> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Experts Criticize New FDA Vaccine Skepticism Memo - URL: https://www.fdaweb.com/experts-criticize-new-fda-vaccine-skepticism-memo/ - Published: 2025-12-01T12:00:00.000Z - Updated: 2026-09-14T15:27:56.000Z - Author: David McFarland - Tags: Biologics, #legacy-id-D5160296 Leading vaccine experts are sharply criticizing a newly revealed FDA memo that claims ten children died “after and because of” receiving Covid-19 vaccines between 2021 and 2024\. The memo, written by CBER director **Vinay Prasad** and obtained by several media outlets, states that the deaths were drawn from reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a public, unverified database that accepts reports from anyone, including clinicians, patients, and family members. VAERS reports alone do not establish causality, the experts note. Pediatrician and Vaccine Education Center director at Children’s Hospital of Philadelphia **Paul Offit**, who previously served on FDA’s vaccine advisory committee, said the memo provides no evidence to support the conclusions it draws. “If you’re going to make that kind of extraordinary claim, you should have clear evidence,” he told MSNOW in an interview. He noted that, at minimum, investigators would need detailed autopsy findings demonstrating severe myocarditis directly linked to vaccination, proof that the children were not infected with SARS-CoV-2 — which itself can cause fatal myocarditis — or with other viruses known to cause the condition. News outlets have reported that the memo does not include the children’s ages, medical histories, timelines, documentation, or information about which manufacturer’s vaccine was used. The findings have also not been published in a peer-reviewed journal. Offit called FDA’s handling of the issue “unprofessional and irresponsible,” saying that proper procedure would require writing up detailed case reports, submitting them for peer review, and having independent subject-matter experts evaluate the claims. “Here we just have the FDA saying, ‘trust us,’” he said. The memo suggests the deaths were tied to myocarditis, an inflammatory condition of the heart muscle. Offit explained that while SARS-CoV-2 infection can occasionally cause severe or fatal myocarditis in children, myocarditis linked to Covid-19 vaccination has been documented primarily in males ages 16 to 29 and has typically been mild and short-lived. “What the FDA is now claiming is that in some children it was so severe it caused death,” he said. “If that’s true, prove it.” NBC News medical analyst **Vin Gupta** also said FDA has provided no actual evidence at this time to back up the agency’s claim. “What concerns me is that, you know, time and time again from RFK Jr. \[HHS secretary **Robert F. Kennedy Jr**.\] and his deputies is a consistent understatement of what Covid actually does to bodies, especially the bodies of children.” He cited a recent research study published in *The Lancet*, “showcasing that the risk of infection to children, causing clots, causing other inflammatory processes in the body, can last for up to a year after a diagnosis of Covid in a child five months to 18 years of age versus that risk from the vaccine, which is far less. But we don't talk about that. Gupta hinted that sowing doubt in vaccines will lead to fewer vaccinations by the public. He said the CDC estimates about 120,000 hospitalizations across the U.S. were averted last year because of the flu vaccine. “That's a big deal for those of us that practice in intensive care units,” he said. “Where are these patients going to go? Otherwise, more and more patients will flood hospitals, and so that’s the real-world impact.” The FDA memo suggests they want more evidence, more real-world outcomes data, “but we already have that,” Gupta said. In his memo to FDA staff, Prasad warned that the findings constitute “a profound revelation” and states FDA will implement stricter standards for vaccine development and approval. According to reporting, proposed changes include: - Requiring larger, more comprehensive clinical trials — including subgroups such as pregnant women — before approval. - Demand that vaccines, like pneumonia or pneumococcal vaccines, demonstrate they reduce actual disease incidence rather than simply raise antibody levels. - Reevaluating the framework for annual vaccines (such as flu shots) and possibly discouraging administration of multiple vaccines at the same time. - Overhauling vaccine labeling, tightening safety standards, and generally raising the bar for vaccine approval and maintenance. Prasad reportedly told staff that internal dissent would not be tolerated: those who could not accept the new “core principles and operating principles” were asked to submit resignations. The changes come as CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting this week to review the routine childhood vaccine schedule. Offit said he has little confidence in the deliberations. He noted that in June, RFK Jr. dismissed 17 members of ACIP and replaced them with individuals who share his skepticism of vaccines. “One of the new members has said he is proud to be an anti-vaccine activist,” Offit said. “Most people in the medical and scientific community can no longer look to ACIP or the CDC for valid information and advice.” Despite the turmoil, Offit said medical organizations and academic centers are working to provide clear, evidence-based information to families. Groups including the American Academy of Pediatrics, the Infectious Diseases Society of America, and hospital-based vaccine education programs have stepped in to help fill the void.“It’s more work than is necessary,” Offit said, “but the country has risen up in many ways to provide the information we need.”