Pfizer asks US to allow COVID shots for kids ages 5 to 11
Pfizer is asking the U.S. government to allow use of its COVID-19 vaccine in children ages 5 to 11. If regulators agree, shots could begin within a matter of weeks. Pfizer already had announced that a lower dose of its vaccine worked and appeared safe in a study of the youngsters.
Pfizer and its German partner BioNTech on Thursday officially filed its application with the Food and Drug Administration.
FDA’s advisers are scheduled to debate the evidence later this month. Until now the vaccine was available only as young as 12, and many parents and pediatricians are clamoring for protection for younger kids.
Many parents and pediatricians are clamoring for protection for children younger than 12. Not only can youngsters sometimes get seriously ill but keeping them in school can be a challenge with the coronavirus still raging in poorly vaccinated communities.
"It makes me very happy that I am helping other kids get the vaccine," says eight-year-old Sebastian Prybol, who is enrolled in the Pfizer clinical trial for 5 to 11-year-olds. "And like, honestly, if I had to get the shot again, I would. Honestly, I would."
Now the FDA will have to decide if there’s enough evidence that the shots will work for younger children like they do for teens and adults.
"We do want to make sure that it is absolutely safe for them," says Britni Prybol, Sebastian’s mother. But she will be "overjoyed" when FDA approval happens.
Advisers to the FDA will publicly deliberate Pfizer’s vaccine in the 5 to 11 age group group on Oct. 26, setting the stage for the FDA to declare if the shots are safe and effective for those youngsters.