{"id":10725,"date":"2021-09-03T06:02:43","date_gmt":"2021-09-03T06:02:43","guid":{"rendered":"https:\/\/i3tk.org\/demo2\/?p=10725"},"modified":"2021-09-03T06:02:45","modified_gmt":"2021-09-03T06:02:45","slug":"dcgi-gives-nod-for-phase-2-3-trials-of-biological-es-covid-vaccine-on-those-aged-between-5-18","status":"publish","type":"post","link":"https:\/\/i3tk.org\/demo2\/world-news\/resources\/dcgi-gives-nod-for-phase-2-3-trials-of-biological-es-covid-vaccine-on-those-aged-between-5-18\/","title":{"rendered":"DCGI gives nod for phase 2\/3 trials of Biological E’s Covid vaccine on those aged between 5 & 18"},"content":{"rendered":"\n

The Drugs Controller General of India (DCGI<\/a>) on Wednesday granted permission to Hyderabad-based Biological E<\/a> Limited to conduct phase 2\/3 clinical trials of its ‘Made in India’ COVID-19 vaccine<\/a> on children aged between 5 and 18 years with certain conditions, sources said.<\/p>\n\n\n\n

The phase 2 and 3 clinical trials have be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo controlled, Phase-2\/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents’, a source said.<\/p>\n\n\n\n

The trial will be conducted across 10 sites in the country.<\/p>\n\n\n\n

The DCGI’s permission was given based on the recommendations by the Subject Expert Committee (SEC) on COVID-19.<\/p>\n\n\n\n

So far, indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.<\/p>\n\n\n\n

Meanwhile, the data of phase 2\/3 clinical trials of Bharat Biotech’s Covaxin in the age group 2 to 18 years is underway.<\/p>\n\n\n\n

India’s drug regulator in July granted permission to Serum Institute of India (SII) for conducting phase 2\/3 trials of Covovax on children aged 2 to 17 years with certain conditions.<\/p>\n\n\n\n

Biological E’s anti-coronavirus shot, Corbevax, which is a RBD protein sub-unit vaccine is currently undergoing phase 2\/3 clinical trials on adults, sources had said earlier.<\/p>\n\n\n\n

Biological E will supply 30 crore doses of Corbevax to the central government by December, as announced by the Union Health Ministry in June. The ministry finalised arrangements with the Hyderabad-based vaccine manufacturer to reserve 30 crore vaccine doses, an official statement had said.<\/p>\n\n\n\n

The Biological E COVID-19 vaccine candidate has been supported by Government of India from preclinical stage to phase 3 studies. The Department of Biotechnology has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a Health Ministry statement had stated.<\/p>\n","protected":false},"excerpt":{"rendered":"

The phase 2 and 3 clinical trials have be conducted as per approved protocol titled ‘A Prospective, Randomised, Double-blind, Placebo controlled, Phase-2\/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents’, a source said.<\/p>\n","protected":false},"author":1,"featured_media":10247,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[87],"tags":[],"class_list":["post-10725","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-resources"],"yoast_head":"\nDCGI gives nod for phase 2\/3 trials of Biological E's Covid vaccine on those aged between 5 & 18 - International Institute of Innovation and Technology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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