{"id":83559,"date":"2021-09-09T15:16:24","date_gmt":"2021-09-09T19:16:24","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=83559"},"modified":"2021-09-09T15:17:47","modified_gmt":"2021-09-09T19:17:47","slug":"fda-sued-over-approval-of-pfizer-comirnaty-vaccine","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=83559","title":{"rendered":"FDA Sued Over Approval of Pfizer Comirnaty Vaccine"},"content":{"rendered":"<h1>Children\u2019s Health Defense Sues FDA Over Approval of Pfizer Comirnaty Vaccine<\/h1>\n<h3><em>The lawsuit, filed Aug. 31, alleges the U.S. Food and Drug Administration violated<\/em><br \/>\n<em>federal law when the agency simultaneously licensed Pfizer\u2019s Comirnaty COVID vaccine and extended Emergency Use Authorization for the Pfizer-BioNTech vaccine.<\/em><\/h3>\n<p><!--more-->By Children&#8217;s Health Defense Team<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-83560\" src=\"http:\/\/stateofthenation.co\/wp-content\/uploads\/2021\/09\/CHD-FDA-Comirnaty-lawsuit-feature-800x417-1.jpg\" alt=\"\" width=\"800\" height=\"417\" srcset=\"http:\/\/stateofthenation.co\/wp-content\/uploads\/2021\/09\/CHD-FDA-Comirnaty-lawsuit-feature-800x417-1.jpg 800w, http:\/\/stateofthenation.co\/wp-content\/uploads\/2021\/09\/CHD-FDA-Comirnaty-lawsuit-feature-800x417-1-300x156.jpg 300w, http:\/\/stateofthenation.co\/wp-content\/uploads\/2021\/09\/CHD-FDA-Comirnaty-lawsuit-feature-800x417-1-768x400.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/p>\n<p><a href=\"https:\/\/childrenshealthdefense.org\/\">Children\u2019s Health Defense<\/a> (CHD) on Aug. 31 <a href=\"https:\/\/childrenshealthdefense.org\/wp-content\/uploads\/CHD-v.-FDA-Submitted-Complaint-8.31.21.pdf\">filed suit<\/a> in U.S. District Court, Eastern District of Tennessee against the U.S. Food and Drug Administration (FDA) and its acting director, <a href=\"https:\/\/childrenshealthdefense.org\/defender\/janet-woodcock-wrong-person-lead-fda\/\">Dr. Janet Woodcock<\/a>, for their allegedly deceptive, <a href=\"https:\/\/childrenshealthdefense.org\/defender\/mainstream-media-fda-approval-pfizer-vaccine\/\">rushed licensure<\/a> of Pfizer\u2019s Comirnaty vaccine.<\/p>\n<p>CHD argues that the licensure was a classic \u201cbait and switch,\u201d allowing <a href=\"https:\/\/childrenshealthdefense.org\/defender\/fully-vaccinated-pfizer-more-likely-get-delta-than-natural-immunity\/\">Pfizer<\/a>, the Biden administration, the <a href=\"https:\/\/childrenshealthdefense.org\/defender\/military-service-members-natural-immunity-lawsuit-dod-fda-hhs-covid-vaccine-mandate\/\">U.S. military<\/a> and employers to exhort people to take \u201clicensed\u201d vaccines when in fact the vaccines available and being administered continued to be the Pfizer-BioNTech <a href=\"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization\">Emergency Use Authorization<\/a> (EUA) vaccines.<\/p>\n<div class=\"twitter-tweet twitter-tweet-rendered\"><iframe id=\"twitter-widget-0\" class=\"\" title=\"Twitter Tweet\" src=\"https:\/\/platform.twitter.com\/embed\/Tweet.html?dnt=false&amp;embedId=twitter-widget-0&amp;features=eyJ0ZndfZXhwZXJpbWVudHNfY29va2llX2V4cGlyYXRpb24iOnsiYnVja2V0IjoxMjA5NjAwLCJ2ZXJzaW9uIjpudWxsfSwidGZ3X2hvcml6b25fdHdlZXRfZW1iZWRfOTU1NSI6eyJidWNrZXQiOiJodGUiLCJ2ZXJzaW9uIjpudWxsfSwidGZ3X3NwYWNlX2NhcmQiOnsiYnVja2V0Ijoib2ZmIiwidmVyc2lvbiI6bnVsbH0sInRmd192ZGxfY2hpcnBfMTI3OTQiOnsiYnVja2V0IjoidmRsX29ubHkiLCJ2ZXJzaW9uIjozfX0%3D&amp;frame=false&amp;hideCard=false&amp;hideThread=false&amp;id=1430525824176902150&amp;lang=en&amp;origin=https%3A%2F%2Fchildrenshealthdefense.org%2Fdefender%2Fchildrens-health-defense-sues-fda-pfizer-comirnaty-covid-vaccine%2F&amp;sessionId=d6d7e23fd0b10476caa5936f2c687b0878678556&amp;siteScreenName=ChildrensHD&amp;theme=light&amp;widgetsVersion=1890d59c%3A1627936082797&amp;width=550px\" frameborder=\"0\" scrolling=\"no\" allowfullscreen=\"allowfullscreen\" data-tweet-id=\"1430525824176902150\" data-mce-fragment=\"1\"><\/iframe><\/div>\n<p>&nbsp;<\/p>\n<p>According to the lawsuit, the FDA violated federal law when it simultaneously licensed Pfizer\u2019s \u201cComirnaty\u201d vaccine and extended Pfizer\u2019s EUA for its vaccine that has the \u201csame formulation\u201d and that \u201ccan be used interchangeably,\u201d <a href=\"https:\/\/childrenshealthdefense.org\/defender\/no-one-can-force-you-pfizers-comirnaty-vaccine\/\">according to the FDA<\/a>.