Hyderabad: Pharma major Dr. Reddy’s Laboratories Ltd on Friday 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 21, the Hyderabad-based firm said.
Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF) in September 2020 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 percent 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 percent even among the group of 2,144 volunteers over 60 years old. “The efficacy of Sputnik V was reported to be 91.6 percent 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,” said G.V. Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories.
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, 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 percent and has most authorizations granted with 26 countries globally. The vaccine has already been administered to more than two million people worldwide.
