The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
Vinay Prasad, director of the FDA’s Center of Biologics Evaluation and Research, appears to have exaggerated his claims of pediatric deaths caused by COVID-19 vaccines, according to a Friday report from Inside Medicine.
Citing a Dec. 5 memo from the agency’s scientists, the Substack publication reported that there were anywhere from zero to seven deaths linked to COVID-19 shots—lower than Prasad’s initial claim of “at least” 10 mortalities in late November. Whereas the director concluded that the deaths were “because of” the vaccines, the scientists’ findings were less definitive about causation.
The scientists’ review of postmarket safety data found that two deaths were “probable/likely” related to the shots, indicating that the staffers found no other likely reason for the deaths, according to Inside Medicine. Meanwhile, five were given the rating “possible,” meaning that there was another explanation of the death that was just as plausible as vaccination.
Zero deaths were classified as “certain” to have been triggered by the vaccines in the internal review.
This safety review has yet to be made public. In a statement earlier this month, the FDA said that it would reveal the data pointing to these deaths in the “near term.” In a statement to Inside Medicine, a spokesperson for the Department of Health and Human Services said that the regulator is continuing to look into deaths linked to COVID-19 vaccines. “There’s no final count yet of those deaths,” the spokesperson added.
In Prasad’s internal memo late last month, he claimed—without providing evidence—that the 10 deaths he cited were “certainly an understatement.” The deaths were uncovered by Tracy Beth Høeg, then a senior adviser at the agency, who dug into the FDA’s Vaccine Adverse Event Reporting System (VAERS) for safety reports on the vaccines. According to the FDA’s own website, VAERS “generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.”
Høeg has since been named director of the Center for Drugs Evaluation and Review.
Prasad’s memo was met with a strong backlash from his fellow regulators. Earlier this month, more than a dozen former officials from the FDA and CDC wrote an editorial for the New England Journal of Medicine, raising concerns about the unsubstantiated safety claims in the memo and Prasad’s proposed changes to the vaccine regulatory framework. Prasad suggested in the memo that such changes were in the works.
Despite the pushback, the FDA appears to be moving forward with plans to curtail access to these vaccines and is reportedly looking to add black box warnings—its most severe safety flag—to the labels of COVID-19 vaccines.
