New Delhi: Dr Reddy’s Laboratories Ltd announced that it has initiated the process for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate Sputnik V, with the Drugs Controller General of India (DCGI).
As part of the review process, Dr. Reddy’s will present the safety profile of the phase two study and interim data of the phase three study, which is expected to be complete by 21 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 three clinical trial in India.
Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the phase three 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.
“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,” said G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories.