The Food and Drug Administration will be investigating whether COVID-19 vaccines are linked to deaths in adults as well as children after a leaked memo suggested the shots killed several kids.
Andrew Nixon, a spokesman for the Department of Health and Human Service, confirmed to multiple outlets that there will be a “thorough investigation across multiple age groups.”
The leaked November memo from Dr. Vinay Prasad, the FDA’s top vaccine regulator, informed staff members that about 10 children’s deaths had been linked to COVID shots.
“Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death,” the memo read, per CNN.
No details were provided about the deaths or how the FDA investigated, but an “initial analysis” examined around 96 deaths and linked 10 to the vaccine. Prasad also said COVID-19 “was never highly lethal for children” and compared it to respiratory viruses.
FDA requires health care providers to report any deaths after vaccination to the Vaccine Adverse Event Reporting System, even if it’s not clear that receiving the vaccine was the cause of death, according to CNN.
Twelve former FDA commissioners responded to the memo in the New England Journal of Medicine, saying the changes “undermined the public interest.”
“We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective and available when the public needs them most,” the former commissioners wrote. “The proposed new directives are not small adjustments or coherent policy updates. They represent a major shift in the FDA’s understanding of its job.”
Prasad said as a result of the findings the agency would adopt a new approval process for vaccines that will require more evidence of their safety and value before they can be marketed.
In October, the Centers for Disease Control and Prevention updated its immunization schedule, removing the COVID-19 vaccine as a recommended shot.
Instead, the CDC is advising “individual-based decision making” when determining whether to get the shot. Changes were made to accommodate recommendations by the CDC’s Advisory Committee on Immunization Practices.
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