Dr Reddy’s initiates process for EUA of 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 2, 2021
Dr Reddy’s Laboratories announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform 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 2, 2021.
In a statement, the company informed, “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 is currently undergoing the phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old.”
GV Prasad, Co-chairman and MD, Dr Reddy’s Laboratories said, “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. 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.”
Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020.