{"id":9782,"date":"2021-06-24T19:45:59","date_gmt":"2021-06-24T09:45:59","guid":{"rendered":"https:\/\/mvec.mcri.edu.au\/?p=9782"},"modified":"2021-06-24T19:51:07","modified_gmt":"2021-06-24T09:51:07","slug":"tga-grants-provisional-determination-for-the-moderna-covid-19-vaccine-elasomeran","status":"publish","type":"post","link":"https:\/\/mvec.mcri.edu.au\/zh\/tga-grants-provisional-determination-for-the-moderna-covid-19-vaccine-elasomeran\/","title":{"rendered":"TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran"},"content":{"rendered":"<p>The Therapeutic Goods Administration (TGA) has granted provisional determination to Moderna Australia Pty Ltd for their COVID-19 vaccine candidate, Elasomeran. It is being considered for use in those aged 12 years or older for active immunisation to prevent COVID-19 disease. It is an mRNA vaccine requiring two doses, given 28 days apart.<\/p>\n<p>Granting provisional determination means that Moderna Australia Pty Ltd is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.<\/p>\n<p>Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.<\/p>\n<p>You can read the press release from the TGA below:<\/p>\n<p id=\"page-title\" class=\"page__title title\"><a href=\"https:\/\/www.tga.gov.au\/media-release\/tga-grants-provisional-determination-moderna-covid-19-vaccine-elasomeran\" target=\"_blank\" rel=\"noopener\">TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran<\/a><\/p>\n<p>For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:<\/p>\n<p><a href=\"https:\/\/mvec.mcri.edu.au\/references\/provisional-registration-of-covid-19-vaccines-in-australia\/\">MVEC: Provisional registration of COVID-19 vaccine(s) in Australia<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>The Moderna Australia Pty Ltd COVID-19 vaccine candidate, Elasomeran, has been granted provisional determination by the TGA. It is being considered for use in those aged 12 years or older for active immunisation to prevent COVID-19 disease. <\/p>","protected":false},"author":375,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_lmt_disableupdate":"","_lmt_disable":"","footnotes":"","_wp_rev_ctl_limit":""},"categories":[87,8,10],"tags":[],"class_list":["post-9782","post","type-post","status-publish","format-standard","hentry","category-news","category-covid-19","category-external"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran - The Melbourne Vaccine Education Centre (MVEC)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mvec.mcri.edu.au\/zh\/tga-grants-provisional-determination-for-the-moderna-covid-19-vaccine-elasomeran\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran - The Melbourne Vaccine Education Centre (MVEC)\" \/>\n<meta property=\"og:description\" content=\"The Moderna Australia Pty Ltd COVID-19 vaccine candidate, Elasomeran, has been granted provisional determination by the TGA. 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