Sputnik V is developed by Gamaleya National Research Center and RDIF
New Delhi:
Hyderabad-based Dr Reddy’s labs have asked India’s Comptroller General of Medicines for permission to conduct phase 3 human clinical trials of Russian vaccine Sputnik V against COVID-19 in India, sources said .
The Indian pharmaceutical giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials on Sputnik V as well as its distribution.
After regulatory approval in India, RDIF will provide Dr Reddy with 100 million doses of the vaccine, the company announced last month.
“Dr. Reddy’s labs have asked DCGI for permission to conduct phase 3 human clinical trials of the Sputnik V vaccine against COVID-19 developed by Russia. DCGI will conduct a technical assessment of the request before giving its approval, ”the source said.
Sources said it would be a multicenter, observer-blind, randomized controlled study.
The phase 3 trial of Sputnik V has been underway in Russia since September 1 on around 40,000 subjects, they added.
Sputnik V was developed by the Gamaleya National Research Center in Epidemiology and Microbiology and RDIF.
Currently, two candidate vaccines, the one developed locally by Bharat Biotech in collaboration with the ICMR and the one developed by Zydus Cadila Ltd, are in phase 2 human clinical trials.
The Pune-based Indian Serum Institute, which has partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in India.
