Adolescents ages 12 to 15 could qualify for a COVID-19 vaccine as soon as Thursday.
On Monday, the U.S. Food and Drug Administration said the vaccine made by Pfizer and its German partner BioNTech is safe and effective enough to give to younger teens under emergency use authorization.
An advisory committee to the Centers for Disease Control and Prevention is scheduled to meet Wednesday to review the recommendation for authorization.
"We know that this is a big step for our country as vaccinating a younger population can bring us closer to a sense of normalcy and to ending this pandemic," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a hearing on Capitol Hill Tuesday.
Pfizer-BioNTech COVID-19 vaccine:FDA authorizes vaccine for younger teens
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Here are some of your top questions on the Pfizer-BioNTech vaccine in younger teens, answered.
Is the Pfizer-BioNTech dose the same as for adults?
Yes. The vaccine is administered as two doses, three weeks apart, with the same dosage as for people ages 16 years and older, according to the FDA.
What safety studies were conducted for the Pfizer-BioNTech vaccine in younger teens?
A study involving 2,260 adolescents 12 to 15 years old found vaccination led to a higher protective antibody response than in adults, and was 100% effective against symptomatic disease. Of the 16 trial participants infected with COVID-19, none had received the vaccine; all had received the placebo.
"Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available scientific data as we have with all of our COVID-19 vaccine authorizations," Marks said Tuesday.
What about the side effects of the Pfizer-BioNTech vaccine?
In the study, side effects in adolescents were consistent with those observed in participants 16 years to 25. The most commonly reported side effects in the adolescent clinical trial participants lasted 1 to 3 days and were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain, according to the FDA.
"With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose," the FDA wrote.
The vaccine should not be given to anyone with a known history of a severe allergic reaction to any component of the vaccine, including anaphylaxis, according to the FDA.
When will Pfizer-BioNTech shots be available to younger teens?
President Joe Biden said last week that 20,000 pharmacy locations are ready to begin vaccinating adolescents once the necessary approvals come through.
Shots also will be available soon through pediatricians' offices, the president said. "And if teens are on the move this summer, they can get their first shot in one place and a second shot elsewhere."
However, FDA officials speaking late Monday said that while their authorization covers the entire country, each state may have its own rules about who can administer vaccines, so not all pharmacies or vaccination sites available to adults will be open to adolescents.
When will Pfizer-BioNTech shots be available for younger children?
In addition to studies of adolescents, Pfizer is running vaccine trials in 5- to 11-year-olds, 2- to 4-year-olds and 6-month-olds to 2-year-olds, but those will take more time to complete and shots are unlikely to be available for younger children before the start of the next school year.
Older teens, ages 16 and 17, have been allowed to get the Pfizer-BioNTech vaccine since it was authorized in December.
The other two vaccines authorized for use in the U.S., from Moderna and Johnson & Johnson, have not been available to minors because studies are still underway.
"I am encouraging all parents to get their children vaccinated. Some parents won't want to be first. But I'm also encouraging children to ask for the vaccine," Dr. Rochelle Walensky, CDC director, said at the hearing Tuesday, adding, "These kids want to go back to school. They want to go back to the things they love."
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