WASHINGTON -- Pfizer and BioNTech asked federal regulators 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 Oct. 26 to consider it. A ruling is expected before Thanksgiving.
"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 Thursday.
Parents across the United States are 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.
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Pfizer's announcement came on the same day President Joe 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. 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," Biden said Thursday. "We just have to finish the job."
In the coming weeks, more than 100 million Americans will be subject to vaccine requirements ordered by Biden. And his administration is encouraging employers to take additional steps voluntarily that would push vaccines on people or subject them to testing requirements.
"Look, I know that vaccination requirements are a tough medicine -- unpopular to some, politics for others -- but they're lifesaving, they're game-changing for our country," Biden said.
Biden took that message to a construction site run by Clayco, a large building firm that announced a new vaccinate-or-test requirement for its workforce in conjunction with Biden's visit. The company is taking action weeks before a forthcoming rule by the Occupational Safety and Health Administration that will require all employers with more than 100 employees to require that their staffs be vaccinated or face weekly testing for the coronavirus.
"You're setting an example and a powerful example," Biden told company officials. "I'm calling on more employers to act."
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Biden encouraged other businesses to follow suit by taking action before the OSHA rule and to go even further by requiring shots for their employees without offering a test-out option.
Biden also met with the CEO of United Airlines, Scott Kirby, whose company successfully implemented a vaccine mandate, with no option for workers to be tested instead. Less than 1% have failed to comply and risk termination.
Biden's mandates have "worked spectacularly well," said Lawrence Gostin, a public health expert at Georgetown University's law school. He added that the president's rules have also had a "modeling effect" for cities, states and businesses.
SHOTS FOR KIDS
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 FDA.
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.
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Children rarely become severely ill from covid-19, but the delta variant drove nearly 30,000 of them to 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 children 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 Centers for Disease Control and Prevention. "They die of covid. It's heartbreaking."
About 1 in 6 Americans infected since the beginning of the pandemic was younger than 18. But with the surge of the delta variant, children accounted for as many as 1 in 4 infections last month, according to the American Academy of Pediatrics.
The FDA authorized emergency use of Pfizer's 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 U.S. is 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.
WAIT AND SEE
Public health experts have said that the agency's review of a Pfizer pediatric dose would be closely scrutinized.
"My son asked about playing sports. 'After you're vaccinated.' He asked about seeing his cousins again. 'After you're vaccinated.' A lot of our plans are on hold," said Sarah Staffiere of Waterville, Maine, whose 7-year-old has a rare immune disease that has forced the family to be extra cautious throughout the pandemic.
"When he's vaccinated, it would give our family our lives back," she said.
But there are also plenty of parents who are wary about getting the shot themselves and are in no hurry to have their children vaccinated. 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.
Heather Miller, a mother of four from Dexter, Maine, said she wants to wait for follow-up studies on the vaccine. "I'm not 100% against getting it eventually, but I kind of fall into the 'not right now, wait and see' category," she said.
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 FDA 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, 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 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 FDA 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 1 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.
Information for this article was contributed by Sharon LaFraniere and Noah Weiland of The New York Times; and by Jennifer McDermott, Lauran Neergaard, Emma H. Tobin, Zeke Miller and Aamer Madhani of The Associated Press.