<\/p>\n<p>The law (<a href=\"https:\/\/www.law.cornell.edu\/uscode\/text\/21\/360bbb-3\" target=\"_blank\" rel=\"noopener\">21 U.S. Code \u00a7 360bbb-3-(3)<\/a>) on \u201cauthorization for medical products for use in emergencies\u201d requires the EUA designation be used only when \u201cthere is no adequate, approved and available alternative to the product for diagnosing, preventing or treating such disease or condition.\u201d<\/p>\n<p>The lawsuit alleges once the FDA approved and licensed Pfizer\u2019s Comirnaty vaccine, there was no further basis for the FDA to preserve the EUA status for the Pfizer-BioNTech vaccine that <a href=\"https:\/\/www.fda.gov\/media\/150386\/download\" target=\"_blank\" rel=\"noopener\">Pfizer acknowledges<\/a> has the \u201csame formulation\u201d and is \u201cinterchangeable.\u201d<\/p>\n<div class=\"covid-on-trial-banner\"><span class=\"cotb-container\"><a href=\"https:\/\/www.amazon.com\/Real-Anthony-Fauci-Democracy-Childrens\/dp\/1510766804\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"neon-green\">ORDER TODAY:<\/span> Robert F. Kennedy, Jr.&#8217;s New Book \u2014 &#8216;The Real Anthony Fauci&#8217;<\/a><\/span><\/div>\n<p>There also is no basis to retain EUA status for other <a href=\"https:\/\/childrenshealthdefense.org\/defender_category\/covid\/\">COVID<\/a> vaccines for the same use and for the same population as Pfizer\u2019s Comirnaty vaccine, according to the complaint.<\/p>\n<p>\u201cThe FDA must justify its actions in open court,\u201d said Mary Holland, CHD president and general counsel. \u201cThe language of its licensure is nearly incomprehensible, and the result of licensed and unlicensed vaccines for the same indication is arbitrary.\u201d<\/p>\n<p>CHD is asking the court to vacate and remand the FDA\u2019s decisions to license Pfizer\u2019s Comirnaty vaccine and to extend EUA for the Pfizer-BioNTech vaccine.<\/p>\n<p>Attorneys\u00a0Robert F. Barnes and Derek Jordan of Barnes Law are the lead attorneys along with CHD Chairman and Chief Legal Counsel Robert F. Kennedy, Jr. and other counsel for CHD.<\/p>\n<p>On May 16, CHD submitted a <a href=\"https:\/\/childrenshealthdefense.org\/wp-content\/uploads\/FDA-2021-P-0460-0001_attachment_1.pdf\">Citizen Petition<\/a> to the FDA calling on the agency, to among other things, revoke all COVID vaccine EUAs and refrain from approving any future EUA, new drug applications or biologics license applications for any COVID vaccine for all demographic groups because the risks of serious adverse events or deaths outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the EUAs. The petition garnered more than <a href=\"https:\/\/www.regulations.gov\/commenton\/FDA-2021-P-0460-0001\" target=\"_blank\" rel=\"noopener\">30,000 public comments<\/a>.<\/p>\n<p>On Aug. 23, the same day the FDA licensed the Pfizer Comirnaty vaccine,\u00a0the agency responded\u00a0to CHD\u2019s petition. This licensure and <a href=\"https:\/\/childrenshealthdefense.org\/wp-content\/uploads\/FDA-Response-FDA-2021-P-0460.pdf\">FDA response<\/a> cleared the administrative path for CHD to file suit.<\/p>\n<p>___<br \/>\n<a href=\"https:\/\/childrenshealthdefense.org\/defender\/childrens-health-defense-sues-fda-pfizer-comirnaty-covid-vaccine\/?utm_source=salsa&amp;eType=EmailBlastContent&amp;eId=0ae87ec1-ff3b-4324-aec9-20f818857cb8\">https:\/\/childrenshealthdefense.org\/defender\/childrens-health-defense-sues-fda-pfizer-comirnaty-covid-vaccine\/?utm_source=salsa&amp;eType=EmailBlastContent&amp;eId=0ae87ec1-ff3b-4324-aec9-20f818857cb8<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Children\u2019s Health Defense Sues FDA Over Approval of Pfizer Comirnaty Vaccine The lawsuit, filed Aug. 31, alleges the U.S. Food and Drug Administration violated federal law when the agency simultaneously licensed Pfizer\u2019s Comirnaty COVID vaccine and extended Emergency Use Authorization &hellip; <a href=\"http:\/\/stateofthenation.co\/?p=83559\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-83559","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/83559","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=83559"}],"version-history":[{"count":0,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/83559\/revisions"}],"wp:attachment":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=83559"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=83559"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=83559"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}