NEW DELHI: Russia's Sputnik V has become the fourth COVID-19 vaccine candidate in India to receive regulatory permission for human trials. The vaccine’s promotor Russian Direct Investment Fund and Dr Reddy's Laboratories on Saturday 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.
It will be a multi-centre and randomised controlled study, which will include safety and immunogenicity study though details of the number of volunteers and sites involved in the trial have not been disclosed yet.
Earlier this month, the COVID-19 subject expert committee of the Central Drugs Standards Control Organisation had rejected a proposal by the two firms to directly conduct phase 3 trial for the potential vaccine in India saying that the sample size for early human trials for the vaccine were "small".
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 Saturday’s 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.