Pfizer 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 filing could clear the way for roughly 28 million children in the United States to be vaccinated against the virus, beginning in a matter of weeks. 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.
Background: In late September, the companies said their Covid-19 vaccine provoked a strong antibody response in children in a late-stage clinical trial. Though children were given a smaller dose of the shot, their immune responses were comparable to those of teenagers and younger adults who got a much larger dose.
These data have not yet been published in a peer-reviewed scientific journal.
What’s next: The FDA vaccine advisory committee is set to meet on Oct. 26.
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.