{"id":76794,"date":"2021-01-14T16:51:55","date_gmt":"2021-01-14T11:21:55","guid":{"rendered":"https:\/\/blog.forumias.com\/?p=76794"},"modified":"2021-01-14T19:04:49","modified_gmt":"2021-01-14T13:34:49","slug":"issues-in-the-process-of-covid-vaccine-trial","status":"publish","type":"post","link":"https:\/\/forumias.com\/blog\/issues-in-the-process-of-covid-vaccine-trial\/","title":{"rendered":"Issues in\u00a0the process of\u00a0COVID Vaccine trial\u00a0"},"content":{"rendered":"<p><b><span data-contrast=\"auto\">Synopsis:<\/span><\/b><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Many issues have been highlighted in the<\/span><span data-contrast=\"auto\">\u00a0Phase-3 trial of\u00a0<\/span><b><span data-contrast=\"auto\">Bharat Biotech\u2019s COVID-19 vaccine<\/span><\/b><b><span data-contrast=\"auto\">s<\/span><\/b><b><span data-contrast=\"auto\">. Those<\/span><\/b><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><b><span data-contrast=\"auto\">issues<\/span><\/b><b><span data-contrast=\"auto\">\u00a0could have been avoided after HPV vaccine trial controversy<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Introduction<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">In a previous case,\u00a0<\/span><\/b><b><span data-contrast=\"auto\">H<\/span><\/b><b><span data-contrast=\"auto\">uman papilloma virus (HPV) vaccine\u00a0<\/span><\/b><b><span data-contrast=\"auto\">trial<\/span><\/b><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">was carried out on nearly 23,500 girls in the 10-14 age\u00a0<\/span><span data-contrast=\"auto\">group<\/span><span data-contrast=\"auto\">\u00a0in Vadodara, Gujarat and\u00a0<\/span><span data-contrast=\"auto\">Khammam<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">without proper consent. Almost eight years later<\/span><span data-contrast=\"auto\">\u00a0the\u00a0<\/span><b><span data-contrast=\"auto\">Supreme Court of India\u00a0<\/span><\/b><b><span data-contrast=\"auto\">criticized<\/span><\/b><b><span data-contrast=\"auto\">\u00a0the government<\/span><\/b><span data-contrast=\"auto\">\u00a0for\u00a0<\/span><span data-contrast=\"auto\">its inability to take action on\u00a0<\/span><span data-contrast=\"auto\">illegal clinical trials carried out in India by multinational countries<\/span><span data-contrast=\"auto\">.<\/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=\"auto\">Present situation of the approv<\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">l process in India suggests<\/span><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><b><span data-contrast=\"auto\">n<\/span><\/b><b><span data-contrast=\"auto\">ot<\/span><\/b><b><span data-contrast=\"auto\">hing<\/span><\/b><b><span data-contrast=\"auto\">\u00a0much has\u00a0<\/span><\/b><b><span data-contrast=\"auto\">changed<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">The\u00a0<\/span><b><span data-contrast=\"auto\">phase-3 clinical trial of Bharat Biotech\u2019s COVID-19 vaccine<\/span><\/b><b><span data-contrast=\"auto\">\u00a0<\/span><\/b><span data-contrast=\"auto\">resembles the HPV vaccine<\/span><span data-contrast=\"auto\">\u00a0because it seems that the trial is suffering from serious violations.<\/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 data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">The I<\/span><b><span data-contrast=\"auto\">CMR which has <\/span><\/b><b><span data-contrast=\"auto\">assigned the\u00a0<\/span><\/b><b><span data-contrast=\"auto\">task of\u00a0<\/span><\/b><b><span data-contrast=\"auto\">promulgating\u00a0<\/span><\/b><b><span data-contrast=\"auto\">research ethics\u00a0<\/span><\/b><b><span data-contrast=\"auto\">guidelines<\/span><\/b><span data-contrast=\"auto\">\u00a0is\u00a0<\/span><span data-contrast=\"auto\">also\u00a0<\/span><span data-contrast=\"auto\">the cosponsor of the\u00a0<\/span><span data-contrast=\"auto\">Covaxin<\/span><span data-contrast=\"auto\">\u00a0trial.<\/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<\/ul>\n<p><b><span data-contrast=\"auto\">What are the problems\u00a0<\/span><\/b><b><span data-contrast=\"auto\">in the\u00a0<\/span><\/b><b><span data-contrast=\"auto\">C<\/span><\/b><b><span data-contrast=\"auto\">ovaxin<\/span><\/b><b><span data-contrast=\"auto\">\u00a0phase 3\u00a0<\/span><\/b><b><span data-contrast=\"auto\">trial<\/span><\/b><b><span data-contrast=\"auto\">?