{"id":2030614,"date":"2023-09-13T13:58:01","date_gmt":"2023-09-13T17:58:01","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone\/"},"modified":"2023-09-13T14:01:28","modified_gmt":"2023-09-13T18:01:28","slug":"fda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone\/","title":{"rendered":"FDA Approves COVID-19 Boosters Without Trials: Dr. Robert Malone"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">18<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Ffda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2030614&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><div data-post-content=\"true\" class=\"post_content\" id=\"post_content\">\n<p>With its decision to recommend the latest \u2063batch of COVID-19 boosters without clinical trials attesting to efficacy and safety, the Food \u2064and Drug Administration (FDA)\u2064 has &#8220;gone rogue,&#8221; according to virologist Dr.\u2062 Robert Malone,\u2063 who accused the federal \u200cagency of\u200c sacrificing its own rules and regulations on the altar of blind vaccine \u200denthusiasm.<\/p>\n<div class=\"my-5\">\n<h3>Dr. \u2063Malone&#8217;s Concerns<\/h3>\n<p>Dr. Malone made the \u2064remarks in an <a href=\"https:\/\/www.theepochtimes.com\/epochtv\/can-a-public-emergency-strip-our-constitutional-rights-5489852\" target=\"_blank\" rel=\"noopener\">interview with<\/a> EpochTV&#8217;s &#8220;Crossroads&#8221; program on Sept. 11, the\u200c day that the FDA cleared\u2062 new COVID-19 vaccines in a bid to counter the waning effectiveness of the currently available shots.<\/p>\n<\/p><\/div>\n<p>&#8220;It&#8217;s difficult to conclude anything other than the FDA is no longer feeling\u2062 bound\u200d by their own rules and regulations,&#8221; Dr. Malone said. &#8220;The term is\u2014they&#8217;ve gone \u2063rogue.&#8221;<\/p>\n<div class=\"shortcode\">\n<div class=\"border-comp-divider mb-4 mr-4 w-full max-w-[500px] border px-5 py-4 text-[16px] leading-[20px] text-[#262626] md:float-left\" id=\"in_article_related_stories\">\n<div class=\"mb-3 font-sans text-[16px] font-semibold uppercase leading-[19px] text-[#2F2F2F]\">Related Stories<\/div>\n<div class=\"mb-4 flex gap-2\">\n<div class=\"grow\">\n<div class=\"mb-1 line-clamp-2\"><a href=\"http:\/\/www.theepochtimes.com\/us\/city-council-in-texas-votes-to-ban-government-mandated-covid-19-vaccines-lockdowns-5490748\">City Council in \u2064Texas Votes to Ban Government\u200c Mandated COVID-19 Vaccines, Lockdowns<\/a><\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">9\/13\/2023<\/div>\n<\/p><\/div>\n<div class=\"shrink-0 basis-[120px]\"><a href=\"http:\/\/www.theepochtimes.com\/us\/city-council-in-texas-votes-to-ban-government-mandated-covid-19-vaccines-lockdowns-5490748\"><\/a><\/div>\n<\/p><\/div>\n<div class=\"mb-4 flex gap-2\">\n<div class=\"grow\">\n<div class=\"mb-1 line-clamp-2\"><a href=\"http:\/\/www.theepochtimes.com\/article\/cdc-advisers-recommend-new-covid-19-vaccines-for-virtually-all-americans-5490257\">CDC Recommends\u2062 New\u200b COVID-19 Vaccines for Virtually\u2064 All \u2064Americans<\/a><\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">9\/12\/2023<\/div>\n<\/p><\/div>\n<div class=\"shrink-0 basis-[120px]\"><a href=\"http:\/\/www.theepochtimes.com\/article\/cdc-advisers-recommend-new-covid-19-vaccines-for-virtually-all-americans-5490257\"><\/a><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p>Dr. Malone objected \u2063to the lack of clinical trial data on\u2063 humans demonstrating \u200beffectiveness and safety of\u2063 the updated vaccines,\u200b arguing that this should preclude their approval by the\u200d FDA.<\/p>\n<p>He said that,\u200c essentially,\u200b the FDA authorized the new vaccines on the premise that &#8220;neutralising\u200c antibodies as detected in mice and their \u200dcross reactivity are correlative protection,&#8221; which\u200d he said \u2062&#8221;is a lie, there are \u200cno established correlates of protection for SARS-CoV-2.