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FDA advisory panel reviews Pfizer’s COVID vaccine for kids ages 5-11

This October 2021 photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. (Pfizer via AP)
This October 2021 photo provided by Pfizer shows kid-size doses of its COVID-19 vaccine in Puurs, Belgium. (Pfizer via AP)

WASHINGTON — Kid-size doses of Pfizer’s COVID-19 vaccine may be getting closer as government advisers begin deliberating today whether there’s enough evidence that the shots are safe and effective for 5- to 11-year-olds.

A study of elementary schoolchildren found the Pfizer shots are nearly 91% effective at preventing symptomatic infection — even though the youngsters received just a third of the dose given to teens and adults.

In a preliminary analysis last week, Food and Drug Administration reviewers said that protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic. Now FDA’s advisers are combing through that data to see if they agree.

If the FDA authorizes the kid-size doses, there’s still another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.

While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including over 8,300 hospitalizations, about a third requiring intensive care, and nearly 100 deaths, FDA vaccine chief Dr. Peter Marks tells the advisory panel.

Also, “infections have caused many school closures and disrupted the education and socialization of children,” he says.

“I want to acknowledge the fact that there are strong feelings” among the public for and against child vaccinations, Marks adds, noting that the discussion would be on scientific data “not about vaccine mandates, which are left to other entities outside of FDA.”

Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older but pediatricians and many parents are clamoring for protection for younger children. The extra-contagious Delta variant has caused an alarming rise in pediatric infections — and families are frustrated with school quarantines and having to say no to sleepovers and other rites of childhood to keep the virus at bay.

States are getting ready to roll out shots for little arms — in special orange-capped vials to distinguish them from adult vaccine — as soon as the government gives the OK. More than 25,000 pediatricians and other primary care providers have signed up so far to offer vaccination.

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