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

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

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.”

Speed is of the utmost importance. The FDA has already slowed the vaccine approval process for children by ordering bigger, longer trials. Insisting on more data may sound reasonable. But it’s not a costless exercise.

The week of Sept. 23 marked the fifth consecutive week in which the United States recorded over 200,000 pediatric COVID-19 cases. In the first week of September, nearly 400 children under 17 were admitted to the hospital with COVID-19 — the highest number recorded since the pandemic began. In Florida, total childhood fatalities from the virus more than doubled in a month as the school year began in August.

Although COVID-19 fatalities among children are rare, recent research shows COVID-19 symptoms can linger for months. More than 4,500 cases of an inflammatory syndrome associated with COVID-19 have been reported in children as of Sept. 1. A month or more of waiting for the FDA’s thumbs-up could mean hundreds of thousands more children will contract COVID-19. It’s essential that parents who want to vaccinate their children have that option sooner rather than later.

The FDA says it will “follow the science” when reviewing COVID-19 vaccines for children. Doing so also requires acknowledging the escalating crisis of pediatric COVID-19 cases — and acting quickly to put an end to it.

Sally C. Pipes is president, CEO, and Thomas W. Smith fellow in Health Care Policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All  (Encounter 2020). Follow her on Twitter @sallypipes.