&#8221;<\/p>\n<div class=\"my-5\">\n<h3>FDA&#8217;s Approval<\/h3>\n<p>The FDA, which did\u200c not immediately return a request for comment\u200c for this story from The Epoch Times, approved\u200b Moderna&#8217;s \u2063and Pfizer&#8217;s newest mRNA \u2063vaccines <a href=\"https:\/\/www.theepochtimes.com\/article\/fda-authorizes-new-covid-19-vaccines-in-bid-to-counter-waning-effectiveness-5487196\" target=\"_blank\" rel=\"noopener\">on Monday,<\/a> \u2064despite a lack of data from human clinical trials.<\/p>\n<\/p><\/div>\n<div class=\"shortcode post-related-videos\">\n<div class=\"lazyload-wrapper\">\n<div class=\"lazyload-placeholder\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"my-5\">\n<h2>&#8216;Lot of Red \u2064Flags&#8217;<\/h2>\n<p>&#8220;There&#8217;s essentially \u200dno\u2064 data,&#8221; Florida Surgeon General Dr. Joseph \u2062Ladapo \u2064said at a recent press\u2063 conference in which \u2063he \u2062suggested people might be better\u2063 off passing on\u200c the new round \u2063of\u2062 shots.<\/p>\n<\/p><\/div>\n<div class=\"my-5\">\n<p>&#8220;Not only that, but there\u2064 are a \u200dlot of red flags,&#8221; Dr. \u2062Ladapo added, while pointing to \u200b <a href=\"https:\/\/www.theepochtimes.com\/health\/boosted-people-more-likely-than-unvaccinated-to-be-infected-study-5487833\" target=\"_blank\" rel=\"noopener\">studies<\/a> <a href=\"https:\/\/www.theepochtimes.com\/health\/covid-vaccinated-more-likely-to-be-hospitalized-cdc-data-5335428\" target=\"_blank\" rel=\"noopener\">finding<\/a> that\u200c the effectiveness\u2064 of the vaccines turns negative over time.<\/p>\n<\/p><\/div>\n<p>&#8220;There&#8217;s been \u2064no clinical trial done \u200din human beings\u200d showing that it benefits \u200cpeople, \u200bthere&#8217;s\u200d been no clinical trial showing\u200d that it is a safe product \u200bfor people,&#8221; Dr.\u2063 Ladapo continued.<\/p>\n<p>He also \u2064noted that studies have linked previous versions of the COVID-19 \u2062vaccine to cardiac problems such\u2063 as heart inflammation.<\/p>\n<p>&#8220;It&#8217;s truly irresponsible for\u2062 FDA, CDC, and others to\u200d be championing something &#8230; when \u2063we don&#8217;t \u200dknow the implications of\u200d it,&#8221; Dr. \u2063Ladapo said.<\/p>\n<div class=\"my-5\">\n<h2>&#8216;Most Americans \u2062Take Them&#8217;<\/h2>\n<p>While acknowledging the current vaccines&#8217; waning effectiveness, CDC Director \u2063Mandy Cohen <a href=\"https:\/\/www.nytimes.com\/2023\/09\/13\/opinion\/covid-booster-fall-2023.html\" target=\"_blank\" rel=\"noopener\">penned an \u200dop-ed<\/a> in The New York Times on Sept. 13, in which she called the updated \u200bCOVID-19 vaccines &#8220;one\u2063 of the most \u200beffective tools in combating the virus.&#8221;<\/p>\n<\/p><\/div>\n<p>&#8220;Covid-19\u200c vaccines are the best way to give the body the ability to keep the virus from <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/small-business-group-to-sue-biden-over-vaccine-mandate\/\" title=\"Small Business Group To Sue Biden Over Vaccine Mandate\">causing significant harm<\/a>. Extensive studies and \u2063<a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/sowell-searching\/\" title=\"Sowell Searching\">real-world experience<\/a> have shown that they are safe and they work,&#8221; she continued.<\/p>\n<p>&#8220;And \u200dmost Americans take them,&#8221; she added, suggesting that vaccine uptake popularity under conditions of a \u2063massive propaganda push should be \u200cviewed \u2062as \u2063a\u200c genuine endorsement.<\/p>\n<p>Dr. Cohen said that the vaccines were put through extensive clinical trials before they were introduced in 2021 and &#8220;since then, their safety has \u200cbeen intensely monitored.