FDA advisers back Pfizer’s COVID-19 vaccine for kids

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days

A panel of U.S. health advisers on Tuesday endorsed kid-size doses of Pfizer’s COVID-19 vaccine, moving the U.S. closer to beginning vaccinations in children ages 5 to 11.

A Food and Drug Administration advisory panel voted unanimously with one abstention that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks — including a heart-related side effect that’s been very rare in teens and young adults who get a much higher dose.

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The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days.

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.

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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 reported, about a third requiring intensive care, and nearly 100 deaths.

The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older. Moderna also is studying its vaccine for young children.

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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.

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