DRL gets DCGI’s nod to conduct COVID-19 vaccine phase 2/3 human trials

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PTI

Hyderabad

Dr Reddys Laboratories Ltd (DRL) and Russian Direct Investment Fund, Russia’s sovereign wealth fund, on Saturday, announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.

The city-based drug maker said in a press release that this will be multi-centre and randomised controlled study, which will include safety and immunogenicity study.

G V Prasad, co-chairman and managing director, Dr Reddys, 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.”

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, 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.     This data will further strengthen the clinical development of Sputnik V vaccine in India.”

On August 11, 2020, the Sputnik V 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 based on the human adenoviral vectors platform.

Sputnik V is currently undergoing Phase 3 clinical trials in Russia and the proposed number of subjects is 40,000.

Additionally, phase 3 clinical trial of the vaccine commenced in the UAE last week.