The regulator is still investigating “additional adverse event cases,” a spokesperson told Endpoints News on Wednesday.
The FDA will not soon provide data to back the claim from Vinay Prasad, director of the Center for Biologics Evaluation and Research, that 10 children have died because of COVID-19 vaccination.
In a statement to Endpoints News, which broke the news on Wednesday, a spokesperson said that the FDA will not be releasing details regarding the claim in the “near term” because it is still investigating “additional adverse event cases.” The spokesperson later followed up, adding that the agency plans to “make a report publicly available by the end of this month that covers the reported 10 deaths.”
BioSpace has reached out to the FDA for independent confirmation of the news.
Last week, Prasad sent an internal memo to FDA staff claiming that “at least 10 children have died after and because of receiving COVID-19 vaccination.” Newly appointed acting director of the Center for Drug Evaluation and Research, Tracy Beth Høeg, as well as an internal team at CBER, analyzed 96 reported deaths occurring from 2021 to 2024 and found that “no fewer than 10” mortalities are “related” to the shots. This number, Prasad continued in his memo, “is certainly an underestimate due to underreporting.”
Experts were quick to blast Prasad’s memo and question the veracity of his claims. “After years of working at the FDA I’ve never seen a memo like that,” Peter Lurie, who previously served as an associate commissioner at the agency, told BioSpace earlier this week.
Meanwhile, Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told BioSpace that “when you make a sensational claim like that, a frightening claim like that, at the very least, you owe it to the public to provide the evidence.”
In his memo, Prasad revealed only that these alleged mortality signals were picked up by the FDA’s Vaccine Adverse Event Reporting System (VAERS), a public monitoring mechanism that can receive reports from “all concerned individuals, including doctors, vaccine manufacturers and even the public. The VAERS “generally cannot be used to determine if a vaccine caused or contributed to an adverse event or illness,” the FDA itself notes on its website.
Høeg was named as Prasad’s counterpart at CDER only days after news of the memo was made public. She succeeds Richard Pazdur, who earlier this week announced his retirement from the agency after just weeks leading CDER. Pazdur has been with the FDA since 1999.
