Coronavirus vaccine update: Phase 2 trial of Sputnik V may resume in India soon
New Delhi, Oct 17: In a positive development, India is likely to resume phase 2 clinical trials of the Russian COVID-19 vaccine, Sputnik V soon.
An expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting permission to Dr Reddy's Laboratories for conducting phase 2 clinical trials of the vaccine.
The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI), seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.
The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V vaccine for Covid-19.
Upon regulatory approval in India, RDIF shall supply Dr. Reddy's with, 100 million doses of the vaccine, the firm had announced last month.
Meanwhile, phase-3 trials of Sputnik V are currently underway in Russia since September 1 on 40,000 subjects. Sputnik V has been jointly developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF.
Currently two indigenously developed vaccine candidates for Covid-19, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd, are undergoing phase 2 of human clinical trials.
Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine is also conducting phase 2 and phase 3 human clinical trials in India.