Covid-19 vaccine: Dr Reddy s to start Sputnik V trials in India

     Written by : SMTV24x7 | Mon, Oct 19, 2020, 12:53 PM

Covid-19 vaccine: Dr Reddy s to start Sputnik V trials in India

Sputnik V promoter Russian Direct Investment Fund and Dr Reddy's Laboratories announced that they have been granted approval from the Drug Control General of India to conduct an adaptive phase 2 and 3 human clinical trial for the vaccine in the country. Russia's Sputnik V has become the fourth Covid-19 vaccine candidate in India to receive regulatory permission for human trials.

The regulator had then directed Dr Reddy's to submit a revised proposal for phase 2 and 3 trial in the country. In September, Dr Reddy's and RDIF had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF plans to supply 100 million doses of the vaccine to Dr Reddy's upon regulatory approval in India.

Sputnik V is currently undergoing phase 3 clinical trials in Russia and the proposed number of subjects is 40,000. Additionally, a phase 3 clinical trial of the vaccine commenced in the UAE last week.

Commenting on the development, GV Prasad, co-chairman and managing director, Dr Reddy's said this was a significant development that allows them to start the clinical trials, adding that his company was committed to bringing in a safe and efficacious vaccine to combat the pandemic.

RDIF CEO Kirill Dmitriev said, "We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial."

Dmitriev added that this data would further strengthen the clinical development of Sputnik V vaccine in India.

In August, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered in Russia and had become the world's first registered vaccine against Covid-19.