{"id":4428,"date":"2021-10-24T16:26:37","date_gmt":"2021-10-24T06:56:37","guid":{"rendered":"https:\/\/www.evidencebasedscience.net\/site\/?p=4428"},"modified":"2021-10-26T17:12:52","modified_gmt":"2021-10-26T07:42:52","slug":"no-covid-19-vaccine-has-received-full-tga-approval-in-australi","status":"publish","type":"post","link":"https:\/\/www.evidencebasedscience.net\/site\/2021\/10\/24\/no-covid-19-vaccine-has-received-full-tga-approval-in-australi\/","title":{"rendered":"No Covid-19 vaccine has received full TGA approval in Australia"},"content":{"rendered":"\n<p>Despite claims otherwise, the Covid-19 vaccines in fact have &#8220;provisional&#8221; approval only with the Therapeutic Goods Administration (TGA), and DO NOT have full approval as is implied by the Government and in the media. Despite the claims of a \u201cstringent process\u201d, provisional approvals are based on preliminary data.<\/p>\n\n\n\n<p>As of 24 October 2021, the following is a list of the Covid-19 vaccines with <span style=\"text-decoration: underline;\"><em>provisional<\/em><\/span> approval <span id=\"b805ba90-dec2-4c77-9649-0ccafe69e75a\" data-items=\"[&quot;2584796210&quot;]\" contenteditable=\"false\" class=\"abt-citation\">\u200b[1]\u200b<\/span>:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Moderna Spikevax (mRNA)<\/li><li>Janssen-Cilag Covid-19 Vaccine Janssen (viral vector)<\/li><li>AstraZeneca Vaxzevria (viral vector)<\/li><li>Pfizer Comirnaty &#8211; BNT162b2 (mRNA)<span id=\"57445f07-c364-4803-940b-82ac2e81a6cc\" data-items=\"[&quot;2584796210&quot;]\" contenteditable=\"false\" class=\"abt-citation\">\u200b[1]\u200b<\/span><\/li><\/ul>\n\n\n\n<p>The TGA provides an explanation of the provisional approval process:<\/p>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<p><strong>Provisional registration process<\/strong><br>As part of the provisional approval pathway, the provisional registration process will allow certain medicines to be provisionally registered in the Australian Register of Therapeutic Goods (ARTG) for a limited duration. <em><strong>These medicines are registered on the basis of preliminary clinical dat<\/strong><\/em>a, where the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required. <span id=\"592e48bc-fc57-4fe5-b900-b93b331a12d4\" data-items=\"[&quot;2842370195&quot;]\" contenteditable=\"false\" class=\"abt-citation\">\u200b[2]\u200b<\/span> (emphasis added)<\/p>\n<\/div><\/div>\n\n\n\n<p>Clearly, the provisional approval process is <span style=\"text-decoration: underline;\">not the same<\/span> process as undertaken by other vaccines.  While Australia does not have an Emergency Use Listing (EUL) as per other countries globally, this terminology is merely semantics. To be clear, the TGA has no other \u201cemergency\u201d process, and fast tracking of approvals occurs via the provisional pathway.<\/p>\n\n\n\n<p>Any suggestion that the Covid-19 vaccines have gone through the same process as other medications is a deliberate and horrific deception.<\/p>\n\n\n\n<section aria-label=\"Bibliography\" class=\"wp-block-abt-bibliography abt-bibliography\" role=\"region\"><ol class=\"abt-bibliography__body\" data-maxoffset=\"3\" data-linespacing=\"1\" data-second-field-align=\"flush\"><li id=\"2584796210\">  <div class=\"csl-entry\">\n    <div class=\"csl-left-margin\">1. <\/div><div class=\"csl-right-inline\">Therapeutic Goods Administration (TGA): COVID-19 vaccine: Provisional registrations, <a href=\"https:\/\/www.tga.gov.au\/covid-19-vaccine-provisional-registrations\">https:\/\/www.tga.gov.au\/covid-19-vaccine-provisional-registrations<\/a><\/div>\n  <\/div>\n<\/li><li id=\"2842370195\">  <div class=\"csl-entry\">\n    <div class=\"csl-left-margin\">2. <\/div><div class=\"csl-right-inline\">Therapeutic Goods Administration (TGA): Provisional registration process, <a href=\"https:\/\/www.tga.gov.au\/publication\/provisional-registration-process\">https:\/\/www.tga.gov.au\/publication\/provisional-registration-process<\/a><\/div>\n  <\/div>\n<\/li><\/ol><\/section>\n","protected":false},"excerpt":{"rendered":"<p>Despite claims otherwise, the Covid-19 vaccines in fact have &#8220;provisional&#8221; approval only with the Therapeutic Goods Administration (TGA), and DO NOT have full approval as is implied by the Government and in the media. Despite the claims of a \u201cstringent process\u201d, provisional approvals are based on preliminary data. As of 24 October 2021, the following &#8230; <a title=\"No Covid-19 vaccine has received full TGA approval in Australia\" class=\"read-more\" href=\"https:\/\/www.evidencebasedscience.net\/site\/2021\/10\/24\/no-covid-19-vaccine-has-received-full-tga-approval-in-australi\/\" aria-label=\"Read more about No Covid-19 vaccine has received full TGA approval in Australia\">Read more<\/a><\/p>\n","protected":false},"author":2,"featured_media":4434,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"give_campaign_id":0,"footnotes":""},"categories":[1,7],"tags":[],"class_list":["post-4428","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all","category-covid-19-vaccines","masonry-post","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-33"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>No Covid-19 vaccine has received full TGA approval in Australia - Evidence Based Science<\/title>\n<meta name=\"description\" content=\"Despite claims otherwise, the Covid-19 vaccines in fact have &quot;provisional&quot; approval only with the Therapeutic Goods Administration (TGA), and DO NOT have full approval as is implied by the Government and in the media. 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