{"id":2024386,"date":"2023-09-07T09:20:01","date_gmt":"2023-09-07T13:20:01","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/exclusive-fda-refuses-to-provide-covid-19-vaccine-safety-data-to-us-senator\/"},"modified":"2023-09-07T09:23:44","modified_gmt":"2023-09-07T13:23:44","slug":"exclusive-fda-refuses-to-provide-covid-19-vaccine-safety-data-to-us-senator","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/exclusive-fda-refuses-to-provide-covid-19-vaccine-safety-data-to-us-senator\/","title":{"rendered":"FDA denies US Senator access to COVID-19 vaccine safety data."},"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\">20<\/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%2Fexclusive-fda-refuses-to-provide-covid-19-vaccine-safety-data-to-us-senator%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=2024386&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>U.S. officials \u200care refusing\u200c to provide COVID-19 vaccine safety data to a U.S. senator.<\/p>\n<div class=\"my-5\">\n<blockquote>\n<p>Sen. Ron Johnson (R-Wis.) <a href=\"https:\/\/www.theepochtimes.com\/us\/exclusive-senator-questions-cdc-on-why-it-expected-hundreds-of-safety-signals-for-covid-19-vaccines-4977690\" target=\"_blank\" rel=\"noopener\">asked<\/a> the U.S. Food and Drug Administration (FDA) for the results of analyses on \u200bdata from the Vaccine Adverse Event Reporting System in January. The \u2064request came \u200dafter the U.S. Centers for Disease \u2063Control and Prevention (CDC) said none of the safety signals\u2063 it identified for the COVID-19 vaccines were\u200d &#8220;unexpected.&#8221;<\/p>\n<\/blockquote><\/div>\n<p>The two agencies have run different types of analyses on the system&#8217;s reports, which are primarily made\u2063 by <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/celebrate-the-truth-politifact-announces-festival-of-fact-checking-with-special-guests-anthony-fauci-and-cnns-brian-stelter\/\" title=\"\u2018Celebrate The Truth!\u2019 PolitiFact Announces \u2018Festival Of Fact-Checking,\u2019 With Special Guests Anthony Fauci and CNN\u2019s Brian Stelter\">health care professionals<\/a>.<\/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<ul class=\"mb-4 flex gap-2\">\n<li class=\"grow\">\n<div class=\"mb-1 line-clamp-2\">\n            <a href=\"http:\/\/www.theepochtimes.com\/us\/fda-cdc-hid-data-on-spike-in-covid-cases-among-the-vaccinated-documents-5483439\">FDA, CDC Hid Data on Spike in \u2063COVID Cases Among the Vaccinated: Documents<\/a>\n          <\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">9\/3\/2023<\/div>\n<\/li>\n<li class=\"shrink-0 basis-[120px]\">\n          <a href=\"http:\/\/www.theepochtimes.com\/us\/fda-cdc-hid-data-on-spike-in-covid-cases-among-the-vaccinated-documents-5483439\"><\/a>\n        <\/li>\n<\/ul>\n<ul class=\"mb-4 flex gap-2\">\n<li class=\"grow\">\n<div class=\"mb-1 line-clamp-2\">\n            <a href=\"http:\/\/www.theepochtimes.com\/health\/fda-is-not-a-physician-appeals-court-sides-with-doctors-on-ivermectin-for-covid-19-post-5485494\">&#8216;FDA Is Not a Physician&#8217;: Appeals\u200c Court Sides With Doctors on Ivermectin for COVID-19<\/a>\n          <\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">9\/2\/2023<\/div>\n<\/li>\n<li class=\"shrink-0 basis-[120px]\">\n          <a href=\"http:\/\/www.theepochtimes.com\/health\/fda-is-not-a-physician-appeals-court-sides-with-doctors-on-ivermectin-for-covid-19-post-5485494\"><\/a>\n        <\/li>\n<\/ul><\/div>\n<\/p><\/div>\n<p>The CDC ran Proportional Reporting Ratio analyses, \u2062which involve comparing the number \u200dof <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/exclusive-florida-surgeon-general-ladapo-we-can-expect-more-of-the-same-and-worse-if-people-dont-speak-up-against-mandates\/\" title=\"Exclusive \u2014 Florida Surgeon General Ladapo: 'We Can Expect More of the Same and Worse' if People Don't Speak Up Against Mandates\">reported adverse events<\/a> to the number of <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/peer-reviewed-cdc-study-deaths-represent-1-3-of-covid-vaccine-side-effects\/\" title=\"Peer Reviewed CDC Study: Deaths Represent 1.3% of COVID Vaccine Side Effects\">adverse events reported<\/a> after vaccination with other vaccines.