{"id":84689,"date":"2021-09-18T13:28:54","date_gmt":"2021-09-18T17:28:54","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=84689"},"modified":"2021-09-18T13:29:08","modified_gmt":"2021-09-18T17:29:08","slug":"fda-panel-overwhelmingly-rejects-pfizer-booster","status":"publish","type":"post","link":"https:\/\/stateofthenation.co\/?p=84689","title":{"rendered":"<b>FDA Panel Overwhelmingly Rejects Pfizer Booster<\/b>"},"content":{"rendered":"<h1>BREAKING: FDA Panel Overwhelmingly Rejects Pfizer Booster for Healthy People 16 and Older<\/h1>\n<h3><em>The 16 &#8211; 2 vote came after a sharp debate in which many of the panel\u2019s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe COVID-19 disease and hospitalization.<\/em><\/h3>\n<p><!--more-->By Children&#8217;s Health Defense Team<\/p>\n<p>Following an <a href=\"https:\/\/www.nytimes.com\/live\/2021\/09\/17\/world\/covid-delta-variant-vaccine\" target=\"_blank\" rel=\"noopener\">intense daylong public discussion<\/a>, a panel of scientific advisors to the U.S. Food and Drug Administration (FDA) today voted 16 to 2 against recommending a third shot of Pfizer\u2019s <a href=\"https:\/\/childrenshealthdefense.org\/defender_category\/covid\/\">COVID vaccine<\/a> for people 16 and older.<\/p>\n<p>The vote came after a sharp debate in which many of the panel\u2019s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe COVID-19 disease and hospitalization, at least in the U.S., <a href=\"https:\/\/www.nytimes.com\/live\/2021\/09\/17\/world\/covid-delta-variant-vaccine\" target=\"_blank\" rel=\"noopener\">the New York Times reported<\/a>.<\/p>\n<div class=\"epyt-video-wrapper fluid-width-video-wrapper\"><iframe id=\"_ytid_93988\" class=\"__youtube_prefs__ no-lazyload\" title=\"YouTube player\" src=\"https:\/\/www.youtube.com\/embed\/WFph7-6t34M?enablejsapi=1&amp;autoplay=0&amp;cc_load_policy=0&amp;cc_lang_pref=&amp;iv_load_policy=1&amp;loop=0&amp;modestbranding=0&amp;rel=1&amp;fs=1&amp;playsinline=0&amp;autohide=2&amp;theme=dark&amp;color=red&amp;controls=1&amp;&amp;origin=https:%2F%2Fchildrenshealthdefense.org\" allowfullscreen=\"allowfullscreen\" data-origwidth=\"1200\" data-origheight=\"675\" data-no-lazy=\"1\" data-skipgform_ajax_framebjll=\"\"><\/iframe><\/div>\n<p>\u201cIt\u2019s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,\u201d said Dr. Michael G. Kurilla, a committee member and official at the National Institutes of Health.<\/p>\n<p>The issue of whether or not to approve boosters has become increasingly contentious, dividing scientists, both outside and inside the FDA, including <a href=\"https:\/\/childrenshealthdefense.org\/defender\/fda-officials-science-doesnt-support-third-shot\/\">two scientists<\/a> who recently announced they are leaving the agency because of pressure from the Biden administration to approve boosters, despite the lack of data to support a third shot.<\/p>\n<p>The Biden administration had hoped the FDA would approve a third shot of the <a href=\"https:\/\/childrenshealthdefense.org\/defender\/childrens-health-defense-sues-fda-pfizer-comirnaty-covid-vaccine\/\">Pfizer<\/a> vaccine in time to begin rolling out boosters for Pfizer recipients next week.<\/p>\n<p>\u201cIt\u2019s a welcome sight to see actual deliberations in meetings about vaccine booster shots at the FDA,\u201d said Mary Holland, president of <a href=\"https:\/\/childrenshealthdefense.org\/\">Children\u2019s Health Defense<\/a>. \u201cIt\u2019s encouraging that a panel of experts stood up to political and corporate pressure based on the lack of convincing data for safety and efficacy of boosters.\u201d<\/p>\n<p>Holland added:<\/p>\n<p>\u201cOne can only hope the FDA and Centers for Disease Control and Prevention panels will continue to engage in vigorous debate about vaccine science and medicine.\u201d<\/p>\n<p>As <a href=\"https:\/\/thehill.com\/policy\/healthcare\/572793-fda-panel-votes-against-covid-19-booster-recommendation\" target=\"_blank\" rel=\"noopener\">The Hill reported<\/a>, the advisory panel\u2019s vote is not binding, so the FDA doesn\u2019t have to accept the results. But if the agency doesn\u2019t, it will raise significant questions of political interference and pit agency scientists against political officials who signed off on the booster plan.<\/p>\n<p>In an unusual move last month, Biden and top health officials, including Surgeon General Vicek Murthy, acting FDA Commissioner Dr. Janet Woodcock and CDC\u00a0 Director <a href=\"https:\/\/thehill.com\/people\/rochelle-walensky\" target=\"_blank\" rel=\"noopener\">Dr, Rochelle Walensky<\/a>, publicly announced a booster shot program would begin the week of Sept. 20, well before the FDA and CDC examined the evidence.<\/p>\n<p>On Thursday, FDA scientists had <a href=\"https:\/\/childrenshealthdefense.org\/defender\/fda-scientists-pfizer-covid-boosters-lack-data\/\">expressed skepticism<\/a> about the need for Pfizer <a href=\"https:\/\/childrenshealthdefense.org\/defender_category\/covid\/\">COVID<\/a> vaccine booster shots in a <a href=\"https:\/\/www.wsj.com\/articles\/fda-says-covid-19-vaccines-remain-effective-without-boosters-11631726504\" target=\"_blank\" rel=\"noopener\">report<\/a> released Wednesday.<\/p>\n<p>In the 23-page report, FDA officials said that based on their analysis of data submitted by Pfizer and BioNTech, they could not yet take a stance on whether to recommend COVID boosters for the general public.<\/p>\n<p>The 23-page report analyzed data submitted by Pfizer and BioNTech as part of the drugmakers\u2019 request for authorization for their vaccine to be given as a booster shot in people 16 years and older.<\/p>\n<p>___<br \/>\n<a href=\"https:\/\/childrenshealthdefense.org\/defender\/fda-panel-rejects-pfizer-booster-16-older\/?utm_source=salsa&amp;eType=EmailBlastContent&amp;eId=46208037-809c-4de9-b120-ede140be6c35\">https:\/\/childrenshealthdefense.org\/defender\/fda-panel-rejects-pfizer-booster-16-older\/?utm_source=salsa&amp;eType=EmailBlastContent&amp;eId=46208037-809c-4de9-b120-ede140be6c35<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>BREAKING: FDA Panel Overwhelmingly Rejects Pfizer Booster for Healthy People 16 and Older The 16 &#8211; 2 vote came after a sharp debate in which many of the panel\u2019s independent experts, including infectious disease doctors and statisticians, challenged whether the &hellip; <a href=\"https:\/\/stateofthenation.co\/?p=84689\">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-84689","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/84689","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=84689"}],"version-history":[{"count":0,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/84689\/revisions"}],"wp:attachment":[{"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=84689"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=84689"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=84689"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}