Pfizer asked the FDA Thursday to authorize emergency use of the COVID-19 vaccine for children ages 5 to 11.
The company says they are submitting data supporting the change to the FDA, which has promised to move quickly on the request and has tentatively scheduled a meeting on October 26 to consider it, the New York Times reports.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid-19,” Pfizer said Thursday.
Authorization depends on the strength of the clinical trial data, as well as whether the company can prove they are able to properly manufacture a new pediatric formula.
Pfizer has proposed giving children one-third of the dose adults receive, which might require adding more diluent to each injection or using a different syringe.
Pfizer’s clinical trial for children looked at antibody levels, comparing them with adult levels. Indeed, the trial included 2,268 children. Two-thirds of them received two doses of the vaccine three weeks apart, while the remaining were injected with a saltwater placebo.
Regulators are expected to compare the responses between children and adults.
