Beltway Confidential

The FDA’s waiting game is costing children’s lives

By Sally Pipes

Published September 30, 2021 11:00am ET

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The FDA’s waiting game is costing children’s lives — President Trump signed into law the FDA Reauthorization Act of 2017 on Friday. It reauthorizes a program in which drug and device makers pay the FDA a fee for every new product application, and the agency uses that money to hire more people and speed up approvals. (AP Photo/Andrew Harnik, File) | Andrew Harnik

This week, Pfizer-BioNTech submitted data to the Food and Drug Administration demonstrating the safety and effectiveness of its COVID-19 vaccine in children ages 5 to 11. The duo is expected to apply for emergency-use authorization in the coming weeks.

Federal regulators have promised they’ll “urgently” review the data. The FDA’s Dr. Peter Marks told USA Today the data would be “looked at if not within hours, certainly within the day.”

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COVID-19 FDA