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.
While children are at lower risk of severe COVID-19 than older people, ultimately many panelists decided it’s important to give parents the choice to protect their youngsters — especially those at high risk of illness or who live in places where other precautions, such as masks in schools, aren’t being used.
The virus is “not going away. We have to find a way to live with it, and I think the vaccines give us a way to do that,” said FDA adviser Jeannette Lee of the University of Arkansas.
“I do think it’s a relatively close call,” said adviser Dr. Eric Rubin of Harvard University. “It’s really going to be a question of what the prevailing conditions are, but we’re never going to learn about how safe this vaccine is unless we start giving it.”
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 more than 8,300 hospitalizations reported, about one-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.
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.
»Sign up for our coronavirus newsletter
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.
About the Author
