US FDA says Pfizer vaccine’s benefits outweigh key risks in children 5 to 11

Federal regulators evaluated for the first time Friday the safety and efficacy of a coronavirus vaccine for children ages 5-11, saying that the benefits of staving off COVID-19 with the Pfizer-BioNTech vaccine generally outweighed the risks of the most worrisome possible side effects in that age group.

The analysis came on the same day that the Food and Drug Administration posted data from Pfizer showing that the vaccine had a 90.7% efficacy rate in preventing symptomatic COVID-19 in a clinical trial of 5- to 11-year-olds, reports The New York Times.

The findings could add momentum for FDA authorization of the pediatric dose on an emergency basis, perhaps as early as next week, opening up a long-awaited new phase of the nation’s vaccination campaign. The agency’s independent vaccine expert committee is set to vote Tuesday on whether to recommend authorization.

In a briefing document posted on the FDA website, the agency said it had balanced the dangers of hospitalization, death or other serious consequences from COVID-19 against the risk of myocarditis. A rare condition involving inflammation of the heart muscle, myocarditis has been linked to the Pfizer-BioNTech and Moderna vaccines, especially among young men.

“The overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases,” regulators wrote.

As is customary before a vote of the FDA’s advisory committee, the regulators took no stance on whether the new use of a vaccine should be authorized.

If the FDA rules in favour of authorization and the Centers for Disease Control and Prevention and its own panel of vaccine experts agree, the 28 million children in that age group could become eligible for shots in the first week of November.

“There’s a lot of data to be encouraged by,” said Dr Kathryn M. Edwards, a professor of paediatrics in the division of infectious diseases at Vanderbilt University School of Medicine. She said the results exceeded the protection offered by the best flu vaccine and could eventually lead to the easing of restrictions intended to prevent elementary school children from contracting the virus.

The Biden administration has been promoting the prospect of a pediatric shot, and many parents are eagerly awaiting the development. COVID-19 cases among those younger than 18 peaked in the first week of September, when nearly a quarter of a million cases were reported.

But they have remained high, with more than 130,000 cases reported in the second week of October, the American Academy of Pediatrics said, accounting for a quarter of all cases nationwide. Fewer than 2% of those cases resulted in hospitalization, but that figure was based on data from only half the states, the organization said.

Pfizer and BioNTech announced a month ago that their vaccine worked well for young children, but no comprehensive clinical data was released publicly until Friday. Children in the trial received two doses of 10 micrograms — one-third of the adult dose — three weeks apart. Researchers said that the dosage was safe, and that trial participants had seen only mild side effects.

Of 2,268 children in the trial, twice as many were given the vaccine as received a placebo. Sixteen children who received the placebo got COVID-19, compared with three who received the vaccine. All of the COVID cases occurred in July or later, as the highly transmissible delta variant was spreading in the United States and globally, according to the company. The FDA said it could not determine whether the cases were caused by the delta variant.

Pfizer said it had follow-up safety data for an additional 2,250 children, but only for a median of 2 1/2 weeks after they received a second dose.