The shots for kids may not be reviewed until April.
August Mascitti, 9, puts a sticker on his mask after becoming one of the first kids in the Lehigh Valley to get his coronavirus shot.COVID-19 vaccinations for children under 5 hit another delay Friday as U.S. regulators abruptly put the brakes on their efforts to speed review of the shots that Pfizer is testing for youngsters.
FDA’s vaccine chief Dr. Peter Marks said he hoped parents would understand that the agency’s decision was part of its careful scientific review of the evidence Pfizer has submitted so far. Vaccine experts had been concerned with the sudden race to evaluate Pfizer’s vaccine -- and now wonder what parents will make of the back-and-forth.
It’s not the first delay. Pfizer originally had expected to know by late December if the extra-low doses worked for kids under 5 — only to face a disappointing setback. Preliminary study results showed two shots were safe and strong enough to give good protection to babies as young as 6 months. But once tots reached the preschool age — the 2- to 4-year-olds — two doses weren’t protective enough, prompting the addition of a third to the study.
Earlier this week, FDA’s Marks had promised the agency wouldn’t cut corners but also noted how rapidly the pandemic was changing. Before Thanksgiving, no one had heard of omicron, by last month pediatric COVID-19 infections had hit an all-time high — and now cases are dropping fast as the latest mutant burns out.
A Kaiser Family Foundation poll taken last month found just 3 in 10 parents of children under 5 would get their youngster vaccinated as soon as shots were authorized, while about a quarter said they definitely would not.
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