{"id":169106,"date":"2021-08-14T00:12:02","date_gmt":"2021-08-13T18:42:02","guid":{"rendered":"https:\/\/arunachaltimes.in\/?p=169106"},"modified":"2021-08-14T00:12:02","modified_gmt":"2021-08-13T18:42:02","slug":"bharat-biotechs-covid-nasal-vaccine-gets-regulators-nod-for-holding-phase-2-clinical-trial","status":"publish","type":"post","link":"https:\/\/arunachaltimes.in\/index.php\/2021\/08\/14\/bharat-biotechs-covid-nasal-vaccine-gets-regulators-nod-for-holding-phase-2-clinical-trial\/","title":{"rendered":"Bharat Biotech\u2019s Covid nasal vaccine gets regulator\u2019s nod for holding phase 2 clinical trial"},"content":{"rendered":"<p style=\"text-align: justify;\">\nNew Delhi, Aug 13 (PTI): The first nasal vaccine against COVID-19, developed by Bharat Biotech, has received regulator\u2019s nod for conducting phase 2 clinical trial, the Department of Biotechnology said on Friday.<\/p>\n<p style=\"text-align: justify;\">Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years, it said.<\/p>\n<p style=\"text-align: justify;\">\u201cBharat Biotech\u2019s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for phase 2 trials,\u201d the DBT said in a revised statement.<\/p>\n<p style=\"text-align: justify;\">In a statement issued earlier, the DBT had said the regulator\u2019s nod was given for phase 2 and 3 clinical trials.<\/p>\n<p style=\"text-align: justify;\">The regulatory approval has been received for conducting \u201ca Phase 2 randomised, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in healthy volunteers\u201d.<\/p>\n<p style=\"text-align: justify;\">This is the first of its kind COVID-19 jab to undergo human clinical trials in India, it said.<\/p>\n<p style=\"text-align: justify;\">BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.<\/p>\n<p style=\"text-align: justify;\">\u201cThe company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial have been well tolerated. No serious adverse events reported,\u201d the DBT said.<\/p>\n<p style=\"text-align: justify;\">Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralising antibodies in animal studies, it added.<\/p>\n<p style=\"text-align: justify;\">The Mission COVID Suraksha was launched to accelerate COVID-19 vaccine development efforts as part of the third stimulus package, Atmanirbhar 3.0.<\/p>\n<p style=\"text-align: justify;\">The focus of this mission is to consolidate and streamline available resources towards a warpath for accelerated vaccine development in order to bring a safe, efficacious, affordable and accessible COVID-19 vaccine to the citizens at the earliest.<\/p>\n<p style=\"text-align: justify;\">\u201cThe department, through Mission COVID Suraksha, is committed to development of safe and efficacious COVID-19 vaccines. Bharat Biotech\u2019s BBV154 Covid vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,\u201d Renu Swarup, Secretary, DBT and Chairperson, BIRAC said.<\/p>\n<p style=\"text-align: justify;\">\n","protected":false},"excerpt":{"rendered":"<p>New Delhi, Aug 13 (PTI): The first nasal vaccine against COVID-19, developed by Bharat Biotech, has received regulator\u2019s nod for conducting phase 2 clinical trial, the Department of Biotechnology said on Friday. Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years, it said. \u201cBharat Biotech\u2019s intranasal vaccine is [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":{"0":"post-169106","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-national"},"_links":{"self":[{"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/posts\/169106","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/comments?post=169106"}],"version-history":[{"count":0,"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/posts\/169106\/revisions"}],"wp:attachment":[{"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/media?parent=169106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/categories?post=169106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/arunachaltimes.in\/index.php\/wp-json\/wp\/v2\/tags?post=169106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}