Pfizer-BioNTech Kids’ Vaccine Gets Closer With FDA Request

Pfizer Inc. and BioNTech SE have submitted an application to U.S. regulators to administer their Covid-19 vaccine to children ages 5 to 11, bringing shots for school-age kids another step closer.

The companies announced the news Thursday in a tweet by Pfizer. The Food and Drug Administration had previously scheduled an advisory committee meeting to review clinical-trial data on the pediatric vaccine for Oct. 26.

Anthony Fauci, President Joe Biden’s top adviser on Covid-19, has suggested that an emergency clearance could come by Halloween. On Thursday, White House Covid response coordinator Jeff Zients said the shots for children could begin before Thanksgiving.

Authorization of the shot for the younger age group would herald a crucial new part of the immunization campaign in the U.S., where the Pfizer vaccine already has full approval for people 16 and older and is authorized on an emergency basis for ages 12 to 15.

Last month, Pfizer and BioNTech said their vaccine was safe and had produced strong antibody responses in children ages 5 to 11 in a trial with 2,268 participants.

Two doses of 10 micrograms, one-third the adult shot, produced antibody levels in school-age kids comparable to those seen in a trial of 16- to 25-year-olds who got the adult dose.

The companies said Sept. 28 that they had submitted initial data from the trial to the FDA and planned to submit a formal application in the coming weeks.

Advisers’ Meeting
Evaluating the safety of the vaccine in younger kids will likely be a key part of the FDA’s review. Other than top-line information included in a statement, Pfizer and BioNTech have released few details of the results from their trial in young children. Full results have not been published in a scientific journal.

The FDA advisers’ meeting for later this month was scheduled in anticipation of the companies’ request for clearance. It will likely be one of the first chances the public has to view the safety profile of the shot in detail. The agency isn’t bound by the advisers’ vote, but if frequently follows their guidance.

Broad clearance for a shot for younger children could help reduce concerns about the spread of the coronavirus in schools. The surge in new cases fueled by the delta variant has disrupted classrooms across the U.S., leading to quarantines and concern about transmission.

Many parents have expressed eagerness to vaccinate their children. Even so, the FDA will take a careful look at the vaccine’s safety in younger kids.

While kids get infected frequently and can help spread the virus, they are at much lower risk of developing severe complications than older adults. In rare cases, messenger RNA vaccines have been linked to heart inflammation and heart-lining inflammation, and the risk appears to be higher in young males.