{"id":72125,"date":"2020-12-08T17:42:32","date_gmt":"2020-12-08T12:12:32","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=72125"},"modified":"2021-05-08T16:00:44","modified_gmt":"2021-05-08T10:30:44","slug":"authorisation-of-coronavirus-vaccines","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/authorisation-of-coronavirus-vaccines\/","title":{"rendered":"Authorisation of coronavirus vaccines"},"content":{"rendered":"\n<p><strong>Context:<\/strong>\u00a0Safety and efficacy data for the new vaccine must be known before emergency-use authorisation for vaccines.<\/p>\n<h5><strong>Why in news?<\/strong><\/h5>\n<ul>\n<li>The Pune-based Serum Institute of India has approached the regulator for nod for its vaccine, Covishield, developed by Oxford University.<\/li>\n<li>AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies.<\/li>\n<li>AstraZeneca recently gave details of the\u00a0<strong>interim safety and efficacy data<\/strong>\u00a0involving 131 COVID-19 cases in the phase-3 trials in the U.K. and Brazil. But details of the trials in India are not out yet.<\/li>\n<\/ul>\n<h5><strong>Why fast tracking of vaccine authorization is needed?<\/strong><\/h5>\n<ul>\n<li>The unprecedented speed in taking the\u00a0<strong>vaccine from the development stage to approval process<\/strong>\u00a0in less than a year is remarkable but also necessitated by the toll the virus has taken on lives and livelihoods.<\/li>\n<li>To reduce mortality and morbidity.<\/li>\n<\/ul>\n<h5><strong>What are the concerns associated with authorization of vaccines?<\/strong><\/h5>\n<ul>\n<li><strong>Regulatory bodies under pressure<\/strong>: to\u00a0<strong>fast-track<\/strong>\u00a0the entire process.<\/li>\n<li><strong>Lack of transparency<\/strong>: Opaqueness about vaccine safety and efficacy does no good in gaining people\u2019s confidence and willingness to get vaccinated.\n<ul>\n<li>For example, Moderna, Pfizer and AstraZeneca took the extraordinary step of publicly sharing the trial protocol, the time points at which interim analysis of phase-3 trial in India will be carried out for safety and efficacy is unclear.<\/li>\n<\/ul>\n<\/li>\n<li><strong>No checks<\/strong>: the U.S. FDA has clearly spelt out at least 50% efficacy and stipulated a median follow-up duration of at least two months after completion of the full vaccination regimen to assess a vaccine\u2019s benefit-risk profile for emergency-use approval. However, no such conditions have been mentioned by the Indian regulatory agency. The phase-3 trial of Covishield began on September 21 and completed the enrolment on November 12.<\/li>\n<li><strong>Fear of side effects and vaccine hesitancy<\/strong>: ineffective or unsafe vaccine is worse than not having one.A survey by the London-based Vaccine Confidence Project revealed that though the intent to get vaccinated was 87% in India, 34% respondents were worried about side-effects while 16% were concerned about fast-moving trials.<\/li>\n<\/ul>\n<h5><strong>What needs to be done?<\/strong><\/h5>\n<ul>\n<li>Need to engage all stakeholders in a transparent manner at every stage and not by merely sharing guidelines regarding vaccine safety with the States.<\/li>\n<li>It is also important that those seeking emergency-use authorisation share the safety and efficacy data immediately.<\/li>\n<\/ul>\n<p>For further read about Emergency Use Authorisation : <a href=\"https:\/\/forumias.com\/blog\/process-and-issues-linked-to-emergency-use-authorisation-eua-of-covid-vaccines-in-india\/\">Click here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Context:\u00a0Safety and efficacy data for the new vaccine must be known before emergency-use authorisation for vaccines. Why in news? The Pune-based Serum Institute of India has approached the regulator for nod for its vaccine, Covishield, developed by Oxford University. AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/authorisation-of-coronavirus-vaccines\/\">Continue reading <span class=\"screen-reader-text\">Authorisation of coronavirus vaccines<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":72260,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1230,8043,1351,1310],"tags":[1315,1289,1456,1472],"class_list":["post-72125","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-9-pm-daily-articles","category-current-affairs-cat","category-daily-news","category-daily-news-updates","tag-st_1","tag-soc_0","tag-soc_01","tag-vaccine_related_issues","entry"],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/forumias.com\/blog\/wp-content\/uploads\/2020\/12\/Authorisation-of-coronavirus-vaccines.jpg?fit=1280%2C720&ssl=1","views":{"total":0,"cached_at":"","cached_date":1704898314},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/72125","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/comments?post=72125"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/72125\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media\/72260"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=72125"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=72125"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=72125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}