Dr. Reddy’s seeks EUA for Russian Covid-19 vaccine Sputnik V from DCGI
Dr. Reddy’s Laboratories said that it has started the process to seek the emergency use authorization (EUA) for the Russian Covid-19 vaccine Sputnik V from the Drugs Controller General of India (DCGI).
The Indian pharma company, as part of the review process, will provide the safety profile of the phase 2 trial and interim data of the phase 3 study of the human adenoviral vector-based platform vaccine candidate.
Dr. Reddy’s Laboratories expects to wrap up the phase 3 study of the Sputnik V Covid-19 vaccine by 21 February 2021.
It can be recalled that last September, Dr. Reddy’s Laboratories forged a deal with the Russian Direct Investment Fund (RDIF) to carry out the clinical trials of the Sputnik V coronavirus vaccine and for its distribution rights in India.
The Sputnik V vaccine had shown an efficacy rate of 91.6% in the interim analysis of a phase 3 clinical trial, which included data on 19,866 volunteers in Russia.
G V Prasad – Co-chairman and Managing Director of 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 was developed by the Gamaleya National Research Institute of Epidemiology and Microbiology.
It was registered in August 2020 by the Ministry of Health of Russia, making it the first approved vaccine against Covid-19 in the world based on the human adenoviral vector platform.
The Sputnik V Covid-19 vaccine has approval across 26 countries and has been administered to over two million people across the world.