PremiumNEW DELHI : Dr Reddy’s Laboratories has started the phase 2 and 3 clinical trial of the Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory at Kasauli, the Hyderabad-based drugmaker said in a statement.
The multicentre and randomized controlled trial, which will include safety and immunogenicity study of the vaccine developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, will be conducted by JSS Medical Research as the clinical research partner, Dr Reddy’s said.
Dr Reddy’s has also 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.
The company plans to enrol 100 participants for phase 2 and 1,400 for the last stage. The company expects to complete the trials earliest by March, with regulatory approvals and launch likely in the following month, subject to success in the trials, Dr Reddy’s chief executive officer Erez Israeli had said on 28 October.
Dr Reddy’s had in September entered into a partnership with co-developer Russian Direct Investment Fund (RDIF), through which the drugmaker would conduct clinical trials of the Sputnik V vaccine in India and, after regulatory approval, distribute the first 100 million doses in the country.
“We are working towards making the vaccine available with a combination of import and indigenous production model," said Dr Reddy’s co-chairman and managing director G.V. Prasad in the statement.
Last week, RDIF announced that Hetero Biopharma Ltd has agreed to contract manufacture more than 100 million doses every year of Russia’s Sputnik V vaccine against covid-19 in India.
Under the agreement with RDIF, Hetero will start producing the vaccine from early next year, the sovereign wealth fund said.
Hetero is likely to manufacture the vaccine primarily for the Indian market, but will not have distribution rights
In August, after a 76-participant phase 1 and 2 trial in Russia by Gamaleya, Sputnik V was registered by the Ministry of Health of Russia, making it the world’s first registered vaccine against covid-19.
Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine a week after the second and final dose. Preliminary data showed that the vaccine efficacy was over 95% three weeks after the final dose. The final dose is given 21 days after the first dose.
Never miss a story! Stay connected and informed with Mint. Download our App Now!!
