Dr Reddy’s initiates EUA process with DCGI for Sputnik V

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Dr Reddy’s Laboratories Ltd has announced that it has initiated the process with the Drugs Controller General of India (DCGI) for emergency use authorisation (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 was expected to complete by February 21, 2021. The vaccine is currently undergoing the phase 3 clinical trial in India. 

GV Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “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.”