Sputnik V human trials in India: Dr. Reddy gets permission from DCGI for Phase 2/3

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Sputnik V, the Russian COVID-19 vaccine has become a ray of hope for everyone in the darkness. It is true that the world is hanging in between a lifetime crisis. There is chaos everywhere, and the situation is just not ready to get any close to “better”. Thousands of people are dying every day due to the deadly corona virus that is all set to engulf the whole world at once.

Earlier the Indian drug regulator turned down Dr. Reddy’s Laboratories Ltd’s proposal to conduct direct Phase-3 human trials for the Russian COVID-19 vaccine Sputnik V. Though, the company and Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) have received the Drug Control General of India (DCGI) permission to conduct an adaptive Phase 2/3 human clinical trial for the Russian vaccine in India.

Dr. Reddy and RDIF said that the phase 2/3 trial will be a multi-centre; and randomized controlled study; which will include a safety and immunogenicity study. The approval was given by the subject expert committee (SEC); that advices the drug regulator on clinical trials as well as drug and vaccine approvals; at its meeting held on Friday.

Sputnik V human trials in India: Dr. Reddy gets permission from DCGI for Phase 2/3

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Dr. Reddy’ s co-chairman and managing director G V Prasad termed it as a significant development; that will allow the company to commence the clinical trials for the Sputnik V in India. He said, “We are committed to bringing in a safe and efficacious vaccine to combat the pandemic.”

RDIF CEO Kirill Dmitriev said that in addition to Indian clinical trial data, RDIF will provide safety and immunogenicity study from the Russian Phase-3 clinical trial as well. He said, “This data will further strengthen the clinical development of the Sputnik V vaccine in India.”

On 5th October 2020 at the meeting, the SEC had turned down the protocol submitted by Dr. Reddy’s to straightway conduct Phase 3 trials of the Russian vaccine in India stating that the safety; and immunogenicity data in overseas Phase 1/2 trials of the vaccine was too small; and that no data was available on Indian subjects.

While asking Dr. Reddy’s to submit a revised proposal with the protocol for conducting Phase 2 and 3 studies; the committee said that “After detailed deliberation, the committee recommended that the company should follow the regulatory requirements; and conduct Phase 2/3 clinical trial in the country with proper monitoring for humoral; and cell-mediated immune response.”

While the vaccine is currently undergoing Phase-3 clinical trials; involving 40,000 volunteers in Russia; a Phase-3 clinical trial of the vaccine has also commented in the UAE last week.

 

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