New Delhi: Having refused permission earlier, the Drugs Controller General of India (DCGI) has now allowed Dr Reddy’s to conduct phase 2/3 clinical human trials of Russia’s Sputnik V vaccine candidate.
“This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study,” said a joint statement issued by Dr Reddy’s and Russian Direct Investment Fund (RDIF).
Sputnik V vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, was registered by Russia’s Ministry of Health of Russia on August 11 to become the world’s first registered vaccine against COVID-19.
Dr Reddy’s had entered into a partnership with RDIF to conduct clinical trials of Sputnik V vaccine and its distribution in India. According to the agreement, India is to get 100 million doses of Sputnik.
But since it was tested on a small number of people in Russia, DCGI had initially expressed doubts over the Sputnik V vaccine candidate being tested among a bigger population in India. But now DCGI has agreed to Dr Reddy’s proposal.
“We acknowledge DCGI’s scientific rigour 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,” said G V Prasad, co-chairman and managing director, Dr Reddy’s Laboratories.
Russia has registered a second vaccine — EpiVacCorona, while a third vaccine has received permission to conduct first and second stages of clinical trials at medical facilities in Novosibirsk, St Petersburg and Kirov.