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.
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.