FDA Says Benefits Of Pfizer's COVID-19 Vaccine Outweigh Risks In Children 5 To 11
Headline Roundup October 24th, 2021
Food and Drug Administration regulators shared a study on Friday that said the benefits of the Pfizer-BioNTech vaccine for children ages 5 to 11 “would clearly outweigh” any serious side effects. On the same day, the FDA posted data from Pfizer and BioNTech that showed their vaccine had a 90.7% efficacy rate in preventing symptomatic COVID-19 infections in a clinical trial of 5-to 11-year-olds. Both sets of data were released ahead of the agency's advisory board meeting on Tuesday, where members will vote on whether to approve the pediatric shot. If approved, the CDC will move forward with its own review — meaning the 28 million children in the 5-11 age group could become eligible for the Pfizer vaccine as early as the first week of November.
Coverage was mostly balanced across the spectrum, with most outlets linking back to the FDA's studies. Left-rated outlets were more likely to emphasize how "reluctance among parents of teenagers" dropped in the months since vaccines became available to 12-to 15-year olds, indicating that the trend could continue with parents that have children in the 5-11 age group. Right-rated outlets were more likely to highlight how the Biden administration "has already purchased enough kid-size doses" before getting the green light from the FDA and CDC.
Food and Drug Administration regulators said Friday that the benefits of the Pfizer-BioNTech vaccine for children far outweigh the risks for children ages 5 to 11.
Why it matters: The announcement could add momentum to the FDA's authorization of doses for children on an emergency basis, which could happen as early as next week, according to the New York Times.
Driving the news: The remarks came on the same day that the FDA released data showing the Pfizer vaccine had a 90.7% efficacy rate in preventing symptomatic COVID-19 in a trial of 5- to 11-year-olds.
Food and Drug Administration researchers found the Pfizer-BioNTech vaccine to be highly effective at protecting kids from COVID-19 – as federal regulators inch closer to greenlighting child-sized doses for 5-11 year-olds.
FDA researchers concluded in a study shared Friday that the Pfizer vaccine’s benefits in preventing hospitalizations and deaths “would clearly outweigh” any serious side effects in children.
The study was posted ahead of next week’s public meeting with a panel of outside expert advisers who will meet on Tuesday to advise the agency before it decides whether or not...
Federal regulators evaluated for the first time on Friday the safety and efficacy of a coronavirus vaccine for children 5 to 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 percent efficacy rate in preventing symptomatic Covid-19 in a clinical trial of 5- to 11-year-olds.