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">After the 2013 SC order, The Indian regulator made audio-video recording of the informed consent of each individual participant mandatory in 2019.<\/span><\/b><span data-contrast=\"auto\"> Written consent from the participant had to certainly be taken before the audio-video recording.<\/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=\"auto\">However, the process was not followed properly;<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Firstly<\/span><\/b><span data-contrast=\"auto\">, no efforts were made to explain and inform the participants about the pros and cons of taking part in the trial\u00a0<\/span><span data-contrast=\"auto\">i<\/span><span data-contrast=\"auto\">nstead;<\/span><span data-contrast=\"auto\">\u00a0they were\u00a0<\/span><span data-contrast=\"auto\">deceived<\/span><span data-contrast=\"auto\">\u00a0by the trial site to think they were getting a COVID-19 vaccine for free.<\/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 data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Secondly<\/span><\/b><span data-contrast=\"auto\">,<\/span><span data-contrast=\"auto\">\u00a0many<\/span><span data-contrast=\"auto\">\u00a0participants\u00a0<\/span><span data-contrast=\"auto\">didn\u2019t know about\u00a0<\/span><span data-contrast=\"auto\">their rights to<\/span><span data-contrast=\"auto\">\u00a0get<\/span><span data-contrast=\"auto\">\u00a0free medical care in case of any adverse events.<\/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<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Many aware participants sought medical help from private practitioners whereas some of the participants don\u2019t<\/span><span data-contrast=\"auto\">\u00a0possess mobile phones, thus medical follow-<\/span><span data-contrast=\"auto\">u<\/span><span data-contrast=\"auto\">p was not possible.\u00a0<\/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<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Thirdly,\u00a0<\/span><\/b><span data-contrast=\"auto\">not enough time was given\u00a0<\/span><span data-contrast=\"auto\">to discuss with the family\u00a0<\/span><span data-contrast=\"auto\">before signing the consent form<\/span><span data-contrast=\"auto\">.\u00a0<\/span><span data-contrast=\"auto\">A<\/span><span data-contrast=\"auto\">t least in a few instances, the consent was taken afte<\/span><span data-contrast=\"auto\">r vaccination, which is\u00a0<\/span><span data-contrast=\"auto\">a serious violation.\u00a0<\/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<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span data-contrast=\"auto\">Participants\u00a0<\/span><span data-contrast=\"auto\">were not given a copy of the consent form and other documents to prove their participation.<\/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<\/ul>\n<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Fourthly,<\/span><\/b><span data-contrast=\"auto\">\u00a0700<\/span><span data-contrast=\"auto\">\u00a0participants\u00a0<\/span><span data-contrast=\"auto\">in the trial were illiterate and there is no evidence that<\/span><span data-contrast=\"auto\">\u00a0an imp<\/span><span data-contrast=\"auto\">artial witness was\u00a0<\/span><span data-contrast=\"auto\">present during the entire informed consent process to\u00a0<\/span><span data-contrast=\"auto\">attach<\/span><span data-contrast=\"auto\">\u00a0his\/her signatures to the consent form.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">\u00a0<\/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 data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Fifthly<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><span data-contrast=\"auto\">communities living close to the hospital have told the media that<\/span><b><span data-contrast=\"auto\">\u00a0they were\u00a0<\/span><\/b><b><span data-contrast=\"auto\">offered\u00a0<\/span><\/b><b><span data-contrast=\"auto\">\u20b9<\/span><\/b><b><span data-contrast=\"auto\">750<\/span><\/b><b><span data-contrast=\"auto\">,<\/span><\/b><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">and\u00a0<\/span><b><span data-contrast=\"auto\">luring people in trial for money<\/span><\/b><b><span data-contrast=\"auto\">\u00a0is unethical<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-contrast=\"auto\">\u00a0<\/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<\/ul>\n<ul>\n<li data-leveltext=\"o\" data-font=\"Courier New\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span data-contrast=\"auto\">Although the company maintained that the amount was the reimbursement for the <\/span><span data-contrast=\"auto\">transportation and loss of wages, an <\/span><b><span data-contrast=\"auto\">open announcement of remuneration was unethical.