Dr. Reddy's To Conduct Trial For Russian Covid Vaccine In India
DRL today announced that it had received approval from the DCGI to conduct adaptive phase 2/3 human clinical trials for Russia's Sputnik V vaccine in India.
Hyderabad | 17th October 2020
Dr. Reddy's Laboratories Ltd and Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, today announced that they had received approval from the Drug Control General of India (DCGI) to conduct adaptive phase 2/3 human clinical trials for Russia's Sputnik V vaccine in India.
This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity studies.
Earlier, in September 2020, Dr. Reddy's and RDIF had entered a partnership to conduct clinical trials of Sputnik V and distribute it in India. As part of the partnership, RDIF is to supply 100 million doses of the vaccine to Dr. Reddy's upon regulatory approval in India.
G V Prasad, Co-Chairman and Managing Director, Dr. Reddy's Laboratories, said, "This is a significant development that allows us to commence the clinical trial in India, and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic."
On August 11, 2020, Sputnik V, a purported Covid-19 vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia, and became the world's first registered vaccine against Covid-19.
Sputnik V is currently undergoing phase 3 clinical trials in Russia, and the proposed number of subjects is 40,000. Additionally, another phase 3 clinical trial of the vaccine commenced in the UAE last week.
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