Authored by Aldgra Fredly via The Epoch Times (emphasis ours),
The U.S. Food and Drug Administration (FDA) is looking into the potential links between COVID-19 vaccination and deaths in various age groups, according to the Department of Health and Human Services (HHS).
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.
Prasad criticized common assertions that COVID-19 infection posed a greater myocarditis risk than vaccination, saying that this claim is wrong, that existing studies use “a false denominator,” and fail to evaluate risk-benefit trade-offs for healthy adolescents and young adults.
“Finally, the FDA has failed to properly enforce many required post market commitments for COVID-19 vaccines, including for pregnant women and to document subclinical myocarditis,” he wrote.
Prasad said that CBER will take swift action on the safety concerns and will no longer grant marketing authorization for vaccines in pregnant women based on “unproven” surrogate antibody endpoints.
He added that the agency will shift vaccine regulation toward evidence-based standards and revise its annual flu vaccine framework.
Tom Ozimek, Zachary Stieber and Reuters contributed to this report.
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