{"id":75348,"date":"2021-01-04T18:22:45","date_gmt":"2021-01-04T12:52:45","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=75348"},"modified":"2021-01-08T16:23:36","modified_gmt":"2021-01-08T10:53:36","slug":"concerns-of-hasty-approval-to-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/concerns-of-hasty-approval-to-covid-19-vaccine\/","title":{"rendered":"Concerns of hasty approval to COVID-19 vaccine"},"content":{"rendered":"<p><span data-contrast=\"none\"><strong>Synopsis-<\/strong><\/span><span data-contrast=\"none\">\u00a0Concerns regarding hasty approval granted to the COVID-19 vaccines despites the lack of adequate efficacy data.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\"><strong>Background-<\/strong><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"none\">The Drug Controller General of India (DCGI)\u202fapproved the Subject Expert Committee\u2019s recommendation for emergency use\u202fof Serum Institute of India\u2019s\u00a0Covishieldand Bharat Biotech\u2019s<\/span><span data-contrast=\"none\">\u202f<\/span><span data-contrast=\"none\"><strong>Covaxin<\/strong><\/span><span data-contrast=\"none\">.\u202f<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">Covishieldis the same vaccine as developed by Oxford- AstraZeneca, which has got emergency use approval in the UK.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">In the case of\u00a0Covaxin, concerns have been raised about the\u00a0absence of efficacy data, which is generated during Phase 3 of human clinical trials.<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">However, experts have voiced their concerns on the approval process and the lack of publicly released efficacy data for\u00a0Covaxin.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\"><strong>How India\u2019s credibility as manufacturer of vaccine is at stake?<\/strong><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The hasty nod for\u00a0Covaxin\u00a0has put India\u2019s credibility as a manufacturer of vaccines is at a stake and has raised eyebrows in the scientific and healthcare communities about a \u201cpublic rollout of an untested product.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"none\"><strong>First,\u00a0Covaxinhas no clinical efficacy data-<\/strong><\/span><span data-contrast=\"none\">\u00a0Bharat\u00a0Biotch\u2019s\u00a0Covaxin\u00a0vaccine is still in stage 3 clinical trials in India and the final results are yet to be released. The recommendation comes despite the lack of efficacy data for\u00a0Covaxin.\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span>\n<ul>\n<li><span data-contrast=\"none\">Efficacy data is an indication of how effective the vaccine is in preventing the virus attack.<\/span><\/li>\n<li><span data-contrast=\"none\">Moreover, the decision is a violation of the criteria in the draft regulatory guidelines for the development of COVID-19 vaccines published by CDSCO, in which it is clear that safety and efficacy data is required for approval of vaccine, but the indigenous vaccine from\u202fBharat Biotech\u202fdoes not have efficacy details because the trials are underway.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span data-contrast=\"none\"><strong>Second, credibility of regulator at stake-<\/strong><\/span><span data-contrast=\"none\">This lack of transparency could lead to a lack of trust in the vaccine<\/span><span data-contrast=\"none\">.<\/span><span data-contrast=\"none\">\u00a0<\/span><span data-contrast=\"none\">There are several issues with the way the approval has been granted, which can lead to people losing confidence in the regulatory system.<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\"><strong>Third,\u00a0<\/strong><\/span><span data-contrast=\"none\">approval an untested vaccine makes it nearly\u00a0impossible to conduct a proper phase-3 trial.<\/span>\n<ul>\n<li><span data-contrast=\"none\">It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere.<\/span><\/li>\n<\/ul>\n<\/li>\n<li><span data-contrast=\"none\"><strong>Fourth,\u00a0<\/strong><\/span><span data-contrast=\"none\">Pharmaceutical giants like Pfizer, Moderna and AstraZeneca have given a go-ahead only after partial results of\u00a0vaccine\u2019s abilities in their own populations.<\/span><\/li>\n<li><span data-contrast=\"none\">Whereas in India similar data for\u00a0vaccine ability among Indian population has not been published. As it is a possibility that vaccine response among India population may not be the same as among the European Population.\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">The rush to approve COVID-19 vaccine without proper clinical trial may do more harm than good. So, it would be better to wait for the preliminary data from the phase-III trials to come in, and then grant the approval.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\"><strong>What is the way forward?<\/strong><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li><span data-contrast=\"none\">In light of the intense concerns arising from the absence of efficacy data, the Use of\u00a0Covaxinshould be treated as extended clinical trials.\u202f<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/li>\n<li><span data-contrast=\"none\">For the larger scale implementation of vaccines, Government needs to carefully monitor immune response to different vaccines and assess the efficacy across populations.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Synopsis-\u00a0Concerns regarding hasty approval granted to the COVID-19 vaccines despites the lack of adequate efficacy data.\u00a0\u00a0 Background-\u00a0 The Drug Controller General of India (DCGI)\u202fapproved the Subject Expert Committee\u2019s recommendation for emergency use\u202fof Serum Institute of India\u2019s\u00a0Covishieldand Bharat Biotech\u2019s\u202fCovaxin.\u202f\u00a0 Covishieldis the same vaccine as developed by Oxford- AstraZeneca, which has got emergency use approval in the&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/concerns-of-hasty-approval-to-covid-19-vaccine\/\">Continue reading <span class=\"screen-reader-text\">Concerns of hasty approval to COVID-19 vaccine<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":75355,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1230,1351,1310,9],"tags":[1289,1456,1472],"class_list":["post-75348","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-9-pm-daily-articles","category-daily-news","category-daily-news-updates","category-public","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\/2021\/01\/Concerns-of-hasty-approval-to-COVID-19-vaccine.jpg?fit=1280%2C720&ssl=1","views":{"total":0,"cached_at":"","cached_date":1703156570},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/75348","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=75348"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/75348\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media\/75355"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=75348"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=75348"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=75348"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}