FDA advisors review Pfizer’s COVID-19 vaccine for younger kids

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U.S. health advisors are debating whether kid-size doses of Pfizer's COVID-19 vaccine are safe and effective in young children ages 5 to 11.

Kid-size doses of the COVID-19 vaccine made by Pfizer and BioNTech may be getting closer as government advisors on Tuesday began deliberating whether there’s enough evidence that the shots are safe and effective for children ages 5 to 11.

A study of elementary schoolchildren found the Pfizer shots were nearly 91% effective at preventing coronavirus infections with COVID-19 symptoms — even though the youngsters received just a third of the dose given to teens and adults. In a preliminary analysis last week, reviewers at the Food and Drug Administration said that protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic. Now members of the FDA’s scientific advisory panel are combing through the data to see if they agree.

If the FDA authorizes the kid-size doses, there are still more steps ahead: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots, and if so, which youngsters should get them.Although children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness — including more than 8,300 hospitalizations.

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

 

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