Coronavirus: Dr Reddy's, RDIF begin COVID-19 vaccine Sputnik V trials in India
The Indian drug maker, in a release, said this will be a multicenter and randomised controlled study, which will include safety and immunogenicity study.
FollowHyderabad: Dr Reddy's Laboratories and the Russian Direct Investment Fund (RDIF) on Tuesday announced on Tuesday it has commenced Phase 2 and 3 clinical trials for Sputnik V in India.
The Indian drug maker, in a release, said this will be a multicenter and randomised controlled study, which will include safety and immunogenicity study.
"Dr Reddy's Laboratories Ltd and Russian Direct Investment Fund (RDIF) announced today that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study," Dr Reddy's said in a stock exchange filing.
The trials are being conducted by JSS Medical Research, being the clinical research partner. Dr. Reddy's has also joined hands with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support, as well as to use BIRAC's clinical trial centres for the vaccine.
Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose and vaccine efficacy of over 95%, 42 days after the first dose.
Currently, 40,000 volunteers are taking part in Phase III of Sputnik V clinical trials, out of which over 22,000 have been administered the first dose and more than 19,000 with the first and second doses of the vaccine.
GV Prasad, Co-chairman and Managing Director of Dr Reddy's Laboratories, said, "This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model."
Dr Reddy's and RDIF had partnered up in September 2020, so as to conduct clinical trials of the Sputnik V vaccine, as well as having the rights for distribution of its first 100 million doses in India.
The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11 this year making it the world's first registered vaccine (based on the human adenoviral vector platform) against the pandemic.