&#8221;<\/p>\n<p>She did\u200b not address criticism, such as that the updated vaccines\u200c have not been subjected to\u2064 clinical\u200b trials.<\/p>\n<p>In its authorizing \u2062statement, the FDA\u2064 said it&#8217;s &#8220;confident in the safety and effectiveness of these \u200dupdated vaccines\u2064 and the agency&#8217;s <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-has-gone-rogue-by-approving-covid-19-boosters-without-clinical-trials-dr-robert-malone\/\" title=\"FDA Approves COVID-19 Boosters Without Trials: Dr. Robert Malone\">benefit-risk assessment demonstrates<\/a> that the\u2062 benefits \u200cof these\u2064 vaccines for individuals 6 months of age\u200b and older \u2062outweigh\u200c their risks.&#8221;<\/p>\n<div class=\"my-5\">\n<h3>Dr. Offit&#8217;s Perspective<\/h3>\n<p>That FDA endorsement, however, stands in contrast to remarks made by \u2063Dr. \u2064Paul Offit, an FDA adviser, who suggested to the UK&#8217;s <a href=\"https:\/\/www.dailymail.co.uk\/health\/article-12496327\/americans-covid-booster-fda-vaccine.html\" target=\"_blank\" rel=\"noopener\">Daily Mail<\/a> that younger, healthy people who have already\u2064 been vaccinated don&#8217;t need one\u2064 of the new doses.<\/p>\n<\/p><\/div>\n<p>&#8220;We are best served by targeting these booster\u2064 doses to those who are most at risk of \u2063severe disease,&#8221; such\u2062 as people\u2062 older than\u2062 75, Dr. Offit said. &#8220;Boosting otherwise \u200chealthy young people is\u200b a\u200b low-risk, low-reward\u2062 strategy.&#8221;<\/p>\n<p>In\u2063 his remarks\u200d at the\u200c press conference, \u200bDr. Ladapo asked people to make decisions based on their &#8220;resonance of truth&#8221; rather than depending on\u200d &#8220;very educated people telling\u2063 you \u200bwhat \u200byou should think.&#8221;<\/p>\n<p>&#8220;When\u200b they try to convince you to be \u200dcomfortable and agree with \u2063things that\u200d don&#8217;t feel comfortable and don&#8217;t feel\u200d like things\u200b you should agree with, that&#8217;s a sign &#8230; And I encourage\u2062 you and certainly\u2063 beg and hope that you do\u200b listen to it \u200bbecause it will\u200d serve you right,&#8221; he said.<\/p>\n<div class=\"my-5\">\n<h3>Study Findings<\/h3>\n<p>A \u2064January\u2013July 2023 <a href=\"https:\/\/www.theepochtimes.com\/health\/boosted-people-more-likely-than-unvaccinated-to-be-infected-study-5487833\" target=\"_blank\" rel=\"noopener\">study<\/a> that analyzed data from vaccinated individuals found\u2063 that they were more likely \u2063to \u200bbe infected compared\u200d to\u200b those who were unvaccinated.<\/p>\n<\/p><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Dr. Robert Malone, a virologist, criticized the FDA for recommending COVID-19 boosters without clinical trials, stating that the agency has disregarded its own rules and regulations in favor of blind vaccine enthusiasm. He described the FDA&#8217;s decision as going rogue.<\/p>\n","protected":false},"author":2412,"featured_media":2030615,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[543],"tags":[],"class_list":["post-2030614","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-epoch-times"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2030614","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/2412"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2030614"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2030614\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2030615"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2030614"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2030614"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2030614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}