Major Indian pharmaceutical company Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) today said they have begun adaptive phase 2/3 clinical trials for the Sputnik V Covid-19 vaccine in India.
The trials have commenced after receiving the necessary clearance from the Central Drugs Laboratory, they added.
The trials will be a randomised controlled study at a number of sites across India, which will include safety and immunogenicity studies, Dr Reddy’s Laboratories, the Hyderabad-based drug maker, and RDIF said in a joint statement.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner.
Dr Reddy’s has partnered with the Indian government’s Biotechnology Industry Research Assistance Council (BIRAC) for advisory support and to use BIRAC’s clinical trial centres for the vaccine, it added.
The RDIF had recently announced the second interim analysis of clinical trial data which showed 91.4 percent efficacy for the vaccine on day 28 after the first dose and efficacy of over 95 percent 42 days after the first dose.
Currently, 40,000 volunteers are taking part in phase 3 of Sputnik V clinical trials, out of whom more than 22,000 have been vaccinated with the first dose and more than 19,000 with both the first and second doses of the vaccine, the statement added.
“We are working towards making the vaccine available with a combination of import and indigenous production model,” Dr Reddy’s Laboratories Co-Chairman and Managing Director G V Prasad said.
In September this year, Dr Reddy’s and RDIF entered a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the 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 and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vector platform.