Dr Reddy's labs begins Sputnik V Emergency Use Authorization process

Hyderabad: Drug major, Dr. Reddy's Laboratories Ltd., has recently announced that the company 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 2st February 2021.

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% 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% even among the group of 2, 144 volunteers over 60 years old.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy's Laboratories 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.

Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on 11th August 2020 and became the World's first registered vaccine against COVID-19 based on the human adenoviral vector platform.

More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. Sputnik V is one of only three vaccines in the world with an efficacy of 91.6% and has most authorizations granted with 26 countries globally. The vaccine has already been administered to more than 2 million people worldwide.