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NEWS & ANALYSIS

Pfizer Requests FDA Vaccine Authorization for Children 5 to 11


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.