<\/p>\n<div class=\"my-5\">\n<blockquote>\n<p>The first \u200ctime the\u2063 agency\u2062 ran analyses using the method \u200dfor \u2063the COVID-19 vaccines, in 2022, hundreds of signals were triggered, files obtained by The Epoch \u2062Times\u2063 <a href=\"https:\/\/www.theepochtimes.com\/article\/exclusive-cdc-found-covid-19-vaccine-safety-signals-months-earlier-than-previously-known-files-show-5151506\" target=\"_blank\" rel=\"noopener\">show<\/a>.<\/p>\n<\/blockquote><\/div>\n<p>The FDA in 2021 started a \u200cdifferent type of analysis, called Empirical Bayesian (EB) data mining.<\/p>\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<p>The Proportional Reporting Ratio \u2063results &#8220;were generally consistent with EB data mining, revealing no <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/exclusive-fda-refuses-to-provide-covid-19-vaccine-safety-data-to-us-senator\/\" title=\"FDA denies US Senator access to COVID-19 vaccine safety data.\">additional\u200b unexpected safety signals<\/a>,&#8221; Dr. Rochelle \u200bWalensky, the CDC&#8217;s director\u2062 at \u200bthe time, told Mr. Johnson previously.<\/p>\n<p>Mr. Johnson demanded answers on that claim, prompting the CDC to point him to the \u200cFDA.<\/p>\n<p>The FDA recently responded to Mr. Johnson, telling him that it cannot \u200bprovide the information he seeks.<\/p>\n<p>&#8220;FDA\u2019s EB data mining analyses of adverse events contained in VAERS reports for COVID-19 vaccines \u2062are currently the subject of pending FOIA [Freedom of Information Act] litigation.\u200b FDA is unable to comment on pending litigation or provide information or\u2063 data that is currently being considered in pending litigation,&#8221; the\u2062 agency told the senator.<\/p>\n<div class=\"my-5\">\n<blockquote>\n<p>Mr. Johnson in \u200da \u2063 <a href=\"https:\/\/www.documentcloud.org\/documents\/23940343-sen-johnson-letter-to-fda-on-eb-data-mining\" target=\"_blank\" rel=\"noopener\">new letter<\/a> told FDA Commissioner Dr. Robert Califf that the claim was wrong.<\/p>\n<\/blockquote><\/div>\n<p>&#8220;As you are\u2062 well aware, Congress has a right to information contained at U.S. federal agencies \u200das it conducts its <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/all-fbi-agents-must-blow-their-whistles-or-theyll-be-complicit-in-bureaus-politicization\/\" title=\"All FBI Agents Must Blow Their Whistles Or They\u2019ll Be Complicit In Bureau\u2019s Politicization\">constitutional oversight responsibilities<\/a>,&#8221; Mr. Johnson said.<\/p>\n<p>&#8220;It is outrageous that FDA would assert that pending litigation, and particularly FOIA litigation, would allow\u2063 your agency to obstruct my congressional\u2064 oversight,&#8221; he added. &#8220;Any pending litigation FDA may have\u2062 relating to its EB data mining records has no \u2063bearing on its responsibility\u200c to comply with a congressional request.&#8221;<\/p>\n<p>Mr. Johnson said in the past \u200dhe&#8217;s repeatedly received from the government documents subject\u2064 to litigation, \u200dincluding from\u200c the FDA&#8217;s parent agency, the U.S. Department of Health and Human Services (HHS).<\/p>\n<p>He urged the\u2063 FDA to produce the\u200d EB data mining analyses by Sept. 20.<\/p>\n<p>The FDA declined to immediately provide a \u200dcomment.<\/p>\n<div class=\"my-5\">\n<blockquote>\n<p>The agency <a href=\"https:\/\/www.theepochtimes.com\/us\/fda-sued-for-withholding-covid-19-vaccine-safety-analyses-5017378\" target=\"_blank\" rel=\"noopener\">was sued in\u2064 January<\/a> over its refusal to provide the results of the EB data mining \u200cto <a href=\"https:\/\/www.theepochtimes.com\/article\/exclusive-fda-refuses-to-provide-key-covid-19-vaccine-safety-analyses-4722586\" target=\"_blank\" rel=\"noopener\">The Epoch Times<\/a> and\u2062 the nonprofit Children&#8217;s Health Defense, citing exemptions in the Freedom of Information Act (FOIA).