FDA advisers review Pfizer’s COVID-19 vaccine for kids
WASHINGTON (AP) — Kid-size doses of Pfizer’s COVID-19 vaccine may be getting closer as government advisers on Tuesday began deliberating 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 told the advisory panel.
Also, "infections have caused many school closures and disrupted the education and socialization of children,” he said.
“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.”
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...
