{"id":22515,"date":"2025-05-01T16:17:26","date_gmt":"2025-05-01T16:17:26","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/kennedy-issues-demands-for-vaccine-approvals-that-could-affect-fall-covid-boosters\/"},"modified":"2025-05-01T16:17:26","modified_gmt":"2025-05-01T16:17:26","slug":"kennedy-issues-demands-for-vaccine-approvals-that-could-affect-fall-covid-boosters","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/kennedy-issues-demands-for-vaccine-approvals-that-could-affect-fall-covid-boosters\/","title":{"rendered":"Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Health Secretary Robert F. Kennedy Jr. announced a plan that would require placebo-controlled studies for all new vaccines, surprising some experts who noted that such testing already routinely takes place.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In a statement, Andrew Nixon, a spokesman for the Department of Health and Human Services, said that \u201call new vaccines will undergo safety testing in placebo-controlled trials\u201d before approval, and called the move a \u201cradical departure\u201d from existing standards.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Modern studies tend to use placebos. One exception has been the Covid booster shots, which have been authorized without human trials to target new strains of the virus as it has evolved. It\u2019s unclear how the announcement will affect availability of Covid vaccines that were expected to be updated for the fall.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mr. Kennedy also announced an effort Thursday for the National Institutes of Health to turbocharge the development of new inoculations for Covid, bird flu and seasonal flu.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The new vaccine development initiative would involve methods other than the mRNA technology used to develop the dominant Covid vaccines that are already in use, a statement from the Health and Human Services department said. The mRNA shots have been the subject of conspiracy theories, and Mr. Kennedy has intensely criticized them.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Taken together, the moves suggest that Mr. Kennedy will reach far into the details of vaccine development, an effort likely informed by his decades as one of the nation\u2019s most vocal critics of immunization oversight.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Though some scientists say the quest to fully understand the possible unanticipated effects of vaccines is worthwhile, they also warn that doing so in a way that delays approval of lifesaving shots could jeopardize public health.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mr. Kennedy\u2019s activism in recent years included <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2025\/01\/17\/health\/rfk-jr-covid-vaccines.html\" title=\"\">petitioning the Food and Drug Administration<\/a> to pull the Covid vaccine off the market in 2021, during a deadly phase of the pandemic. He also urged the F.D.A. not to authorize Covid shots for children.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Asked about how the new testing policy would affect Covid booster shots, Mr. Nixon suggested that new trials could be requested. Though the vaccines authorized by the F.D.A. were initially studied in large trials against placebos, Mr. Kennedy and others have criticized the lack of clinical trials for the boosters.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cAs we\u2019ve said before, trials from four years ago conducted in people without natural immunity no longer suffice,\u201d Mr. Nixon said. \u201cA four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years. The public deserves transparency and gold-standard science \u2014 especially with evolving products.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Pfizer and Moderna, makers of the mRNA Covid shots, did not respond immediately to requests for comment. The Washington Post first reported the policy shift.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Ofer Levy, a Harvard vaccine researcher and a member of the F.D.A.\u2019s vaccine advisory committee, said exploring possible unexpected effects from vaccines would be a valuable effort. But he said officials must \u201cthread the needle\u201d to be sure it is done in a way that did not leave older and immunocompromised people unprotected from Covid.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He said that leaving a group taking the placebo vulnerable to Covid posed ethical concerns that would need to be carefully considered. Holding up authorization for updated Covid shots would be \u201cunacceptable,\u201d he said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cTens of thousands of people can die without protection against Covid,\u201d said Dr. Levy, who co-founded a company working on an opioid vaccine.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-3\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The Centers for Disease Control and Prevention reported about 23,000 deaths from Covid since September, with as many as 1,000 a week that month and in January. Still, uptake of the Covid boosters has been low: About 23 percent of adults got the updated Covid shot released in the fall, <a class=\"css-yywogo\" href=\"https:\/\/www.cdc.gov\/covidvaxview\/weekly-dashboard\/index.html\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">according to the C.D.C.<\/a><\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mr. Kennedy\u2019s familiarity with the issue stems at least in part from his reviews of decades-old vaccine approvals, including for the polio vaccine and the measles, mumps rubella vaccine. He has also helped represent plaintiffs in lawsuits against manufacturers.