The Drug Controller General of India (DGCI) has finally approved Dr. Reddy’s to perform a phase 2 and 3 clinical human trial of Sputnik V, the COVID-19 vaccine which made Russia the first country to develop a vaccine.
The DCGI had earlier struck down the first proposal for the same from Dr. Reddy’s, which is an Indian multinational pharmaceutical company located in southern India.
“This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study,” a joint statement issued by Dr. Reddy’s and Russian Direct Investment Fund (RDIF) said.
The DCGI posed concerns about Dr. Reddy’s initial plan to test it among a larger population in India, because Sputnik V was tested only on a limited number of people in Russia before it was registered as a vaccine. Sputnik V is presently undergoing a phase 3 post-registration clinical trial involving 40,000 participants.
Dr. Reddy and RDIF entered into a collaboration in September to undertake clinical trials and distribution of the Sputnik V vaccine in India. India will get 100 million doses of Sputnik as part of the partnership.
“We acknowledge DCGI’s scientific rigors and guidance in the entire process. 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,” G V Prasad, co-chairman and managing director, Dr. Reddy’s Laboratories, said.
The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health on August 11 and became the world’s first registered human adenoviral vector platform-based vaccine against COVID-19.
In Russia, a second vaccine has been registered named EpiVacCorona. The third vaccine was approved to perform the first and second phases of clinical trials at the medical facilities of various cities in Russia including Novosibirsk, St Petersburg and Kirov medical facilities. On October 6, 15 volunteers were inoculated with this vaccine during the first stage.
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