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

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.

By Sharon LaFraniere and Noah Weiland

Oct. 12, 2021

WASHINGTON — Pfizer and BioNTech 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.

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 unvaccinated. 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.

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 Covid,” 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 Covid. 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-BioNTech 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 Moderna and Johnson & Johnson vaccines should receive booster shots, both potentially contentious decisions.

Public health experts have said that the agency’s review of a Pfizer-BioNTech pediatric dose would be closely scrutinized. According to a recent survey conducted by the Kaiser Family Foundation, roughly a third of parents of children between ages 5 and 11 said they would wait and see before allowing their children to receive the shot.

Dr. Walt A. Orenstein, an epidemiologist at Emory University and a former director of the U.S. immunization program, said that given the competing pressures on the F.D.A. to make vaccine decisions quickly but carefully, public discussion was essential.

He said many parents were wavering between fear of Covid-19 and fear of side effects from a pediatric vaccine. If they were less worried about the consequences of coronavirus infection, he said, concerns about possible side effects would be their top priority. If they were more worried, the vaccine’s effectiveness would matter more. As with other vaccines, Dr. Orenstein said, pediatricians would play a critical role in easing parental anxiety.

Pfizer’s clinical trial for children was not intended to draw meaningful conclusions about the vaccine’s ability to prevent disease or hospitalizations. Instead, researchers looked at antibody levels, comparing them with those that had conferred high protection in adults. Regulators are expected to compare the immune responses with vaccine efficacy data in the adult population.

The trial included 2,268 children, two-thirds of whom had received two doses of the vaccine three weeks apart. The remaining volunteers were injected with two doses of a saltwater placebo. Regulators over the summer asked for the trial size to be expanded to 3,000 children.

At a virtual panel on Covid-19 last week, Norman Baylor, the former director of the F.D.A.’s vaccines office, said that the number of participants in Pfizer pediatric study was noticeably small. The adult trial involved about 44,000 people.

“It does beg the question of the size, given what we have for the adults: Would one expect more for the pediatric population?” he said. “They may be thinking, ‘Well, we know the vaccine is safe, because look at how many people we had in the adults.’ But as we know, things may shift in that pediatric population.”

The Pfizer-BioNTech and Moderna vaccines have been tied to increased risks of myocarditis, or inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, particularly in younger men. In August, the F.D.A. published results from an analysis of Pfizer-BioNTech’s vaccine that used a U.S. health care claims database and found that the risk of the conditions in 16- and 17-year-old vaccinated boys could be as high as one in 5,000.

The cases in the database were unconfirmed, but they were considered a reasonable estimate of possible risk, the agency wrote.

A lower dose of the vaccine for children could alleviate those concerns.

Officials in a number of countries have recommended a single dose of the Pfizer-BioNTech vaccine for children 12 and older, which would provide partial protection from the virus but without the potential effects occasionally observed after two doses.

Amy Schoenfeld Walker and Simone Landon contributed reporting.