The Drugs Controller General of India has greenlighted Phases II and III of Sputnik V's clinical trials in India, the Russian Direct Investment Fund said Saturday.
The fund noted that India will carry out multicentre, randomised controlled trials, which will include tests for safety and immunological potency.
"We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity data from the Russian Phase III clinical trial. This data will further strengthen the clinical development of the Sputnik V vaccine in India", Kirill Dmitriev, the RDIF CEO, said as quoted in a press release.
Co-chairman and Managing Director of Dr Reddy’s Laboratories, G. V. Prasad, has applauded the controller's approval of the trials in India.
"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", the executive said.
The RDIF and Dr Reddy’s entered into a partnership to conduct clinical trials for the Russian coronavirus vaccine in India in September. As part of the cooperation, the RDIF will supply 100 million vaccine doses to Dr Reddy's upon regulatory approval in India.
Russia registered the world's first coronavirus vaccine, developed by the Gamaleya Institute, in August. It is now completing Phase III of clinical trials in Russia as per the WHO's protocols.
In addition, the RDIF, together with its partners, is conducting Sputnik V clinical trials in Belarus, the United Arab Emirates, and Venezuela.
India is conducting trials for three COVID-19 vaccine candidates, including two domestically developed. The Serum Institute of India, in turn, is completing Phase II of clinical trials for the Oxford vaccine. India is cooperating in vaccine development with five pharma companies, including AstraZeneca and Novavax.