The U.S. Food and Drug Administration on Monday approved the use of the Pfizer-BioNTech COVID-19 vaccine for adolescents ages 12 to 15, paving the way for the use of the drug in adolescents as early as this week.
“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,” acting FDA Commissioner Janet Woodcock said in a statement Monday.
“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,” Woodcock said.
Monday’s decision by the FDA will be followed by a Wednesday meeting of the Centers for Disease Control and Prevention’s vaccine advisory committee. The committee will meet to decide how the vaccine should be used in that age group.
The vaccine can be administered as soon as the CDC director signs off on the recommendation.
Here’s is what we know now about the vaccine for 12- to 15-year-olds.
When will 12- to 15-year-olds be able to get the vaccine?
Providers could be giving the vaccine as early as Thursday, but the decision on who is eligible for the two-dose regimen is made by each state.
“I would be surprised if it were more than a week or two before kids start getting shots, and in theory, once the emergency use authorization is given, kids could get vaccinated the very next day,” pediatrician Robert Frenck, director of the Center For Vaccine Research at Cincinnati Children’s Hospital, told The Wall Street Journal.
Cincinnati Children’s Hospital helped test the Pfizer-BioNTech shot in adolescents.
According to the Journal, timing of the shots depends on factors including when states make 12- to 15-year olds eligible for the vaccine, and the number of shots a state has available.
According to a press conference held by President Joe Biden last week, 20,000 pharmacy locations, as well as pediatricians’ offices, will be ready to begin vaccinating the 12- to 15-year olds.
“Parents and their children can talk to their family doctor about it and get their shot from a provider they trust the most. Easy, fast and free,” Biden said. “And if teens are on the move this summer, they can get their first shot in one place and the second shot elsewhere.”
What about risks and side effects?
While any vaccine can be risky, the research from Pfizer has shown that the COVID-19 vaccine poses no different risks to children in the 12-15 age group than it does to those 16 to 25 years old.
As for side effects, the same holds true. A sore arm, fever, muscle aches and chills have been reported by adults who have had the vaccine, as well as by the adolescents in Pfizer’s trial studies. According to Pfizer, the vaccine was “well tolerated” in its trials of adolescents, with side effects “generally consistent with those observed in participants 16 to 25 years of age.”
In very rare cases, some in both Pfizer’s trials and those of Moderna, which also makes a COVID-19 vaccine, experienced severe allergic reactions.
The trial enrolled 2,260 participants. Of that number, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group.
Dr. Megan Ranney, an emergency room physician and professor at Brown University in Providence, Rhode Island, told The New York Times she had “zero safety concerns” about the Pfizer-BioNTech vaccine, noting that hundreds of millions of people worldwide had received it.
“The risk of your child catching COVID and getting really sick is low, but it’s not zero,” Ranney said. “And the risk of them getting sick or hospitalized or worse with COVID or with the post-COVID multi-inflammatory syndrome is higher than the risk of something bad from this vaccine.”
Around 1.5 million of those ages 11-17 were diagnosed with COVID-19 from March 1, 2020, to April 30, 2021, according to the CDC.
When will younger children be vaccinated?
Pfizer is now conducting trials involving children ages six months to 11 years old, and the company’s chairman and CEO Albert Bourla said on a quarterly earnings call last week that he expects to request an emergency use authorization (EUA) from the FDA in September.
If that authorization is granted, an EUA request for ages six months to 2 years would follow before the end of the year.
Will adolescents have to be vaccinated to get into school in the fall?
It is unlikely that a COVID-19 vaccine will be required to get into school this next school year, Dorit Reiss, a law professor focused on vaccine policy at the University of California Hastings College of Law, told The Washington Post.
Reiss said a decision on a requirement for a COVID-19 vaccine is likely to come after the vaccines win full approval from the FDA.
Cox Media Group