Leaked internal FDA emails suggest the agency may set stricter rules for vaccine approval in the near future<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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THURSDAY, Dec. 11, 2025 (HealthDay News) \u2014 Federal officials say the U.S. Food and Drug Administration (FDA) is reviewing reports of possible deaths in adults and children following COVID-19<\/a> vaccination.<\/p>\n \u201cFDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to coronavirus vaccines,\u201d said Andrew Nixon<\/a>, spokesperson for the U.S. Department of Health and Human Services (HHS).<\/p>\n The review follows a leaked email<\/a> from Dr. Vinay Prasad<\/a>, who leads the FDA\u2019s vaccine division. In the email, Prasad wrote that the agency had identified \u201cat least 10 children\u201d who died \u201cafter and because of\u201d COVID-19 vaccination, but he didn’t provide details.<\/p>\n Public health experts have since asked the FDA to release data showing how those conclusions were reached.<\/p>\n COVID vaccines have been studied widely and have shown a strong safety record, with known side effects listed on their labels.<\/p>\n Prasad\u2019s email also suggested the FDA may set a higher bar for vaccine approval, requiring companies to show that vaccines prevent disease after they reach the market, rather than simply generating infection-fighting antibodies.<\/p>\n A group of 12 former FDA commissioners wrote last week in The New England Journal of Medicine<\/a><\/em> that these proposed changes could weaken the nation\u2019s ability to respond to infectious disease threats.<\/p>\n Under U.S. Health Secretary Robert F. Kennedy Jr.<\/a>, HHS statements have questioned the safety of mRNA COVID-19 vaccines, The Washington Post<\/em> reported.<\/p>\n Nixon said health officials \u201cwill soon release documents laying out that framework and data confirming how the coronavirus vaccine resulted in children\u2019s deaths that previous leadership failed to properly investigate.\u201d<\/p>\n Meanwhile, the FDA has contacted multiple companies, including Merck<\/a>, Sanofi<\/a> and AstraZeneca<\/a>, regarding the safety of RSV monoclonal antibodies used to protect infants against respiratory syncytial virus. It\u2019s a common infection that infects the nose, throat and lungs.<\/p>\n Merck met with the agency last week and said it is \u201cconfident in the safety profile\u201d of its RSV product, Enflonsia<\/a>, The Post<\/em> said.<\/p>\n Sanofi, whose RSV preventive treatment Beyfortus<\/a> has been given to more than 400,000 infants in trials and real-world studies, stated that \u201cno safety issue has been identified.\u201d<\/p>\n More information<\/strong><\/p>\n The U.S. Centers for Disease Control and Prevention has more on COVID vaccines<\/a>.<\/p>\n