Russia’s Sputnik V gets DCGI nod for phase 3 clinical trials in India

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New Delhi: As India began the largest COVID vaccination drive in the world, with Covishield and Covaxin being the first two COVID vaccines being used in the country, another good news has just come in. Russia’s COVID vaccine candidate, named Sputnik V, has received DCGI approvals for phase 3 trials in India. The vaccine is being tested and produced by Dr Reddy’s Laboratories, Hyderabad, in India.

As per latest reports, Dr Reddy’s Lab issued a statement on Friday evening stating that they have received permission to conduct phase 3 clinical trials of Sputnik V, by the regulatory body DCGI.

The phase 3 study of Sputnik V will be conducted on 1,500 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in the country, the Hyderabad-based firm said in a regulatory filing, reported news agency PTI.

Earlier this week, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended phase 3 recruitment.

In its report, the DSMB had said that no safety concerns with respect to the vaccine were identified in the phase 2 trials of Sputnik V.

“This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase III study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population,” Dr Reddy’s Laboratories Co-chairman and Managing Director G V Prasad said.

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology is already approved for use in Russia and a few other countries. The vaccine became the first registered vaccine against COVID-19 around the world, when Russia registered it for public use on August 11, 2020. The vaccine is based on the established human adenoviral vector platform.

As per latest reports, Sputnik V is 91.4 per cent effective against COVID-19. Trials for the vaccine are also underway in AUE, Egypt and other countries, including India.

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