FDA Report Links Potential Risks to COVID Vaccines in Children, Sparks Debate
Washington D.C. – A leaked internal memo from the Food and Drug Administration (FDA) has ignited controversy after suggesting a potential link between COVID-19 vaccines and the deaths of at least ten children, according to reports. The memo also raises concerns about whether vaccine mandates may have caused more harm than good, particularly for healthy young children.
The document states: “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.” It further reads: “It is horrifying to consider that the U.S. vaccine regulation, including our actions, may have harmed more children than we saved,” while acknowledging the agency “does not have reliable data estimating the absolute benefit” of vaccine receipt.
The claims within the memo have been swiftly challenged by leading medical experts. Dr. Krutika Kuppalli, vice chair of the IDSA Global Health Committee and clinical professor at Stanford University, wrote on X: “There is NO evidence linking COVID-19 vaccines to deaths in children. There IS evidence that COVID causes serious harm-including long COVID, MIS-C, cardiac complications and diabetes. This administration’s actions are dangerous, and the damage to the public and children might potentially be irreversible.”
Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, criticized the FDA’s announcement as “irresponsible,” telling Newsweek the agency needs to “push forward the data that backs up” it’s claim. He emphasized the difficulty in establishing a definitive link, stating the need for autopsy data confirming myocarditis as the cause of death, evidence of an immune response specifically to the SARS-CoV-2 spike protein (and not prior infection), and ruling out other viral causes of myocarditis.
FDA chief medical and scientific officer Vinay Prasad acknowledged the overall benefits of vaccines but cautioned against a blanket approach, stating, according to CNN: “I have no doubt that manny vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product. The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm.”
Lucky Tran, director of science communications at Columbia university, posted on X, calling the memo “reckless,” and stating: “This is so reckless. The science shows us that COVID vaccines have saved millions of lives.”
The FDA has not yet detailed how thes concerns will impact its vaccine approval process moving forward. The situation remains fluid as the agency faces mounting pressure to substantiate its claims and address the growing concerns surrounding vaccine safety and efficacy.
