(AP) – Pfizer asked the US government on Thursday to allow use of its COVID-19 vaccine in children ages 5 to 11. If regulators agree, the administration of shots could begin within a matter of weeks.
Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration (FDA). The FDA will now have to decide if there’s enough evidence that the shots are safe and will work for younger children like they do for teens and adults.
Pfizer says its research shows the younger kids should get a third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as teens and young adults get from regular-strength shots.
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11, and has said there were no serious side effects. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine, mostly in young men.
An independent expert panel is expected to publicly debate the evidence on October 26.
While kids are at lower risk of severe illness or death than older people, COVID-19 does sometimes kill children and cases in youngsters have skyrocketed as the extra-contagious delta variant has swept through the country.
If the FDA authorizes emergency use of the kid-sized doses, there’s another hurdle before vaccinations in this age group can begin. Advisers to the Centers for Disease Control and Prevention will decide whether to recommend the shots for youngsters, and the CDC will make a final decision.