Blame the FDA for closing schools
This crisis was avoidable. By showing no sense of urgency to approve COVID-19 shots for children under 12, the Food and Drug Administration has left children vulnerable — not just to the virus but to the emotional and social harm caused by missing in-person interactions with their teachers and peers.
The shots could have been approved by now if not for the FDA’s decision last month to require six months of clinical trial data on the effect of Pfizer-BioNTech’s and Moderna’s COVID-19 shots in children between the ages of 5 and 11. Regulators also ordered the two vaccine makers to double the number of children in their trials.
They only asked for two months of data before approving the shots for adults.
The FDA’s decision prompted rare public criticism from the American Academy of Pediatrics, which urged the agency to use already available data to speed up approval for children aged 5-11 rather than erecting new barriers that would slow the process down. The pediatricians’ group is right — further delaying approval of the vaccines for young children is out of step with the reality of increasing cases and hospitalizations within this age group.
According to the Centers for Disease Control and Prevention, an average of 351 children were admitted to the hospital every day between Aug. 25-31. That’s more than quadruple the COVID-19 hospitalization rate for children last August. And it’s 60% higher than the previous peak COVID-19 hospitalization rate for children this past January.
And it’s only September. When the weather cools and people spend more time indoors, the spread of COVID-19 could be catastrophic. One recent analysis from North Carolina State University researchers concluded that in an elementary school with neither mask usage nor testing, three-quarters of students could be infected by Thanksgiving.
The FDA’s response to this dire situation should concern us all. Schools will continue to close, and hospital beds will continue to fill up until the agency approves the COVID-19 vaccines for children — and gives parents the option to vaccinate their children.
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.