West Bengal Hospital to start Phase II trial of Russia's COVID-19 vaccine on approval from DGCI
West Bengal Hospital to start Phase II trial of Russia's COVID-19 vaccine on approval from DGCI
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The health department senior official has said, "If all goes well, Phase-II clinical trials of Russian vaccine Sputnik V will commence at state government-run College of Medicine and Sagore Dutta Hospital by the end of this month". The site management organisation have carried out the pre-requisite checks including hospital visit to check the infrastructure and cold storage facilities before starting the next phase process. 

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CliniMed LifeSciences, the site management organisation was involved in the process check. Snehendu Koner, the head of business development at CliniMed LifeSciences, said a report on survey findings has been sent to the Drug Control General of India (DCGI) for approval. He said, "We have visited the site, conducted checks on its infrastructure as well as facilities for storing vaccines and immunogenicity samples. We have also gone through the hospital's records and found it has experiences of conducting clinical trials. Our findings are quite satisfactory and we have sent it to the DCGI for approval". 

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Upon DCGI approval, the hospital's ethics committee will issue a clearance to start the Phase-II clinical trials at the concerned hospital. The principal investigator and the co-investigator for the process are identified. Sputnik V trials across India will be carried out by the pharma company Dr Reddy's Lab along with the Russian Direct Investment Fund (RDIF). RDIF will supply 100 million doses of teh vaccine to Dr Reddy's Lab. For the trials, 100 volunteers will be chosen, of which 75 are given the vaccine and 25 others will be given placebo. 

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