The regulatory work now moves to the CDC, whose vaccine advisers are slated to meet November 2 to review the data. Matthew Oster, a pediatric cardiologist and member of CDC's COVID-19 response team, said during a presentation to FDA advisers that the risk to Black children was "a double-hit." Black and Hispanic kids have made up a disproportionate share of COVID-related hospitalizations among kids 5 to 11 and cases of multi-system inflammatory syndrome - a condition tied to COVID-19 infection that can result in inflammation of certain organs - are also more common among Black children.ĭr. "Data show that the vaccine works and it's pretty safe, at least by immuno-bridging and even by some early clinical data, and yet we're worried about a side effect that we can't measure yet but it's probably real."ĭata from the CDC shows that myocarditis is most common among men under 30 after the second dose of Pfizer or Moderna mRNA vaccines, but severe outcomes are rare and no deaths have been reported.īut the FDA's advisers also said they felt compelled to act on behalf of children at higher risk of severe illness from COVID-19, and to help address racial disparities in COVID's impact on children. "This is a much tougher one I think than we had expected coming into it," said Dr. No cases were reported during the clinical trial in kids, but some have been seen in older age groups. While most members of the Vaccines and Related Biological Products Advisory Committee ultimately coalesced around supporting the shot, some voiced concerns about the need for more data on potential side effects, specifically the risk of myocarditis and pericarditis, inflammation of different parts of the heart. The emergency use authorization granted by the FDA comes after a near-unanimous vote by the agency's advisers on Tuesday endorsing the benefits of the vaccine. "Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards," she said. Janet Woodcock said vaccinating younger children "will bring us closer to returning to a sense of normalcy." In a statement, acting FDA Commissioner Dr. The authorized dose is a third of the size of the dose for other age groups, and was found to be nearly 91% effective against symptomatic disease in a clinical trial.Īdvisers for the Centers for Disease Control and Prevention will meet Tuesday, November 2, to review the data and vote on their own recommendation, and if the CDC director agrees, shots could be available as soon as the following day.
The Food and Drug Administration authorized a smaller dose of Pfizer's COVID-19 vaccine for children ages 5 to 11, a critical step for the more than 28 million children that may soon be eligible.
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