<\/span><\/b><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">\u00a0<\/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<\/ul>\n<ul>\n<li data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"2\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><b><span data-contrast=\"auto\">Lastly,\u00a0<\/span><\/b><span data-contrast=\"auto\">it is not yet confirmed that<\/span><span data-contrast=\"auto\">\u00a0institutional ethics committee approved\u00a0<\/span><span data-contrast=\"auto\">the\u00a0<\/span><span data-contrast=\"auto\">advertisement<\/span><span data-contrast=\"auto\">\u00a0for<\/span><span data-contrast=\"auto\">\u00a0inviting people to the trial<\/span><span data-contrast=\"auto\">, in lieu of\u00a0<\/span><span data-contrast=\"auto\">money<\/span><span data-contrast=\"auto\">.\u00a0<\/span><span data-contrast=\"auto\">\u00a0<\/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<\/ul>\n<p><b><span data-contrast=\"auto\">Way forward<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:200,&quot;335559740&quot;:276}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0a7\" data-font=\"Wingdings\" data-listid=\"4\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">India has already\u00a0<\/span><span data-contrast=\"auto\">approved\u00a0<\/span><span data-contrast=\"auto\">2 vaccines\u00a0<\/span><span data-contrast=\"auto\">for restricted use and<\/span><span data-contrast=\"auto\">\u00a0the virus spread slowing down, so\u00a0<\/span><span data-contrast=\"auto\">enrolling<\/span><span data-contrast=\"auto\">\u00a0participants will be more challenging.\u00a0<\/span><span data-contrast=\"auto\">Therefore, a<\/span><span data-contrast=\"auto\"> thorough and impartial inquiry will bring back confidence in clinical trials.<\/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<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Synopsis:\u00a0Many issues have been highlighted in the\u00a0Phase-3 trial of\u00a0Bharat Biotech\u2019s COVID-19 vaccines. Those\u00a0issues\u00a0could have been avoided after HPV vaccine trial controversy.\u00a0 Introduction\u00a0 In a previous case,\u00a0Human papilloma virus (HPV) vaccine\u00a0trial\u00a0was carried out on nearly 23,500 girls in the 10-14 age\u00a0group\u00a0in Vadodara, Gujarat and\u00a0Khammam\u00a0without proper consent. Almost eight years later\u00a0the\u00a0Supreme Court of India\u00a0criticized\u00a0the government\u00a0for\u00a0its inability to&hellip; <a class=\"more-link\" href=\"https:\/\/forumias.com\/blog\/issues-in-the-process-of-covid-vaccine-trial\/\">Continue reading <span class=\"screen-reader-text\">Issues in\u00a0the process of\u00a0COVID Vaccine trial\u00a0<\/span><\/a><\/p>\n","protected":false},"author":61,"featured_media":76802,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"footnotes":""},"categories":[1230],"tags":[1315,1289,1456,1472],"class_list":["post-76794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-9-pm-daily-articles","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\/2021\/01\/Issues-in-the-process-of-COVID-Vaccine-trial.jpg?fit=1280%2C720&ssl=1","views":{"total":0,"cached_at":"","cached_date":1704846839},"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/76794","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=76794"}],"version-history":[{"count":0,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/posts\/76794\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media\/76802"}],"wp:attachment":[{"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/media?parent=76794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/categories?post=76794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/forumias.com\/blog\/wp-json\/wp\/v2\/tags?post=76794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}