Pfizer asked the U.S. government Thursday to allow use of its COVID-19 vaccine in children ages 5 to 11 — and, if regulators agree, shots could begin within weeks.
Many parents and pediatricians are clamoring for protection for kids younger than 12, which has been the age cutoff for the vaccine made by Pfizer and its German partner BioNTech. Not only can kids sometimes get seriously ill, keeping them in school can be a challenge with the coronavirus still raging in poorly vaccinated communities.
Pfizer announced in a tweet that it formally filed its application with the federal Food and Drug Administration.
Now, the FDA must decide whether there’s enough evidence that the shots are safe and will work for younger children like they do for teenagers and adults. An independent expert panel will publicly debate the evidence on Oct. 26.
One big change: Pfizer says its research shows the younger kids should get just one-third of the dose that’s now given to everyone else.
After getting their second shot, the 5- to 11-year-olds who were tested developed virus-fighting antibody levels just as strong as teenagers and young adults get from regular-strength shots, according to the drugmaker.
While kids are at lower risk of severe illness or death than older people, COVID does sometimes kill children. And the number of cases among kids hse skyrocketed as the extra-contagious Delta variant has swept the country
“It makes me very happy that I am helping other kids get the vaccine,” said Sebastian Prybol, 8, of Raleigh, North Carolina, who is enrolled in Pfizer’s study at Duke University and doesn’t yet know whether received the vaccine or placebo shots.
“We do want to make sure that it is absolutely safe for them,” said Sebastian’s mother Britni Prybol. But she said she will be “overjoyed” if the FDA clears the vaccine.
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11 and 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.
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 federal Centers for Disease Control and Prevention will decide whether to recommend the shots for this age group, with the CDC making the final decision.