Twelve former US Food and Drug Administration (FDA) commissioners yesterday published a commentary calling out Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, for proposing sweeping changes to vaccine safety regulation based on what he claims, without presenting evidence, are 10 deaths in children caused by COVID-19 vaccines.

In addition, Senator Bill Cassidy, MD (R-La.), on the social media platform X called for a full Senate briefing on the deaths.

Proposed changes are ‘major shift’ for FDA

“We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” wrote the former FDA directors in the New England Journal of Medicine.

“The proposed new directives are not small adjustments or coherent policy updates,” the group add. “They represent a major shift in the FDA’s understanding of its job.”

FDA has not published any data around the alleged deaths or explained the process they took to verify it. I’ve asked FDA for a full briefing on this.

They ex-commissioners write, “The stated motivation for these sweeping changes is the deaths of 10 children, which the FDA leadership asserts were caused by Covid-19 vaccines. … The memo [from Prasad] offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation.

“The reanalysis relied on adverse event reports filed in the Vaccine Adverse Event Reporting System (VAERS), a passive postapproval surveillance system that collects unverified reports, from any source, of events occurring after vaccination. VAERS reports, by themselves, cannot be used to determine whether a vaccine caused a particular event.”

The group also note, “The memo asserts, incorrectly, that ‘we do not have reliable data’ on the benefits of Covid vaccination in children.”

On his post on X, Cassidy wrote, “FDA has not published any data around the alleged deaths or explained the process they took to verify it. I’ve asked FDA for a full briefing on this. The American people deserve clarity. Withholding this critical information is not radical transparency and will worsen confusion and fear among patients and parents.”