\u201cIn many cases, such mandates were harmful,\u201d Prasad wrote. \u201cIt is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.\u201d<\/p>\n
Prasad and representatives of the the Department of Health and Human Services, which oversees the FDA, did not respond to a detailed request for comment.<\/p>\n
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\t\t\t\t It is unclear what the FDA\u2019s next steps will be. The memo does not contain any information on plans to release more detailed information on the deaths or to publish the result in a medical journal. Prasad said the agency would require more definitive data for vaccines administered during pregnancy and that he plans to reform the way that annual influenza vaccines are regulated. He also stated that the FDA may look at whether multiple shots should be given at once, a concern that could disrupt the childhood vaccine schedule.<\/p>\n \u201cThe talk about purported danger of combined vaccines or multiple vaccines given at same visit is concerning if applied to ban or un-recommend combo vaccines, or require spacing-out in a way that greatly reduces uptake and done without evidence of harm,\u201d said Jeffrey Morris, a professor of public health and preventive medicine at the University of Pennsylvania.<\/p>\n It was not clear which vaccines Prasad was talking about in many of his comments, such as those related to vaccines given during pregnancy.\u00a0<\/p>\n Outside experts said they would need much more evidence to understand whether it had been established that the Covid vaccine caused deaths in children. They said it was surprising that more data were not included in the memo, which they viewed as certain to be made public. Some claims in the memo, such as the implication that the federal government sets school vaccine mandates, are incorrect.<\/p>\n \u201cIt\u2019s irresponsible science at best and it\u2019s dangerous to the public at the very least,\u201d said Michael Osterholm, director of the University of Minnesota\u2019s Center for Infectious Disease Research and Policy. Osterholm said the FDA should refer the question of whether there was a causal link between Covid vaccination and the deaths Prasad identified to the National Academies of Sciences, Engineering, and Medicine for independent review.<\/p>\n Several CBER staff members who work with vaccines, and who were granted anonymity for fear of repercussions, told STAT they were upset over what they called a \u201cmisleading\u201d and \u201cpolitically charged\u201d email. One worried a team member would ask to be moved to another center.<\/p>\n \u201cJumping from these case reports to their preexisting vaccine policy preferences is awfully convenient,\u201d said another employee.<\/p>\n Paul Offit, a professor at Children\u2019s Hospital of Philadelphia, the co-developer of a vaccine for rotavirus, and a longtime critic of HHS Secretary Robert F. Kennedy Jr., said it was \u201cfrustrating\u201d to respond to a document when it was unclear exactly what vaccine policy is being proposed. \u201cIt is a lot of vague handwaving.\u201d\u00a0<\/p>\n \t\t\t \t\t\t\t Prasad states there are data, but \u201che doesn\u2019t show the data,\u201d Offit said. He added: \u201cIt\u2019s an extraordinary claim and should be backed by extraordinary evidence.\u201d<\/p>\n Jesse Goodman, who led CBER during the George W. Bush administration, said the memo was \u201cdestined to go externally,\u201d given that it was emailed to the entire center. \u201cWhen you send a letter to a thousand people or more, this is a really extraordinary claim that would normally merit a very detailed scientific analysis and presentation at an appropriate forum.\u201d<\/p>\n Without the data that such an analysis would contain, Goodman said, it was difficult to know what to make of Prasad\u2019s assertion.<\/p>\n In the memo, Prasad noted that he and FDA Commissioner Marty Makary had written two widely discussed journal articles<\/a>, one with Tracy Beth H\u00f8eg<\/a> \u2014 who is now a senior adviser for clinical sciences at CBER \u2014\u00a0prior to joining the agency. Those articles criticized the way that the FDA and the Centers for Disease Control and Prevention handled early evidence that the mRNA Covid vaccines \u2014 the shots made by Moderna and Pfizer\/BioNTech \u2014 increased the risk of an inflammation in the heart called myocarditis in adolescents and young men.<\/p>\n Prasad said that this summer H\u00f8eg began investigating reports to the Vaccine Adverse Event Reporting System (VAERS) of children who had died after the administration of the Covid-19 vaccine. By late summer, he wrote, H\u00f8eg had concluded \u201cthat there were in fact deaths\u2013 a fact this agency had never publicly admitted.\u201d<\/p>\n STAT had previously reported on H\u00f8eg\u2019s work<\/a> and of the objections of some FDA staff to her methods.<\/p>\n VAERS is an early warning system that tracks reports from physicians and members of the public of what might be vaccine side effects, but it is used cautiously by experts because such reports can be unreliable.<\/p>\n Prasad said he asked the FDA\u2019s Office of Biostatistics and Pharmacovigilance to look at 96 deaths between 2021 and 2024 that were reported to VAERS. Of these, he wrote, \u201cno fewer than 10 are related\u201d to receipt of Covid shots. He wrote that the team was conservative in assigning blame, and that \u201cthe real number is higher.\u201d<\/p>\n But vaccine experts, including those who had served on important advisory committees or in regulatory roles in the past, worried that it would be difficult to make such a firm conclusion.<\/p>\n \t\t\t \t\t\t\t \u201cIt is not clear what process was used for attributing deaths to the vaccine,\u201d said Daniel Jernigan, the former director of CDC\u2019s National Center for Emerging and Zoonotic Infectious Diseases, in a text message. \u201cSome greater transparency is needed.\u201d\u00a0<\/p>\n Jernigan resigned from the CDC in August<\/a> to protest Kennedy\u2019s firing of CDC Director Susan Monarez<\/a>.<\/p>\n Kathyrn Edwards, a professor emerita at Vanderbilt University and a veteran vaccine researcher, ticked off some of the information she\u2019d like to have: \u201cWe don\u2019t know where it\u2019s coming from. We don\u2019t know which vaccines. We don\u2019t know what the time frame was. We don\u2019t know how many of these cases have an autopsy that shows actual cardiac involvement.