The Food and Drug Administration has approved Pfizer’s Covid-19 vaccine for use in children ages 5-11, setting the stage for the age group to begin receiving their first doses as early as next week. The Centers for Disease Control is expected to meet Tuesday and Wednesday to discuss offering a recommendation. If they do, kids could start receiving the vaccine on Thursday.
The FDA authorization comes three days after the agency’s vaccine advisers voted 17-0 (with one abstention) to endorse the vaccine for children, noting that the benefits outweigh the risks. The panel recommended giving children two shots of one-third of the dose given to people 12 and older, three weeks apart.
FDA regulators reached the same conclusion in an analysis published last week. “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,” the report read. Myocarditis is a rare heart inflammation condition that has been linked with the Pfizer and Moderna vaccines.
The analysis found that the Pfizer vaccine had a 90.7-percent efficacy rate in preventing symptomatic Covid-19 in children aged 5-11.
Pfizer and BioNTech asked earlier this month for the FDA to approve the vaccine for children. “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid-19,” Pfizer wrote on Twitter in announcing that they had submitted the approval request.
In August, nearly 30,000 children were hospitalized with Covid-19. The surge in cases among children was attributed to the more-contagious Delta variant of the disease. Cases among people 18 and under peaked in early September, with close to 250,000 having been reported in the first month’s first week, according to The New York Times. The infection rate has since fallen, and by mid-October the number was at 130,000, marking a steep decline but still enough to represent a quarter of the nation’s cases, according to the American Academy of Pediatrics.
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