FDA advisers endorse Covid-19 vaccine for kids 5-11

·4 min read

The Food and Drug Administration's independent vaccine advisers voted Tuesday to recommend authorizing the Pfizer-BioNTech Covid-19 shot for children ages 5-11, after deliberating whether everyone in that age group should be eligible for immunization.

Panel members voted 17-0 to recommend the shot, with one abstention.

The question before the committee was whether the vaccine's benefits outweigh its risks "based on the totality of scientific evidence available," when the shot is given as two doses three weeks apart.

Data presented by the Centers for Disease Control and Prevention showed that children ages 5 to 11 are "at least as likely" as adults to contract Covid-19, and surveillance testing suggests pediatric cases are widely underreported. Hospitalization rates also are three times higher for children of color than for white kids, highlighting racial disparities also seen among adult patients.

Kathrin U. Jansen, Pfizer's senior vice president and head of vaccine research and development, applauded the vote.

"About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications," she said in a statement. "In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner."

An FDA staff analysis released late Friday suggested the product's benefits outweigh the risks of adverse side effects to kids. However, the document also noted that balance could change if Covid case rates again fell to those seen in June, depending on the extent to which instances of myocarditis — an inflammatory heart condition linked to messenger RNA vaccines — occur in that age group.

The modeling FDA relied upon for the analysis used a conservative estimate of myocarditis cases in 5- to 11-year-olds, agency representatives said, an age range that doesn't typically experience many instances of the condition.

Still, some panel members expressed reservations about recommending the shot's broad use for children that age, suggesting that CDC's outside experts may consider whittling down the eligible population to kids at highest risk for complications.

"This vaccine should be available to those parents who are very eager [for their child] to get it, because their child has a comorbidity or because they’re concerned themselves," said Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, before voting to recommend the shot.

"I'm just worried that if we say yes that the states are going to mandate administration of this vaccine to children in order to go to school, and I do not agree with that," he added. "I think that would be an error at this time until we get more information about the safety.”

Matthew Oster of the CDC's Center on Birth Defects and Developmental Disabilities said not all myocarditis cases are the same, noting that vaccine-induced cases appear to resolve more quickly than those caused by viruses or multisystem Inflammatory syndrome in children, known as MIS-C. The agency is currently surveying myocarditis patients whose cases were reported to vaccine side effect registries to collect more data on the long-term effects of the condition.

No myocarditis cases occurred during pediatric clinical trials, Pfizer said. But the company also noted its trial size, while doubled at FDA's request, wasn't large enough to detect such a rare event. The company's study enrolled more than 4,600 children, of whom roughly 3,100 received the vaccine; the remainder received a placebo.

Doctors routinely vaccinate children against diseases that cause far fewer intensive care unit admissions and deaths, and Covid — namely, severe cases of it — has proven to be a vaccine-preventable disease, said Amanda Cohn, a CDC pediatrician who sits on the FDA panel.

“To me the benefit is clear," she said. "We don’t want children to be dying of Covid, even if it is far fewer children than adults.”

Cohn noted that the CDC's advisory committee could opt to make “more focused or nuanced recommendations" on who within the 5- to -11-year-old age group should get the vaccine, but couldn't go broader than the language of FDA's eventual emergency use authorization

The vaccine would be administered in 10-microgram doses to children under 12, which amounts to one-third the size of each dose provided to teens and adults. Pfizer says its data shows the vaccine is nearly 91 percent effective in that age group.

Panel members raised two scenarios to Pfizer: Whether older children in the age group should wait until they're 12 to get a higher dose of the vaccine, and, conversely, whether the lower dose would be just as effective in a 12-year-old as it is for younger children.

Bill Gruber, Pfizer's senior vice president for vaccine clinical research and development, said the vaccine has produced a comparable antibody response across all age groups, despite the smaller dose for younger kids.

While the company doesn't yet have data for the lower dose in a slightly older population, Gruber said, Pfizer is "thinking about that as a potential option, particularly as we move out of the pandemic period.”

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