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FDA Investigating Deaths Potentially Linked To COVID-19 Vaccines Across Age Ranges
The FDA investigation is being carried out as part of a safety review, a HHS spokesperson said on Dec. 9.
The probe follows a Nov. 28 memo by Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), which revealed that COVID-19 vaccines were likely implicated in the deaths of at least 10 children.
The spokesperson did not provide details on which age groups will be covered or what criteria the FDA will use to determine which cases fall within the scope of the investigation.
Data published by the World Health Organization showed that more than 700 million COVID-19 vaccine doses have been administered in the United States since December 2020.
The Epoch Times reached out to the HHS for further comment, but did not hear back by publication time.
Prasad said in the memo that the findings were based on a review of 96 death reports voluntarily submitted to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024. The memo did not disclose the health conditions of the children or the vaccine manufacturers involved.
"If anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher," he stated in the memo. "This is a profound revelation."
Prasad, head of the FDA's Center for Biologics Evaluation and Research, was one of the early opponents of keeping COVID-19 vaccines available for younger people. He has has supported COVID-19 vaccination for seniors and younger people with underlying conditions.
The investigation was spurred by concerns that the previous administration misled the public about harms COVID-19 vaccines can cause, including myocarditis, or heart inflammation, Prasad indicated in the memo.
The memo states that the FDA never required manufacturers to demonstrate—through randomized controlled trials—that vaccinating children reduced hospitalization or death. Available data, Prasad wrote, are deeply limited, rely on methods with notorious biases, and fail to establish whether the vaccine saved more children than it harmed.