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

Coronavirus

WASHINGTON — 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.

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.

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.

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.

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.

Pfizer’s study tracked 2,268 children ages 5 to 11 who got two shots three weeks apart of either a placebo or the kid dose. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots.

And so far, 16 kids given dummy shots developed symptomatic COVID-19 compared to three vaccinated youngsters, meaning the vaccine was nearly 91% effective. Most of the study data was collected in the U.S. during August and September as the delta variant surged.

The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience. At FDA’s request, Pfizer more recently enrolled another 2,300 youngsters into the study, and preliminary safety data has shown no red flags.

The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men and teen boys.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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