HYDERABAD: Dr Reddy’s Laboratories on Friday said it has initiated the process for emergency use authorisation (EUA) approval with the DCGI for Russian Covid-19 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 be completed by February 21, 2021, it said in a regulatory filing with the bourses.
The vaccine candidate is currently undergoing phase 3 clinical trials in India on 1,500 volunteers as part of a bridging study to the larger global phase 3 study. The phase 2 study was conducted on 100 subjects in India.
Sputnik V demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia who received two doses of the vaccine, as per results published in reputed medical journal The Lancet.
The Russian vaccine, which is an adenoviral vector-based vaccine, maintained a consistent efficacy at 91.8% even among the 2,144 volunteers aged over 60 years, it said.
Commenting on the development, Dr Reddy’s Laboratories co-chairman and managing director G V Prasad said: “The efficacy of Sputnik V was reported to be 91.6 % by the Lancet, which is an impressive development in the fight against Covid-19. 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.”
Dr Reddy’s joined hands with Russian sovereign wealth fund Russian Direct Investment Fund (RDIF) in September 2020 for conducting clinical trials and distributing Sputnik V in India.
Sputnik V, which has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, became the world’s first Covid-19 vaccine to be registered on the human adenoviral vector programme on August 11, 2020, by the ministry of health of Russia.
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 be completed by February 21, 2021, it said in a regulatory filing with the bourses.
The vaccine candidate is currently undergoing phase 3 clinical trials in India on 1,500 volunteers as part of a bridging study to the larger global phase 3 study. The phase 2 study was conducted on 100 subjects in India.
Sputnik V demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia who received two doses of the vaccine, as per results published in reputed medical journal The Lancet.
The Russian vaccine, which is an adenoviral vector-based vaccine, maintained a consistent efficacy at 91.8% even among the 2,144 volunteers aged over 60 years, it said.
Commenting on the development, Dr Reddy’s Laboratories co-chairman and managing director G V Prasad said: “The efficacy of Sputnik V was reported to be 91.6 % by the Lancet, which is an impressive development in the fight against Covid-19. 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.”
Dr Reddy’s joined hands with Russian sovereign wealth fund Russian Direct Investment Fund (RDIF) in September 2020 for conducting clinical trials and distributing Sputnik V in India.
Sputnik V, which has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, became the world’s first Covid-19 vaccine to be registered on the human adenoviral vector programme on August 11, 2020, by the ministry of health of Russia.