Expert: FDA’s call for more children in COVID vaccine trial could signal delays

Published: Jul. 28, 2021 at 3:22 PM EDT|Updated: Jul. 28, 2021 at 6:52 PM EDT
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BURLINGTON, Vt. (WCAX) - More children need to be included in pediatric trials for Pfizer and Moderna’s COVID-19 vaccines.

That’s the word from federal regulators to the companies recently, telling them to recruit at least 3,000 participants ages 5 to 11. The goal is to better detect any potential safety issues -- like heart inflammation -- after receiving a vaccine. A wider study size makes finding rare side effects more likely. It’s still unclear if this requirement will impact when kids under 12 could get the vaccine.

The University of Vermont Larner College of Medicine Vaccine Testing Center is not involved with either Pfizer or Moderna’s trials, but its director, Dr. Beth Kirkpatrick, the answer to that timeline question comes down to what the FDA needs that extra data for. “If we need more kids now to get to understand rate -- the efficacy rate -- and the safety of the vaccine, it might actually take longer,” she said.

Pfizer says it plans to release data from its pediatric study in September. Moderna told the Washington Post that it predicts authorization in “winter 2021 or early 2022.” The Post also reported that a federal official predicted authorization for kids 5 to 11 by late October or early November.

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