Pharmaceutical company Dr Reddy’s on Friday announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorisation (EUA) of Russian vaccine candidate, Sputnik V.
As part of the review process, Dr Reddy’s will present the safety profile of the Phase 2 study, and interim data of the Phase 3 study, which is expected to complete by February 21.
Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, is one of only three vaccines in the world with an efficacy of 91.6 per cent and has most authorisations granted with 26 countries globally.
“The efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the fight against Covid-19,” G.V. Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories, said in a statement.
“The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,” he added.
In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India.
The vaccine, based on a platform of human adenoviral vectors, is currently undergoing Phase 3 clinical trial in India.
Registered by Russia on August 11, 2020 Sputnik V became the world’s first Covid-19 vaccine.