The study involved nearly 2,300 children in that age range -- many of whom received two doses of the vaccine three weeks apart. The others received placebo doses.
The dose given to the younger children, 10 micrograms, is a third of the amount given to adults and children 12 to 16 years old. Pfizer said the smaller dose would minimize side effects but still activate a strong immune response.
Pfizer's vaccine is already being administered in children 12 to 16 years old. If its lower dose is approved, the vaccine would be the first to be authorized for children as young as 5. File Photo by John Angelillo/UPI
"Two primary doses of the vaccine given three weeks apart in 5 to 11 years of age have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern and high [effectiveness] against symptomatic COVID-19 in a period where the Delta variant was predominant," Pfizer's 82-page report said.
"Given all the [data], the benefits of the Pfizer-BioNTech COVID-19 vaccine ... in children 5 to 11 years of age outweigh the known or potential risks."
The FDA was expected to post an independent review of the Pfizer data later Friday.
The agency's Vaccines and Related Biological Products Advisory Committee will meet on Tuesday to weigh including children 5-11 in its emergency use authorization for Pfizer's coronavirus vaccine.
If the panel approves lower doses for younger children, the FDA and Centers for Disease Control and Prevention would also need to sign off on them. If that happens, children in the lower age range could begin to receive the vaccine next month.
The data showed that the antibody response in children with the lower dosage were comparable to the immune response seen in adults who'd received the vaccine.
Pfizer's vaccine is already being administered in children 12 to 16 years old. If its lower dose is approved, the vaccine would be the first to be authorized for children as young as 5.