Director of the FDA’s Center for Biologics Evaluation and Research, Dr Vinay Prasad , told agency staff in a memo that at least ten children died ‘after and because of receiving’ the Covid-19 vaccine.The 3,000-word memo, obtained by NBC News, was authored by Dr Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research. It claims that agency staff determined “no fewer than 10” of 96 child deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 were linked to Covid vaccines. Prasad suggested myocarditis, an inflammation of the heart muscle, as a possible cause but provided no supporting evidence. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” he wrote in an email to staff. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it”, he added.The memo did not detail the children’s ages, medical histories, timelines, or the vaccine manufacturer, and the findings have not been peer-reviewed.Dr Paul Offit, a paediatrician and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told NBC News: “This is sort of science by press release,” calling the memo “irresponsible” and “dangerous.”Dr Peter Marks, former FDA vaccine chief, criticised the agency’s handling of the data, saying the claims were drawn from what he described as the “anti-vaccine playbook.” Marks told The Guardian that the memo’s “clearly political tone” was alarming and noted that establishing causation in child deaths is complex. He added that VAERS is intended to detect early safety signals, not to confirm vaccine-related deaths.Dr Kathryn Edwards, professor emeritus at Vanderbilt University, said determining whether a vaccine caused death requires autopsies and careful review of other causes. She stressed that Covid itself has caused far more child deaths than those cited in the memo.Prasad’s memo also proposes sweeping changes to FDA vaccine evaluation, including revisiting flu shot assessments, requiring post-market proof of pneumonia vaccine effectiveness, and reconsidering co-administration of multiple vaccines. Experts warn these changes could slow approvals, delay product launches, and disrupt established immunisation schedules.The memo comes after the FDA and CDC limited Covid vaccine eligibility this winter to adults over 65 and those with underlying medical conditions.Previous research supports vaccine safety: a 2023 JAMA Pediatrics study of over 10 million children aged 5–11 found vaccination reduced infection and hospitalisation risk, while a 2024 Nature Communications study reported no rise in serious adverse events, noting only a very small risk of myocarditis in teen boys.
