The U.S. Food and Drug Administration (FDA) on Monday authorized a booster shot of Pfizer’s COVID-19 vaccine for children 12 to 15. 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 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.


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 CDC 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 on the decision, which came without consulting its expert advisory panel.


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.”

No comments:

Post a Comment