WASHINGTON — In a striking reversal, federal regulators said on Friday that they would wait for data on how well three doses of Pfizer-BioNTech’s coronavirus vaccine work in children younger than 5 before deciding whether to authorize the vaccine for that age group.The decision by the Food and Drug Administration most likely rules out shots for roughly 18 million of the nation’s youngest children until at least April. The Biden administration had been hoping to expand vaccination to those 6 months through 4 years of age as early as next week. They are the only Americans not yet eligible for shots.Pfizer-BioNTech asked for the delay after the companies discovered that the Omicron wave had led to a far higher rate of infection than they had previously recorded among young volunteers in their clinical trial. The new data underscored that the Omicron variant was better than the earlier Delta variant at evading the vaccine’s protection, and it showed that two doses, which had already fallen short by another measure, were not effective enough.As a result, the companies and the F.D.A. agreed to wait for the results from a third dose, which are expected in early April.The turnabout came as the Centers for Disease Control and Prevention released data on Friday showing that booster shots of the Pfizer and Moderna vaccines lose some of their effectiveness against emergency room visits and hospitalizations by the four-month point. The agency said the data was some of earliest evidence on the durability of boosters. While it showed three doses offered better protection than two, it raised sobering questions about how long that protection lasts against severe disease.Together, the two developments dampened some earlier optimism about the power of vaccines. They also presented at least a temporary setback for the Biden administration’s vaccination campaign.Researchers hope that by April, Pfizer and BioNTech will be able to demonstrate that three doses protect children, with data showing both stronger immune responses and more success in warding off symptomatic infections.The companies said in a news release that they would wait for the data on a three-dose vaccine given the study’s rapid pace and because they “continue to believe it may provide a higher level of protection in this age group.”The F.D.A. began pressing Pfizer-BioNTech to seek authorization for a two-shot regimen weeks ago, despite disappointing results from the trial that were announced in December. Children ages 2 through 4 produced only 60 percent of the antibody levels that older teens and young adults did. The older age group was used as a benchmark because the vaccine had proven effective for them.Children 6 months to 2 years did produce the sought-after level of antibodies. The dosage was one-tenth of that given to those 12 and older, and there were no serious safety concerns, officials have said.This month, Pfizer-BioNTech submitted a request for emergency authorization, and the F.D.A. scheduled a meeting of its outside advisory committee for next Tuesday, saying it hoped to get a head start on vaccinating young children with two shots, likely adding a third later.Then, late on Thursday, Pfizer alerted the F.D.A. that it had more recent data, from mid-January on, showing a more discouraging picture as the Omicron variant bore down. The new data revealed that two doses were not sufficiently effective in preventing symptomatic infection. The illness was generally mild and no children were hospitalized, according to people familiar with the study.In a call with reporters on Friday, Dr. Peter Marks, the F.D.A.’s top vaccine regulator and an advocate of the two-dose strategy, said the latest data had forced a new reckoning. “Yes, some of this was late breaking,” he said, “but that’s what our job is — to adjust to it.”While many pediatric experts had been sympathetic to the F.D.A.’s initial push to consider two doses, some said on Friday that the regulators were right to hold off.“I honestly let out a woo-hoo of elation that reason and science had prevailed, and that they actually really did do the right thing,” said Dr. James Conway, a pediatric infectious disease expert at the University of Wisconsin-Madison and a fellow of the American Academy of Pediatrics.The Coronavirus Pandemic: Latest Updates
Updated Feb. 11, 2022, 7:55 p.m. ETNew studies underscore the dangers of pregnancy complications for unvaccinated women with Covid.Scientists prepare for the next phase of learning to live with Covid.Mayor Adams says the rush of last-minute vaccinations by New York City workers is an encouraging sign.Dr. Conway said he had been concerned that prematurely authorizing a partial vaccine regimen for young children without compelling data would haveBy: Sharon LaFraniere and Noah Weiland
Title: In Reversal, F.D.A. Delays Push for Shots for Children Under 5
Sourced From: www.nytimes.com/2022/02/11/us/politics/fda-children-pfizer-vaccine.html
Published Date: Sat, 12 Feb 2022 01:06:35 +0000
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