The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps next week, a long-awaited development that would affect 28 million children.
Pfizer reported long-awaited data on Friday showing that its coronavirus vaccine had a 90.7 percent efficacy rate in preventing symptomatic Covid-19 in a clinical trial of 5- to 11-year-olds, a finding that may lead to the first authorization of a vaccine to protect young children from the virus. The company and its partner BioNTech submitted the information to the Food and Drug Administration, which was expected to release its own analysis of the data on Friday night. The findings could add momentum for F.D.A. authorization of the pediatric dose on an emergency basis, perhaps as early as next week, opening a new phase of the nation’s vaccination campaign. The agency’s independent committee of vaccine experts is set to vote Tuesday on whether to recommend authorization. If the F.D.A. rules in favor 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. The Biden administration has been eagerly promoting the prospect, and many parents are anxiously 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 remain 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 two percent 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.
