{"id":10327,"date":"2021-07-22T03:52:11","date_gmt":"2021-07-22T03:52:11","guid":{"rendered":"https:\/\/i3tk.org\/demo2\/?p=10327"},"modified":"2021-07-22T03:52:14","modified_gmt":"2021-07-22T03:52:14","slug":"eu-begins-real-time-review-of-sanofi-gsk-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/i3tk.org\/demo2\/world-news\/resources\/eu-begins-real-time-review-of-sanofi-gsk-covid-19-vaccine\/","title":{"rendered":"EU begins real-time review of Sanofi-GSK Covid-19 vaccine"},"content":{"rendered":"\n<p><a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/europe\">Europe<\/a>&#8216;s drug regulator said on Tuesday it had started a real-time review of the Covid-19 vaccine developed by French drugmaker&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/sanofi\">Sanofi<\/a>&nbsp;and Britain&#8217;s GlaxoSmithKline, the fifth shot currently under such a review.<\/p>\n\n\n\n<p>The decision to start the &#8220;rolling review&#8221; of the vaccine,&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/vidprevtyn\">Vidprevtyn<\/a>, was based on preliminary results from lab studies and early-stage clinical trials in adults, the&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/european+medicines+agency\">European Medicines Agency<\/a>&nbsp;(EMA).<\/p>\n\n\n\n<p>Late-stage global trials for the protein-based coronavirus vaccine candidate began in May.<\/p>\n\n\n\n<p>Sanofi and GSK hope to get approvals by the end of 2021 after early-stage results showed the vaccine produces a robust immune response.<\/p>\n\n\n\n<p>&#8220;EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality,&#8221; the regulator said, without giving details on data it had received so far and an expected timeline for approval.<\/p>\n\n\n\n<p>EMA&#8217;s rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.<\/p>\n\n\n\n<p>Sanofi said other rolling reviews of its vaccine were also about to start in Britain, Canada and&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/singapore\">Singapore<\/a>, as well as with the&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/world+health+organization\">World Health Organization<\/a>.<\/p>\n\n\n\n<p>Vidprevtyn uses the same technology as one of Sanofi&#8217;s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.<\/p>\n\n\n\n<p>Other Covid-19 vaccine candidates in the EU&#8217;s rolling review are those from&nbsp;<a href=\"https:\/\/health.economictimes.indiatimes.com\/tag\/curevac%2c+novavax\">CureVac, Novavax<\/a>, Sinovac and Russia&#8217;s Sputnik V.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The decision to start the &#8220;rolling review&#8221; of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early-stage clinical trials in adults, the European Medicines Agency (EMA).<\/p>\n","protected":false},"author":1,"featured_media":10328,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[87,85],"tags":[],"class_list":["post-10327","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-resources","category-world-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v18.8 (Yoast SEO v27.5) - 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