Vinay Prasad, director of the FDA’s Center of Biologics Evaluation and Research, is under scrutiny after a recent report questioned his statements about pediatric deaths linked to COVID-19 vaccines. According to Inside Medicine, Prasad had claimed in late November that there were “at least” 10 deaths among children caused by the vaccines. However, a Dec. 5 memo from FDA scientists suggests that the number is lower.
The agency’s internal review found between zero and seven deaths potentially associated with COVID-19 vaccination. Of these, two were considered “probable/likely” related to the shots, meaning no other likely cause was identified. Five cases were rated as “possible,” indicating that another explanation for death was just as plausible as vaccination. No deaths were classified as “certain” to have been triggered by the vaccines.
This safety review has not yet been made public. The FDA stated earlier this month that it would release data on these deaths in the “near term.” A spokesperson for the Department of Health and Human Services told Inside Medicine: “There’s no final count yet of those deaths.”
Prasad’s original claim was based on findings by Tracy Beth Høeg, who at the time was a senior adviser at the agency and has since become director of the Center for Drugs Evaluation and Review. Høeg used reports from VAERS (Vaccine Adverse Event Reporting System), but according to information on the FDA’s website, VAERS reports generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.
In his internal memo last month, Prasad asserted—without providing evidence—that his figure of 10 deaths was “certainly an understatement.” His comments drew criticism from within regulatory circles. More than a dozen former officials from both the FDA and CDC published an editorial in the New England Journal of Medicine expressing concern over what they described as unsubstantiated safety claims in Prasad’s memo and questioning proposed changes to vaccine regulation.
Despite opposition, reports indicate that the FDA is considering steps such as limiting access to COVID-19 vaccines and adding black box warnings—the agency's most serious safety notice—to their labels.
