Pfizer Says Kids 5-11 Should Get Lesser Dose as It Submits COVID Vaccine for FDA Approval

Pfizer announced Thursday that it had submitted its COVID-19 vaccine for children between five and 11 years old to the U.S. Food and Drug Administration for approval, the Associated Press reported. One significant change with the young age group's shot is that it uses lesser doses compared to those given to older populations.

Pfizer said that its research demonstrated that younger kids should be given a third of the dose given to everyone else, the AP reported. Despite the difference in dosage, the younger children were able to develop levels of virus-fighting antibodies that were just as strong and effective as those seen in teens and young adults who received the typical dose of the vaccine.

If regulators approve the vaccine for children, rollout of the shots could begin within weeks, according to the AP. The availability of the vaccine could serve as a huge relief for parents who worried about the safety of children younger than 12 who didn't have the opportunity to get inoculated, but still had to attend school as COVID infections continue to surge across the country.

For more reporting from the Associated Press, see below.

Pfizer Submits Kid Vaccine
Pfizer said that a lesser dose of its COVID-19 vaccine should be used for children 5-11 as it submitted the shot for FDA approval Thursday. A healthcare worker holds a vial of the Pfizer COVID-19 vaccine at Jackson Memorial Hospital in Miami, on Oct. 5, 2021. Lynne Sladky/AP Photo

Pfizer announced in a tweet Thursday that it had formally filed its application with the FDA.

Now the FDA will have to decide if there's enough evidence that the shots are safe and will work for younger children as they do for teens and adults. An independent expert panel will 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

"It makes me very happy that I am helping other kids get the vaccine," said Sebastian Prybol, 8, of Raleigh, North Carolina. He is enrolled in Pfizer's study at Duke University and doesn't yet know if he received the vaccine or dummy 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 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.

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.

To avoid dosing mix-ups, Pfizer is planning to ship vials specially marked for pediatric use containing the lower dose.

Pfizer Seeks Approval for Kid's Vaccine
Pfizer asked the U.S. government Thursday, October 7, 2021, to allow use of its COVID-19 vaccine in children ages 5 to 11 -- and if regulators agree, shots could begin within a matter of weeks. Parents accompany their children outside PS 179 elementary school in the Kensington neighborhood in the Brooklyn borough of New York, on September 29, 2020. Mark Lennihan/AP Photo