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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.

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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.

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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.

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    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.

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