Public health experts have said that the agency’s review of a Pfizer-BioNTech pediatric dose would be closely scrutinized. According to a recent survey conducted by the Kaiser Family Foundation, roughly a third of parents of children between ages 5 and 11 said they would wait and see before allowing their children to receive the shot.
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Dr. Walt A. Orenstein, an epidemiologist at Emory University and a former director of the U.S. immunization program, said that given the competing pressures on the F.D.A. to make vaccine decisions quickly but carefully, public discussion was essential.
He said many parents were wavering between fear of Covid-19 and fear of side effects from a pediatric vaccine. If they were less worried about the consequences of coronavirus infection, he said, concerns about possible side effects would be their top priority. If they were more worried, the vaccine’s effectiveness would matter more. As with other vaccines, Dr. Orenstein said, pediatricians would play a critical role in easing parental anxiety.
Pfizer’s clinical trial for children was not intended to draw meaningful conclusions about the vaccine’s ability to prevent disease or hospitalizations. Instead, researchers looked at antibody levels, comparing them with those that had conferred high protection in adults. Regulators are expected to compare the immune responses with vaccine efficacy data in the adult population.
The trial included 2,268 children, two-thirds of whom had received two doses of the vaccine three weeks apart. The remaining volunteers were injected with two doses of a saltwater placebo. Regulators over the summer asked for the trial size to be expanded to 3,000 children.
At a virtual panel on Covid-19 last week, Norman Baylor, the former director of the F.D.A.’s vaccines office, said that the number of participants in Pfizer pediatric study was noticeably small. The adult trial involved about 44,000 people.
“It does beg the question of the size, given what we have for the adults: Would one expect more for the pediatric population?” he said. “They may be thinking, ‘Well, we know the vaccine is safe, because look at how many people we had in the adults.’ But as we know, things may shift in that pediatric population.”
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