Dr Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) on Tuesday announced the start of adaptive phase 2/3 clinical trials for COVID-19 vaccine Sputnik V in India after receiving necessary clearance from the Central Drugs Laboratory in Himachal Pradesh.
The Indian drug maker, in a release, said this will be a multicenter and randomised controlled study, which will include safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner.
Further, Dr Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory support and to use BIRAC’s clinical trial centres for the vaccine, it said.
Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4 per cent efficacy for the vaccine on day 28 after the first dose and vaccine efficacy of over 95 per cent, 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.”
In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.
On August 11, 2020, the Sputnik V vaccine developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Health Ministry and became the world’s first registered vaccine against coronavirus based on the human adenoviral vector platform.