Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

The agency has promised to move quickly on the request and tentatively plans to meet on Oct. 26 to consider it. A decision could come soon after Halloween.

A 9-year-old receiving a second dose of the Pfizer-Biotech coronavirus vaccine in a clinical trial for children in Durham, N.C., in April.
A 9-year-old receiving a second dose of the Pfizer-Biotech coronavirus vaccine in a clinical trial for children in Durham, N.C., in April.Credit…Shawn Rocco/Duke Health, via Reuters
Sharon Lavaliere Noah Welland

By Sharon Lavaliere and Noah Welland
Published Oct. 7, 2021Updated Oct. 12, 2021, 8:56 a.m. ET

WASHINGTON — Pfizer and Biotech asked federal regulators on Thursday to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States.

The companies say they are submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. An F.D.A. ruling is expected as early as Halloween.

A meeting of expert advisers to the Centers for Disease Control and Prevention has been scheduled for Nov. 2 and 3, according to people familiar with the planning. The C.D.C.’s recommendations are typically the federal government’s last word on vaccine policy.

“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 on Thursday.

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Parents across the United States are anxiously awaiting the regulators’ decision, which could affect many aspects of family life and the operation of schools. Clearance depends not only on the strength of the clinical trial data, but also on whether the companies can prove to regulators that they are able to properly manufacture a new pediatric formulation.

Pfizer’s announcement came on the same day President Biden visited Illinois to encourage employers to impose vaccine requirements, part of a broader effort by the White House to reach the tens of millions of Americans who remain vaccinated. Mr. Biden last month announced he would mandate vaccination or weekly testing for workers at companies with more than 100 employees.

“We have the tools, we’re using them, and we’re making progress,” Mr. Biden said on Thursday. “We just have to finish the job.”

Shots for children represent another critical phase of the administration’s vaccination campaign, potentially allowing schools, workplaces and other venues to operate with fewer disruptions as the pandemic persists.

Pfizer has proposed giving children one-third of the adult dosage. Depending on what formulation Pfizer produces pediatric doses in, that might require adding a different amount of diluent to each injection or using a different vial or syringe. The company was expected to describe the method it intended to use in its submission to the F.D.A.
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Regulators will have to examine the purity and stability of mass-manufactured doses of the vaccine and determine that it matches the quality and potency of doses given to children in clinical trials.

Children rarely become severely ill from Covid-19, but the Delta variant landed nearly 30,000 of them in hospitals in August. According to the American Academy of Pediatrics, nearly 5.9 million Americans younger than 18 have been infected with the coronavirus. Of the roughly 500 Americans under 18 who have died, about 125 were ages 5 to 11.

“It really bothers me when people say kids don’t die of Ovid,” said Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Health who also leads a key advisory committee to the C.D.C. “They die of Ovid. It’s heartbreaking.”

About one in six Americans infected since the beginning of the pandemic was under 18. But with the surge of the Delta variant, children accounted for as many as one in four infections last month, according to the American Academy of Pediatrics.

The F.D.A. authorized emergency use of the Pfizer-Biotech vaccine for 12- to 15-year-olds in May. Since then, more than 8.2 million children in that age group have received at least one dose, and more than 6.7 million have been fully vaccinated.

The infection rate in the United States is currently falling, prompting hope that the wave caused by the Delta variant is ebbing. But public health experts worry that the onset of colder weather could result in increased transmission.

Although federal regulators are under enormous pressure to quickly review Pfizer’s application, they also face other pressing decisions. Next week, they might rule on whether people who received the Moderns and Johnson & Johnson vaccines should receive booster shots, both potentially contentious decisions.

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