kids ages 12 to 15

The U.S. Food and Drug Administration on Monday expanded emergency use authorization for Pfizer-BioNTech’s COVID-19 vaccine in the United States for older children ages 12 to 15.

Last month, Pfizer said Phase 3 clinical trials found its COVID-19 vaccine was safe and 100% effective among this age group. The preliminary data showed there were no cases among the fully vaccinated adolescents compared to 18 among those given placebo shots.

The study involved 2,260 U.S. volunteers ages 12 to 15 and has not yet been peer-reviewed.

Overall, kids develop a serious illness or die from COVID-19 at much lower rates than adults, but they do still get sick and can spread the virus.

Children make up roughly 13% of COVID-19 cases that have been documented in the country, according to officials. At least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to figures shared by the American Academy of Pediatrics.

"Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older," the FDA wrote in a press release on Monday.

Meanwhile, Moderna announced last week that data from an ongoing trial of its COVID-19 vaccine for teens ages 12-17 was 96% effective against the novel coronavirus. 

No additional side effects or serious safety concerns were reported so far, according to the company. 

Moderna’s ongoing trial consists of 3,235 teenagers, and efficacy for the vaccine was approximately 96% for the participants who received at least one injection, Moderna reported. The company also said that because incidence rate of COVID-19 is lower in adolescents and teenagers, the vaccine’s effectiveness on the trial patients is mainly against milder symptoms of the disease. 

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The company said the majority of adverse effects of the teen vaccine were mild or moderate in severity. The most common adverse effect was pain at the injection site.

Vaccinating children of all ages will be critical to a return to normalcy. Most COVID-19 vaccines rolling out worldwide have been authorized for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up. Parents, school administrators and public health officials elsewhere are anxiously awaiting the shot to become available to more kids.

"This is a watershed moment in our ability to fight back the COVID-19 pandemic," Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press.

The Food and Drug Administration declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The study found no cases of COVID-19 among fully vaccinated adolescents compared to 18 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.

The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.

Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.

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Next up is testing whether the vaccine works for even younger children. Both Pfizer and Moderna have begun U.S. studies in children ages 6 months to 11 years. Those studies explore whether babies, preschoolers and elementary-age kids will need different doses than teens and adults. Gruber said Pfizer expects its first results sometime in the fall.

Outside of the U.S., AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as 3.
Children are far less likely than adults to get seriously ill from COVID-19 yet they still have been hard-hit by the pandemic.

"Children right now are struggling," Gruber said. Plus, "we need as many people in the country who have the potential to transmit the virus to be protected."

Experts say children must get the shots if the country is to vaccinate the 70% to 85% of the population necessary to reach what’s called herd immunity.

In the meantime, the Centers for Disease Control and Prevention says unvaccinated people -- including children -- should continue taking precautions such as wearing masks indoors and keeping their distance from other unvaccinated people outside of their households.

This story was reported from Los Angeles. Kelly Hayes and The Associated Press contributed.