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He and the organization he founded and once led, Children\u2019s Health Defense, have <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2023\/04\/17\/us\/politics\/robert-f-kennedy-jr-vaccines.html\" title=\"\">repeatedly complained<\/a> that vaccines are not tested against placebos in clinical trials when they are being developed. The organization has cited polio, hepatitis and meningitis vaccines as examples, all vaccines that were introduced decades ago.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cEvery other medicine is tested against a placebo,\u201d Mr. Kennedy said on <a class=\"css-yywogo\" href=\"https:\/\/www.youtube.com\/watch?v=zyxEo2kqo08\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">a podcast in January 2020,<\/a> in claiming that vaccines are exempt from that requirement.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">That, however, is not entirely correct. Cancer drugs and other medications authorized under the F.D.A.\u2019s accelerated approval program are regularly authorized after trials without a placebo. And new vaccines, including the vaccines for Covid, were tested against placebos \u2014 inert substances, such as a saline injection, or in some cases against vaccines for other diseases.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-4\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">But new formulations of already approved vaccines are compared to those in existing vaccines in clinical trials, because it would be considered unethical to withhold effective vaccines from patients, including infants.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cWe\u2019ve required placebo-controlled trials for most vaccines, and sometimes it\u2019s an inert placebo, and sometimes it\u2019s an irrelevant vaccine,\u201d said Dr. Peter Marks, who was the Food and Drug Administration\u2019s top vaccine official until he <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2025\/03\/28\/health\/fda-vaccines-rfk-jr-peter-marks.html\" title=\"\">was forced out<\/a> in March. \u201cThe claim that we have not done randomized trials for pediatric vaccines aside from Covid is not correct.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mr. Kennedy has also raised concerns in the past about testing a vaccine against what many consider a reasonable placebo: the same formula, but without the immune-activating agents. Mr. Kennedy has noted that the practice leaves uncertainty about whether ingredients in the formula could cause harm.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The announcement that the National Institutes of Health will develop new technology for making flu and coronavirus vaccines to prevent against pandemics appears aimed at displacing the mRNA vaccine technology that has been a target of critics, including the health secretary.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">This \u201cnext-generation vaccine platform\u201d would be \u201cfully government-owned,\u201d the department said. The N.I.H. helped develop the mRNA platform, and the vaccine maker Moderna <a class=\"css-yywogo\" href=\"https:\/\/www.fiercepharma.com\/pharma\/moderna-pays-us-government-400m-catch-payment-under-new-covid-19-vaccine-license\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">paid the government<\/a> hundreds of millions of dollars to license a key patent on the vaccine, though the company and the government <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2021\/11\/09\/us\/moderna-vaccine-patent.html\" title=\"\">later got into a dispute<\/a> over the patent rights.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-5\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The mRNA platform relies on small bits of genetic code, which generated <a class=\"css-yywogo\" href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8115834\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">online rumors and conspiracy<\/a> theories that it was being used to insert microchips into vaccine recipients. The new platform, by contrast, would rely on a more traditional method of vaccine development, which uses inactivated viruses to provoke an immune response.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The department said the new platform would be developed using <a class=\"css-yywogo\" href=\"https:\/\/www.epa.gov\/sites\/default\/files\/2016-09\/documents\/beta-propiolactone.pdf\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">beta-Propilactone,<\/a> which is already a component in vaccine development but is considered a hazardous substance by the Environmental Protection Agency when people are exposed to it in large doses.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.nytimes.com\/2025\/05\/01\/us\/rfk-jr-vaccine-safety-placebos-covid.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Health Secretary Robert F. Kennedy Jr. announced a plan that would require placebo-controlled studies for all new vaccines, surprising some<\/p>\n","protected":false},"author":1,"featured_media":22516,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[934,114,139,1642,915,5119,551,5120,931,219,6664,916,932,626,113,624],"class_list":["post-22515","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-2","tag-clinical-trials","tag-donald-j","tag-drugs-pharmaceuticals","tag-immune-system","tag-kennedy","tag-marks","tag-medicine-and-health","tag-peter-w","tag-placebos","tag-regulation-and-deregulation-of-industry","tag-rna-ribonucleic-acid","tag-robert-f-jr","tag-rumors-and-misinformation","tag-tests-medical","tag-trump","tag-vaccination-and-immunization"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters - World News<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/site.itshrt.com\/worldnews\/kennedy-issues-demands-for-vaccine-approvals-that-could-affect-fall-covid-boosters\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters - World News\" \/>\n<meta property=\"og:description\" content=\"Health Secretary Robert F. 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