Hyderabad: Dr Reddy’s Laboratories and its Russian partner Russian Direct Investment Fund have commenced adaptive phase 2/3 clinical trials for Russian Covid-19 vaccine Sputnik V in the country.
JSS Medical Research was roped in as clinical partner to conduct the multi-centre and randomised controlled study that includes safety and immunogenicity study, Dr Reddy’s and RDIF said in a joint statement.
Dr Reddy’s had also partnered with the Biotechnology Industry Research Assistance Council (Birac) of the Department of Biotechnology (DBT) for advisory support and to use Birac’s clinical trial centres for the vaccine.
The adaptive phase 2/3 clinical trials for Sputnik V in India were commenced after receiving the necessary clearances from the Central Drugs Laboratory at Kasauli, the statement said.
This comes close after RDIF announced that the second interim analysis of clinical trial data showed 91.4% efficacy for the vaccine on day 28 after the first dose and over 95% efficacy 42 days after the first dose. While 40,000 volunteers are currently taking part in phase 3 clinical trials ofSputnik V vaccine, over 19,000 volunteers were vaccinated with both the first and second doses of the vaccine.
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