Pfizer asks FDA to clear its Covid-19 vaccine for children aged 5 to 11

WASHINGTON – Pfizer and BioNTech said Thursday morning they had asked federal regulators to allow emergency use of their coronavirus vaccine for children aged 5 to 11, a move that could help protect more than 28 million people in the United States.

The companies said they were submitting data in support of the change to the Food and Drug Administration. The agency has vowed to act quickly on the request and tentatively scheduled a meeting on October 26 to consider it. A decision is expected between Halloween and Thanksgiving.

Parents across the United States are anxiously awaiting the decision of regulators, which could affect family life and the functioning of schools. Authorization depends not only on the strength of the clinical trial data, but also on their ability to prove to regulators that they are capable of properly manufacturing a new pediatric formulation.

FDA Acting Commissioner Dr Janet Woodcock said last week that children may need “a different strength or formulation than that used in an older pediatric population or in adults.”

Pfizer has proposed giving children one-third of the adult dose. This may require adding more diluent with each injection or using a different vial or syringe. The company was to describe the method it intended to use in its submission to the Food and Drug Administration.

Regulators will need to examine the purity and stability of mass produced vaccine doses and determine that they are consistent with the quality and potency of doses given to children in clinical trials. A pediatric dose will also most likely require re-labeling, with special codes that would allow the Centers for Disease Control and Prevention to track specific batches if serious side effects are reported.

Children rarely get seriously ill from Covid-19, but the Delta variant took nearly 30,000 of them to hospital in August. According to the American Academy of Pediatrics, nearly 5.9 million Americans under the age of 18 have been infected with the coronavirus. Of the roughly 500 Americans under the age of 18 who died, about 125 were children between the ages of 5 and 11.

“It really bothers me when people say kids don’t die from Covid,” said Dr Grace Lee, deputy chief medical officer at Stanford Children’s Health who also heads a key advisory committee to the CDC. “They die from Covid. It is heartbreaking.

About one in six Americans infected since the start of the pandemic was under the age of 18. But with the Delta variant soaring, children accounted for up to one in four infections last month, according to the American Academy of Pediatrics. The Food and Drug Administration authorized emergency use of Pfizer’s vaccine for 12 to 15 year olds in May.

The infection rate in the United States is currently on the decline, giving hope that the Delta variant is fading. But public health experts fear the onset of colder weather could lead to increased transmission.

While federal regulators are under enormous pressure to swiftly review Pfizer’s claim, they are also faced with other urgent decisions. Next week, they could decide whether people who received the Moderna and Johnson & Johnson coronavirus vaccines should receive booster shots, two potentially contentious decisions.

Public health experts have said the agency’s review of a pediatric dose of Pfizer will be closely watched. According to a recent survey conducted by the Kaiser Family Foundation, about a third of parents of children aged 5 to 11 said they would wait and see before allowing their children to receive such an injection.

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

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

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

The trial included 2,268 children, two-thirds of whom received two doses of the vaccine three weeks apart. The other volunteers were injected with two doses of saltwater placebo. Over the summer, regulators called for the trial size to be expanded to 3,000 children.

During a virtual panel on Covid-19 last week, Norman Baylor, the former director of the Food and Drug Administration’s office of vaccines, said the number of participants in the Pfizerpediatric study was noticeably low. The adult trial involved approximately 44,000 people.

“This raises the question of size, given what we have for adults: would we expect more for the pediatric population? ” he said. “They might think, ‘Well, we know the vaccine is safe, because look at how many people we’ve had in adults. But as we know, things can change in this pediatric population. “

The Pfizer-BioNTech and Moderna vaccines have been linked to increased risks of myocarditis or inflammation of the heart muscle; and pericarditis, inflammation of the lining around the heart, especially in younger men. In August, the Food and Drug Administration released the results of an analysis of the Pfizer-BioNTech vaccine that used a U.S. health care claims database and found that the risk of disease in vaccinated boys from 16 and 17 years old could be as high as 1 in 5,000.

The cases in the database were not confirmed, but they were considered a reasonable estimate of possible risk, the agency wrote.

A lower dose of the vaccine for children may alleviate these concerns.

Authorities in several countries have recommended a single dose of Pfizer-BioNTech vaccine for children 12 years of age and older, which would provide partial protection against the virus, but without the potential effects seen occasionally after two doses. Sweden and Denmark joined the countries, announcing on Wednesday that adolescents should receive only one dose of the Moderna vaccine.

Amy Schoenfeld Walker contributed reports.