pandemic

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.