Article by Zachary Stieber from our premium news partners at The Epoch Times.
The agency said 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 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 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.
The FDA did not post any documents yet on the 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.
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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.
Also on Monday, the agency said 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,” he added.
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