\u201d<\/p>\n Offit said that if the cases did actually involve myocarditis, which Prasad did not state clearly, one key question would be how well it had been shown that the cases were not caused by viruses other than Covid that can cause the condition, such as adenovirus and parvovirus.<\/p>\n Prasad\u2019s memo also understated the risk Covid posed to children, experts said. Prasad said that children faced \u201ca tremendously low risk of death.\u201d Although they were at lower risk than other age groups, Covid did kill children. A 2023 JAMA paper<\/a> said that during the 12 months ending in July 2022, 821 people aged 19 and under died of Covid, making it the eighth leading cause of death in that age group.<\/p>\n An analysis<\/a> presented at a CDC meeting in June 2021 focused on people aged 12 to 29 \u2014 those at highest risk for myocarditis. In that population, Covid had killed 2,767 since the beginning of the pandemic.<\/p>\n Prasad noted that while Covid is most likely to result in death and hospitalization in older people than in children, myocarditis occurs most often in young, healthy boys and men. In other words, those who bore the side effects, no matter how rare, were also at lowest risk. The FDA-approved package inserts for the mRNA Covid vaccines state that they are associated with 27 myocarditis cases per million doses in males 12 years through 24 years of age, based on analyses of commercial insurance claims \u2014 or about 1 in every 37,000 doses given to adolescent or young adult males.<\/p>\n \t\t\t \t\t\t\t But it is not clear how Prasad is doing the math now, or even what changes may be proposed. Deaths, incidence of Covid-caused autoimmune conditions, and myocarditis due to vaccines all appear to have dropped dramatically since the pandemic. Previous FDA analyses<\/a> have tried to weigh the benefits of the vaccine against the risk of myocarditis.<\/p>\n There has been debate among vaccine experts about exactly how frequently children need boosters, and their risk-benefit profile. Offit has been skeptical of the need to offer annual Covid boosters to healthy children and adults.\u00a0<\/p>\n When called about the memo, Offit invited his 2-year-old granddaughter to say hello to a STAT reporter on the phone, and then noted that he\u2019d recommend she get her primary Covid vaccinations but not an annual booster.\u00a0<\/p>\n But he said that some vaccination was a good idea for those who had not had a confirmed case of Covid, because it clearly prevents hospitalization and death. Offit noted that the CDC\u2019s Advisory Committee on Immunization Practices had seemed likely to advise changing booster recommendations<\/a>, but was disbanded in June by Kennedy<\/a> and replaced with a new, handpicked panel.<\/p>\n Experts saw other issues with Prasad\u2019s reasoning: He criticized the CDC for not seeing the myocarditis signal before Israel, but Israel had an earlier vaccine rollout, a smaller and more geographically concentrated population, and a more digitized health care system. Prasad also called for larger randomized controlled trials of Covid shots for children but did not explain how they could have been done late in the pandemic.\u00a0<\/p>\n Many of the experts who STAT spoke with believed that Prasad had written the memo with the express purpose that it would be leaked. He made note in the lengthy email of the fact that there have been previous leaks from within CBER.<\/p>\n ACIP, the CDC\u2019s key vaccine panel, will meet during the coming week. Goodman said that HHS \u201cbasically removed suitable expertise\u201d when the ACIP committee was reconstituted. \u201cSo I hope the plan isn\u2019t to suddenly dump these cases on the ACIP.\u201d<\/p>\n Prasad took the opportunity in the email to comment on both his willingness to change his mind and his opposition to public leaks.<\/p>\n \u201cI remain open to vigorous discussions and debate on these topics, as I have always been,\u201d he wrote. \u201cI am open minded to modifications or alterations.\u201d<\/p>\n He then emphasized that the debates should be \u201cprivate, internal to FDA, until they are ready to be made public.\u201d<\/p>\n He added: \u201cSome staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor and CC my deputy Katherine Szarama.\u201d<\/p>\n Lizzy Lawrence and Daniel Payne contributed reporting.<\/p>\n","protected":false},"excerpt":{"rendered":"The Food and Drug Administration\u2019s top vaccine regulator asserted in an email to staff sent Friday that the…\n","protected":false},"author":3,"featured_media":414396,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[64,4140,151,1856,153,67,132,68,2857],"class_list":{"0":"post-414395","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-business","8":"tag-business","9":"tag-covid-19","10":"tag-fda","11":"tag-infectious-disease","12":"tag-policy","13":"tag-united-states","14":"tag-unitedstates","15":"tag-us","16":"tag-vaccines"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115636959196775372","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/414395","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=414395"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/414395\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/414396"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=414395"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=414395"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=414395"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"\/](\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/home\/statplus.svg\")
\n\t\t\t\tSTAT Plus: How two top FDA officials are quietly upending vaccine regulations<\/a><\/p>\n![\"\"](\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/11\/AdobeStock_917911475-768x432.jpeg\")
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\n\t\t\t\tSTAT Plus: FDA review staff was excluded from voting on whether to approve first priority voucher drug<\/a><\/p>\n![\"\"](\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/11\/VINAY_ca_01-768x432.jpg\")
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\n\t\t\t\tSTAT Plus: Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits<\/a><\/p>\n![\"\"](\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/11\/AP21309675758063-768x432.jpg\")
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\n\t\t\t\tSTAT Plus: Trump and RFK Jr. are mulling their most disruptive vaccine policies yet \u2014 alarming manufacturers<\/a><\/p>\n