Phase 2/3 clinical trials of Sputnik V COVID-19 vaccine commence in India

New Delhi, Dec 01: Dr Reddy's Laboratories and Russian Direct Investment Fund (RDIF) on Tuesday said they have commenced 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 Kasauli-based Central Drugs Laboratory, they added.

This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study, 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. Further, Dr Reddy's has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC's clinical trial centres for the vaccine, it added.

Recently, RDIF had 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 efficacy of over 95 per cent 42 days after the first dose.

Currently, 40,000 volunteers are taking part in phase 3 of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose and more than 19,000 with both the first and second doses of the vaccine, it added.

"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 Laboratories Co-Chairman and Managing Director G V Prasad said. 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.

Earlier on August 11, 2020, the Sputnik V vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia. It became the world's first registered vaccine against COVID-19 based on the human adenoviral vector platform.