<\/p>\n
As the US\u2019s top vaccine officials come under pressure from lawmakers and former leaders, the US Food and Drug Administration (FDA) says it will release information \u201csoon\u201d about changes to regulations following unconfirmed claims of deaths after Covid vaccination.<\/p>\n
It\u2019s part of a sweeping effort, led by Robert F Kennedy Jr<\/a>, secretary of the US Department of Health and Human services (HHS), to change the routine vaccines given in childhood, limiting access to and casting doubt upon safe and effective vaccines.<\/p>\n Vinay Prasad, director of the FDA\u2019s Center for Biologics Evaluation and Research (CBER), announced wide-ranging but vague changes to vaccine regulations in an email to staff<\/a> where he also claimed, with no evidence, that Covid vaccination had killed 10 children.<\/p>\n The ongoing investigation is also focusing on deaths among adults after Covid vaccination, an HHS spokesperson confirmed.<\/p>\n \u201cFDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines,\u201d HHS press secretary Emily Hilliard said in a statement. The agency will release more information \u201csoon\u201d, she said, claiming that \u201cprevious FDA leadership failed to properly investigate\u201d the deaths.<\/p>\n The FDA was previously reported<\/a> to be considering a total of 25 deaths pulled from the Vaccine Adverse Event Reporting System (VAERS) \u2013 a database to which anyone may submit reports.<\/p>\n \u201cWhat I would want to know is, have these not been investigated before? What is different?\u201d asked Debra Houry, former chief medical officer for the US Centers for Disease Control and Prevention (CDC). \u201cI would want to see the data and have them verified.\u201d<\/p>\n The announcement, and the lack of details in the weeks following, represents a major departure from previous FDA priorities to release information immediately about potential safety signals.<\/p>\n \u201cIt remains striking that even this much time has passed without details\u201d or evidence to support the \u201cbombshell\u201d claim, said Jason L Schwartz, an associate professor of health policy and management at the Yale School of Public Health<\/a>. \u201cIt\u2019s so different than anything we would have typically expected if there had been a serious adverse event linked to a vaccine, let alone deaths, let alone deaths that a senior FDA official was saying were because of the vaccine.\u201d<\/p>\n The longer the evidence is delayed, \u201cthe more it raises questions about what\u2019s really under the hood regarding these allegations\u201d, Schwartz said.<\/p>\n Democratic lawmakers on the US House committee on energy and commerce sent a scathing letter<\/a> on Friday to commissioner Marty Makary, expressing \u201ccontinued concern\u201d over the FDA\u2019s role in \u201cundermining our nation\u2019s vaccine infrastructure\u201d. The letter decried a lack of transparency from federal officials and the inability for the public to comment on new regulatory approaches.<\/p>\n All 12 former heads of the FDA blasted Prasad\u2019s moves as a \u201cthreat to evidence-based vaccine policy and public health security\u201d last week in a commentary<\/a> for the New England Journal of Medicine.<\/p>\n