Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 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 ages 5 to 11, a move that could help more than 28 million people in the United States. to protect.

The companies have said they have submitted data to the Food and Drug Administration in support of the change. The agency has promised to respond to the request quickly and has tentatively scheduled a meeting on October 26 to consider it. A ruling is expected between Halloween and Thanksgiving.

Parents in the United States eagerly await the decision of the regulators, which could affect family life and the operation of schools. The approval depends not only on the strength of the clinical trial data, but also on whether they can prove to regulators that they are able to properly manufacture a new pediatric formulation.

dr. Janet Woodcock, the acting FDA commissioner, said last week that children may “need a different dosage or formulation than that used in an older pediatric population or adults.”

Pfizer has suggested giving children a third of the adult dosage. This may require adding more diluent to each injection or using a different vial or syringe. The company was expected to describe the method it planned to use in its filing with the Food and Drug Administration.

Regulators will need to examine the purity and stability of mass-produced doses of the vaccine and determine whether it matches the quality and potency of doses given to children in clinical trials. A pediatric dose will most likely also require new labeling, with special codes that allow the Centers for Disease Control and Prevention to track specific batches in the event of reports of serious side effects.

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

“It really bothers me when people say that children don’t die from Covid,” said Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Health, who also heads a major CDC advisory committee. “They are dying of Covid. It’s heartbreaking.”

About one in six Americans infected since the start of the pandemic were under the age of 18. But with the rise of the Delta variant, children were responsible for as many as one in four infections last month, according to the American Academy of Pediatrics. The Food and Drug Administration approved the emergency use of Pfizer’s vaccine for 12- to 15-year-olds in May.

The infection rate in the United States is currently declining, raising hopes that the Delta variant will fade. But public health experts worry that the onset of colder weather could lead to increased transmission.

Updated

Oct 7 2021, 8:52 a.m. ET

While federal regulators are under tremendous pressure to review Pfizer’s filing quickly, they also face other urgent decisions. Next week, they can decide whether people who have received the Moderna and Johnson & Johnson coronavirus vaccines should receive booster shots, both potentially controversial decisions.

Public health experts have said the agency’s assessment of a pediatric dose of Pfizer would be scrutinized. According to a recent survey conducted by the Kaiser Family Foundation, about a third of parents of children between the ages of 5 and 11 said they would wait and see before giving their children such an injection.

dr. Walt A. Orenstein, an epidemiologist at Emory University and former director of the U.S. immunization program, said public discussion was essential given the competing pressure on the Food and Drug Administration to make quick but careful vaccine decisions.

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

The State of Vaccine Mandates in the US

Vaccine Rules. On August 23, the FDA gave full approval to Pfizer-BioNTech’s coronavirus vaccine for people ages 16 and older, paving the way for mandates in both the public and private sectors. Such mandates are permitted by law and have been confirmed in court proceedings.College and universities. More than 400 colleges and universities are demanding that students be vaccinated against Covid-19. Nearly all of them are in states that voted for President Biden.schools. California became the first state to issue a vaccine mandate to all educators, announcing plans to add the Covid-19 vaccine as a pre-school requirement, which could begin as early as next fall. Los Angeles already has a vaccine mandate for public school students ages 12 and older that begins Nov. 21. New York City’s mandate for teachers and staff, which went into effect Oct. 4 after delays due to legal challenges, appears to have taken thousands of last-minute recordings.Hospitals and Medical Centers. Many hospitals and major health systems require workers to be vaccinated. Health worker mandates in California and New York State appear to have forced thousands of people to receive shots.Indoor Activities. New York City requires employees and customers to show evidence of at least one dose of the Covid-19 for indoor dining, gyms, entertainment and performances. Beginning Nov. 4, Los Angeles will require most people to provide proof of full vaccination to gain entry to a range of indoor businesses, including restaurants, gyms, museums, movie theaters and salons, under one of the nation’s strictest vaccine regulations.At the federal level. on September 9 President Biden announced a vaccine mandate for the vast majority of federal employees. This mandate applies to employees of the executive branch, including the White House and all federal agencies and members of the armed forces.in the private sector. Mr Biden has mandated that all companies with more than 100 employees require vaccination or weekly testing, which will help drive new company vaccination policies. Some companies, such as United Airlines and Tyson Foods, already had mandates before Mr. Biden’s announcement.

Pfizer’s pediatric clinical trial was not intended to draw meaningful conclusions about the vaccine’s ability to prevent illness or hospitalization. Instead, researchers looked at antibody levels and compared them to levels in adults who had conferred high levels of protection. Regulators are expected to compare those immune responses with data on vaccine efficacy in the adult population.

The trial involved 2,268 children, two-thirds of whom had received two doses of the vaccine three weeks apart. The remaining volunteers received two doses of saltwater placebo. Regulators asked in the summer to expand the trial size 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 vaccine agency, said the number of participants in the Pfizerpediatric study was remarkably small. The adult trial involved about 44,000 people.

“It begs the question of size, given what we have for the adults: would you expect more for the pediatric population?” he said. “They might be thinking, ‘Well, we know the vaccine is safe because look how many people we had in the adults.’ But as we know, things can change in that pediatric population.”

The Pfizer-BioNTech and Moderna vaccines are linked to an increased risk of myocarditis, or inflammation of the heart muscle; and pericarditis, inflammation of the mucous membrane around the heart, especially in younger men. In August, the Food and Drug Administration released results of an analysis of Pfizer-BioNTech’s vaccine, which used a database of health claims in the US, 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 had not been confirmed, but they were considered a reasonable estimate of the potential risk, the agency wrote.

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

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

Amy Schoenfeld Walker contributed to the report.

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