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

WASHINGTON — Pfizer and BioNTech said connected Thursday greeting that they had asked national regulators to authorize exigency usage of their coronavirus vaccine for children ages 5 to 11, a determination that could assistance support much than 28 cardinal radical successful the United States.

The companies person said they were submitting information supporting the alteration to the Food and Drug Administration. The bureau has promised to determination rapidly connected the petition and has tentatively scheduled a gathering connected Oct. 26 to see it. A ruling is expected betwixt Halloween and Thanksgiving.

Parents crossed the United States are anxiously awaiting the regulators’ decision, which could impact household beingness and the cognition of schools. Clearance depends not lone connected the spot of the objective proceedings data, but connected whether they tin beryllium to regulators that they are capable to decently manufacture a caller pediatric formulation.

Dr. Janet Woodcock, the acting F.D.A. commissioner, said past week that children mightiness necessitate “a antithetic dosage oregon formulation from that utilized successful an older pediatric colonisation oregon adults.”

Pfizer has projected giving children one-third of the big dosage. That mightiness necessitate adding much diluent to each injection oregon utilizing a antithetic vial oregon syringe. The institution was expected to picture the method it intended to usage successful its submission to the Food and Drug Administration.

Regulators volition person to analyse the purity and stableness of mass-manufactured doses of the vaccine and find that it matches the prime and potency of doses fixed to children successful objective trials. A pediatric dose volition besides astir apt necessitate caller labeling, with peculiar codes that would let the Centers for Disease Control and Prevention to way circumstantial tons successful lawsuit of reports of superior broadside effects.

Children seldom go severely sick from Covid-19, but the Delta variant drove nearly 30,000 of them to hospitals successful August. According to the American Academy of Pediatrics, nearly 5.9 cardinal Americans younger than 18 person been infected with the coronavirus. Of the astir 500 Americans nether 18 who person died, astir 125 were children ages 5 to 11.

“It truly bothers maine erstwhile radical accidental kids don’t dice of Covid,” said Dr. Grace Lee, an subordinate main aesculapian serviceman astatine Stanford Children’s Health who besides leads a cardinal advisory committee to the C.D.C. “They dice of Covid. It’s heartbreaking.”

About 1 successful each six Americans infected since the opening of the pandemic was nether 18 years old. But with the surge of the Delta variant, children accounted for arsenic galore arsenic 1 successful 4 infections past month, according to the American Academy of Pediatrics. The Food and Drug Administration authorized exigency usage of Pfizer’s vaccine for 12- to 15-year-olds successful May.

The infection complaint successful the United States is presently falling, prompting anticipation that the Delta variant is ebbing. But nationalist wellness experts interest that the onset of colder upwind could effect successful accrued transmission.

Although national regulators are nether tremendous unit to rapidly reappraisal Pfizer’s application, they besides look different pressing decisions. Next week, they mightiness regularisation connected whether radical who received the Moderna and Johnson & Johnson coronavirus vaccines should person booster shots, some perchance contentious decisions.

Public wellness experts person said that the agency’s reappraisal of a Pfizer pediatric dose would beryllium intimately scrutinized. According to a caller survey conducted by the Kaiser Family Foundation, astir a 3rd of parents of children betwixt ages 5 and 11 said they would hold and spot earlier allowing their children to person specified a shot.

Dr. Walt A. Orenstein, an epidemiologist astatine Emory University and a erstwhile manager of the U.S. immunization program, said that fixed the competing pressures connected the Food and Drug Administration to marque vaccine decisions rapidly but carefully, nationalist treatment was essential.

He said galore parents were wavering betwixt fearfulness of Covid-19 and fearfulness of broadside effects of a pediatric vaccine. If they were little disquieted astir the consequences of coronavirus infection, helium said, information would beryllium their apical priority. If they were much worried, the vaccine’s effectiveness would substance more. As with different vaccines, Dr. Orenstein said, pediatricians would play a captious relation successful easing parental anxiety.

Pfizer’s objective proceedings for children was not intended to gully meaningful conclusions astir the vaccine’s quality to forestall illness oregon hospitalizations. Instead, researchers looked astatine antibody levels, comparing them with levels successful adults that had conferred precocious protection. Regulators are expected to comparison those immune responses to vaccine efficacy information successful the big population.

The proceedings included 2,268 children, two-thirds of whom had received 2 doses of the vaccine 3 weeks apart. The remaining volunteers were injected with 2 doses of saltwater placebo. Regulators implicit the summertime asked for the proceedings size to beryllium expanded to 3,000 children.

At a virtual sheet connected Covid-19 past week, Norman Baylor, the erstwhile manager of the Food and Drug Administration’s vaccines office, said that the fig of participants successful Pfizerpediatric survey was noticeably small. The big proceedings progressive astir 44,000 people.

“It does beg the question of the size, fixed what we person for the adults: Would 1 expect much for the pediatric population?” helium said. “They whitethorn beryllium thinking, ‘Well, we cognize the vaccine is safe, due to the fact that look astatine however galore radical we had successful the adults.’ But arsenic we know, things whitethorn displacement successful that pediatric population.”

The Pfizer-BioNTech and Moderna vaccines person been tied to accrued risks of myocarditis, oregon inflammation of the bosom muscle; and pericarditis, inflammation of the lining astir the heart, peculiarly successful younger men. In August, the Food and Drug Administration published results from an investigation of Pfizer-BioNTech’s vaccine that utilized a U.S. wellness attraction claims database and recovered that the hazard of the conditions successful 16- and 17-year-old vaccinated boys could beryllium arsenic precocious arsenic 1 successful 5,000.

The cases successful the database were unconfirmed, but they were considered a tenable estimation of imaginable risk, the bureau wrote.

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

Officials successful a fig of countries person recommended a azygous dose of the Pfizer-BioNTech vaccine for children ages 12 and older, which would supply partial extortion from the virus, but without the imaginable effects occasionally observed aft 2 doses. Sweden and Denmark joined those countries, announcing connected Wednesday that adolescents should get lone 1 dose of the Moderna vaccine.

Amy Schoenfeld Walker contributed reporting.