<\/p>\n<\/blockquote><\/div>\n<p>Children&#8217;s Health Defense, the litigant, said that the refusal to \u2064provide \u200bthe \u200brecords was illegal.<\/p>\n<div class=\"my-5\">\n<blockquote>\n<p>In <a href=\"https:\/\/www.documentcloud.org\/documents\/23940620-status-report-in-chd-fda-case\" target=\"_blank\" rel=\"noopener\">the last update<\/a> \u2064in the case, the FDA said it has 150 \u200bresponsive pages \u2063but that it \u200dhas to\u200d do a &#8220;page-by-page, line-by-line review&#8221; to determine whether any information on the\u2064 pages should be withheld, or redacted. The agency said it \u200dis \u200b&#8221;facing an unprecedented FOIA workload&#8221; stemming from federal courts ordering it to release information it\u200b had said would be made public on the COVID-19 vaccines from Pfizer and Moderna.<\/p>\n<\/blockquote><\/div>\n<div style=\"margin-left:0;margin-right:0;max-width:1200px\">\n<figure style=\"width:640px;margin-left:auto;margin-right:auto\" class=\"alignnone\"><figcaption>Sen.\u200d Ron Johnson (R-Wis.) speaks in Washington on May 15, 2023. (Madalina Vasiliu\/The Epoch Times)<\/figcaption><\/figure>\n<\/p><\/div>\n<div class=\"my-5\">\n<h2>Ignored Questions<\/h2>\n<p>In\u2062 another new letter, Mr. Johnson pressed the HHS \u2062on the program it administers to provide compensation to people injured by the COVID-19 shots.<\/p>\n<\/p><\/div>\n<p>Despite injections starting in December \u20642020, \u2064and more than 1.5 million reports being lodged with the Vaccine Adverse Event Reporting System. HHS has compensated just four people, paying $8,592\u2063 in total.<\/p>\n<p>Others have been approved for compensation but the money \u200cis still pending.<\/p>\n<p>Mr. Johnson in\u2063 April \u2064asked for more details on the program as the agency has not been \u2063forthcoming, including whether there are caps \u200bon the amount of money an injured person can receive and \u2064whether the government \u2063has advertised the program.<\/p>\n<p>Mr. Johnson also demanded communications between HHS and COVID-19 vaccine\u2064 manufacturers regarding\u2064 compensation claims.<\/p>\n<div class=\"my-5\">\n<blockquote>\n<p>In a recent letter, HHS <a href=\"https:\/\/www.documentcloud.org\/documents\/23940626-hhs-letter-to-sen-johnson\" target=\"_blank\" rel=\"noopener\">declined<\/a> to answer many of the questions.<\/p>\n<\/blockquote><\/div>\n<div class=\"my-5\">\n<blockquote>\n<p>Mr. Johnson on Sept. \u200c5 <a href=\"https:\/\/www.documentcloud.org\/documents\/23940633-sen-johnson-letter-to-hhs\" target=\"_blank\" rel=\"noopener\">urged<\/a> HHS Secretary Xavier Becerra \u2064to provide answers to all of his \u2062questions.<\/p>\n<\/blockquote><\/div>\n<p>He pointed to how Mr. Becerra, when being vetted by the Senate, told senators that he would commit to providing a prompt response to\u2063 any<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>U.S. officials deny a senator&#8217;s request for COVID-19 vaccine safety data. Sen. Ron Johnson sought FDA&#8217;s analysis results from the Vaccine Adverse Event Reporting System. This follows CDC&#8217;s statement of no adverse events.<\/p>\n","protected":false},"author":75,"featured_media":2024387,"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-2024386","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\/2024386","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\/75"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2024386"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2024386\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2024387"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2024386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2024386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2024386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}