HomeHealthFDA advisers are recommending that the agency license Moderna and Pfizer's long-awaited...

FDA advisers are recommending that the agency license Moderna and Pfizer’s long-awaited Covid vaccines for young children.


Credit…Alisha Jucevic for The New York Times

Outside advisers to the Food and Drug Administration voted unanimously Wednesday to recommend that the agency license the Moderna and Pfizer-BioNTech coronavirus vaccines for very young children, a move that could clear the way for regulators to license both vaccines. pediatric on an emergency basis later. this week.

Pfizer’s three-dose vaccine would cover children ages 6 months to 4 years, while Moderna’s two-dose vaccine would cover children ages 6 months to 5 years. States have already ordered millions of doses. Depending on what regulators do, White House officials have said dose management could begin in earnest as early as Tuesday.

The FDA has said that the companies’ clinical trial data show that each vaccine met criteria for safety and efficacy in the age group.

More than two years into the pandemic, no vaccine has been licensed for children under 5 in the United States, an unmet need that has dismayed many parents. The FDA is expected to act on the recommendations promptly, followed by the Centers for Disease Control and Prevention later this week.

The advisory panel voted 21-0 to recommend authorization of the Moderna and Pfizer vaccines. “I know the death rate from Covid and young children may not be extremely high,” said Dr. Jay Portnoy, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo. But he said, “It’s absolutely terrifying for parents to have your sick child” or hospitalized.

“There are so many parents who are absolutely desperate to get this vaccine,” he added, “and I think we owe it to them to give them the choice.”

Both of the vaccines that the committee considered on Wednesday appear significantly less effective against symptomatic infection than the adult vaccines when they were introduced. The FDA claims that Omicron is much more adept at evading vaccine defenses against infection than the original version of the virus.

Given the decline in protection seen among adult recipients and the rapid evolution of the virus, regulators have said that children who would receive the Pfizer and Moderna vaccines would likely need a booster. That would mean Pfizer’s vaccine, developed with the German firm BioNTech, could end up in four doses, while Moderna’s could be three.

Both the Pfizer-BioNTech and Moderna vaccines elicited levels of virus-neutralizing, or blocking, antibodies among children comparable to those among adolescents and young adults ages 16 to 25. Pfizer’s vaccine has been licensed for children ages 5 to 15 since last year, and regulators said it helped prevent hospitalizations and deaths.

After two doses, Pfizer’s vaccine was only 28 percent effective in preventing symptomatic infections in children 6 months to 4 years of age. Pfizer suggested the vaccine was 80 percent effective after a third dose, but the finding was based on just 10 cases from a subset of the 1,678 trial participants. The trial protocol specified that assessments of vaccine efficacy be based on at least twice as many cases; the small number of cases on which the efficacy finding was based was cause for consternation among committee members and regulators on Wednesday.

Dr. Doran Fink, a top federal vaccine regulator, called Pfizer’s efficacy data preliminary. “We consider it to be imprecise and potentially unstable,” he said. “Exactly how effective the vaccine is after the third dose needs more data.”

Moderna found its vaccine to be 51% effective in preventing symptomatic infections in children 6 months to 2 years old, and 37% effective in children 2 to 5 years old. Those results appear consistent with those reported in studies of adults during the Omicron era, the FDA said. Still, immunization continues to offer strong protection against serious illnesses that lead to hospitalization and death.

Regulators and company officials spent part of the day discussing side effects caused by vaccines. The vast majority were mild and tolerated by children in clinical trials: irritability and crying, drowsiness, fatigue, and loss of appetite. A smaller number of trial participants suffered from fever, but that was consistent with the effects of other pediatric vaccines.

In younger age groups, fevers can be more debilitating and require more urgent medical attention, a dynamic that puts significant pressure on manufacturers to calibrate dosage correctly. Pfizer chose a dose just one-tenth the adult dose, given as three injections; the first two are given three weeks apart, with the third arriving at least eight weeks after the second. Moderna used a quarter strength of its adult dose, given as two injections, four weeks apart.

Some tough questions remain. It is important to note that none of the vaccines have been tested against the subvariants circulating in the United States. Clinical trials were largely conducted when the Omicron variant was prevalent. Two subvariants, BA.4 and BA.5, could become dominant within a month.

The need to protect these children of Covid is great, Dr. Peter Marks, the FDA’s top vaccine regulator, said at the meeting. He added that hundreds of children had died of Covid, a rate that he said “compares terribly” with pediatric deaths during a flu surge in 2009 and 2010.

Correction:

June 15, 2022

Due to an editing error, an earlier version of this article incorrectly stated when the Pfizer-BioNTech vaccine was licensed for different age groups in the United States. The vaccine was licensed for ages 16 and older in late 2020, not in 2021, when vaccines for children ages 5 to 15 were licensed.



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