Pfizer and BioNTech have submitted data collected during a trial of its coronavirus vaccine in children ages 5 to 11 to the U.S. Food and Drug Administration, the companies announced Tuesday morning.
In a news release, the companies said they shared the data collected during their Phase 2 and 3 trials with the FDA for an “initial review.” A formal submission to request emergency use authorization “is expected to follow in the coming weeks,” the release said.
The news came just over a week after the drugmakers said early data from the trial showed “a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age” who received two doses of the Pfizer-BioNTech coronavirus vaccine.
The study’s nearly 2,300 participants received smaller doses of the vaccine than adults but got the shots at the same 21-day interval used for other age groups, a Sept. 20 news release said. Even so, elementary-age children developed antibody levels comparable to those of 16- to 25-year-olds, the companies said. The vaccine also was “well-tolerated” in the elementary age group, with the children reporting comparable side effects to the adults, according to the earlier release.
Although the study has not yet been peer-reviewed, the companies plan “to submit data from the full Phase 3 trial” to a scientific publication, the drugmakers said Tuesday.
Following Tuesday’s announcement, infectious disease expert Dr. Anthony Fauci told MSNBC that he’s hopeful the FDA will examine the data and approve the shot for the elementary age group before the end of October. Readouts for children from 6 months to 5 years old will be available “as soon as the fourth quarter of this year,” Pfizer and BioNTech said Tuesday.
The Pfizer-BioNTech vaccine already has received full FDA approval for residents ages 16 and up, and it is authorized for emergency use in 12- to 15-year-olds. Two other COVID-19 vaccines – one made by Moderna and another by Johnson & Johnson – have been approved for emergency use in people ages 18 and up.
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