The agency stated that its scientists determined the booster’s benefits, including bolstering protection against virus infection, outweigh its potential risks in the population.
Reviewers analyzed data from Israel, one of the most vaccinated countries in the world, to reach the conclusion.
The dataset from Israel included information on more than 6,300 children 12 through 15 who have received a booster dose.
“The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals,” the FDA said in a statement.
Myocarditis and pericarditis are two forms of heart inflammation seen at much higher than expected rates among young people, particularly young men, following vaccination with the Pfizer or Moderna COVID-19 vaccines.
The risk of heart inflammation is actually higher from the vaccines than from COVID-19 itself in young persons, according to some studies.
One study published last month found post-booster inflammation was more prevalent than post-COVID inflammation.
The FDA didn’t immediately post any documents about its decision, which came without consulting its expert vaccine advisory panel.
The agency also bypassed the panel in authorizing boosters for 16- and 17-year-olds, and all 18 and older, drawing criticism from some panel members and former FDA officials.
Dr. Paul Offit, a member of the panel, noted on Jan. 3 that members in September 2021 rejected a push by the Biden administration to make boosters available for all 16 and older.
“The reason we said no was we didn’t see the need, a clear benefit, and because myocarditis is always risk in a younger male age group,” he told The Epoch Times.
The vaccine’s primary series is largely holding up well against severe disease even as it wanes considerably against infection, Offit noted, which can be confusing.
“People would think, ‘I’m not going to be protected against this disease at all unless I get a third dose.’ And that’s certainly not what people are seeing in hospitals,” added Offit, who said most pediatric cases at the Children’s Hospital of Philadelphia, where he works, are unvaccinated.
The FDA and booster supporters say additional shots will help restore protection against infection that’s waned against the Omicron variant of the CCP (Chinese Communist Party) virus, which causes COVID-19.
Critics, though, note that Omicron manifests with zero or few symptoms for most who contract it, especially young, healthy people.
The Centers for Disease Control and Prevention will now take up the authorization and choose whether to recommend boosters to all 12- to 15-year-olds or just certain persons in the population.
The agency is expected to consult its advisory panel, ACIP, before making the decision.
Dr. Stanley Perlman, a microbiology professor at the University of Iowa and member of the panel, supports the FDA clearance.
“I think that approval of boosters for use in 12-15-year-old adolescents is appropriate, given the high transmissibility of the Omicron variant and the waning of antibody titer that occurs,” Perlman told The Epoch Times in an email.
“This population may well be protected against severe disease so it will be important to hear what the ACIP has to say.”
Also on Jan. 3, the FDA stated that children aged 5 to 11 who are deemed immunocompromised can get a booster shot of Pfizer’s vaccine.
Unlike older Americans, who must wait at least five months until after their primary series, the youngest age group can get a booster as soon as one month later.
“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants. In particular, the Omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
“With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”