FDA Committee Approves Pfizer Vaccine for Kids Aged 5-11
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The Food and Drug Administration on Friday approved Pfizer-BioNTech’s Covid-19 vaccine for use in children, a long-awaited move that followed its approval by a smaller panel on Wednesday.
The approval clears the vaccine for distribution to about 28 million Americans in the 5-11 age range. Pfizer, which conducted a trial over the summer involving 2,268 participants, said its research found the vaccine had an efficacy rate of 90.7 percent among those in the group. But the number was not large enough to gage the risk of side effects including myocarditis and pericarditis, or inflammation of the heart that occurs in some adults after the vaccine’s second dose.
“The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with Pfizer-BioNTech Covid-19 Vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age,” the FDA noted in its assessment of the vaccine.
The agency said it conducted its own modeling to estimate how many children might avoid “symptomatic Covid-19 cases, hospitalizations, intensive care unit admissions and deaths” if they took the vaccine “versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths” that the vaccine might cause, but did not elaborate on the results. “The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11 years of age,” the agency said.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” acting FDA Commissioner Janet Woodcock said in a statement following the decision.
CDC research this year suggested Covid-19 antibodies were already present in up to 42 percent of children in the 5-11 group. Moderna said this week it would also soon seek approval for distributing its vaccine to children, claiming research found it 1.5 times more effective in those aged 6-11 than in adults.
