Pfizer and BioNTech have asked the FDA to authorize their vaccine for Covid-19 for children aged 5 to 11
Teachers give a lesson to their masked students in their classroom in New York City. | Michael Loccisano/Getty ImagesPfizer and BioNTech have asked the Food and Drug Administration to authorize their vaccine for Covid-19 for children aged 5 to 11, the companies announced Thursday.
The FDA took the unusual step of scheduling a meeting of its external vaccine advisory committee to discuss the Pfizer-BioNTech shot for children before the companies had formally sought authorization. At that meeting, on Oct. 26, panel members will vote on whether to recommend the shot for kids 5-11. FDA is not bound by the panel's advice but usually takes it. The agency could act within days after the meeting.In late September, the companies said their Covid-19 vaccine provoked a strong antibody response in children in a late-stage clinical trial.
Pfizer and BioNTech continue to gather safety and efficacy data on their Covid-19 shot for younger children aged 6 months to 4 years old. They’ve said they expect to release basic information “as soon as” this quarter.
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