Indian pharma company Dr. Reddy’s Laboratories announced that Sputnik V, a registered Covid-19 vaccine in Russia, has succeeded in a phase 2 trial in India by meeting the primary endpoint of safety.
An independent data and safety monitoring board (DSMB) has recommended the Sputnik V Covid-19 vaccine to be advanced to a phase 3 trial without making any modifications.
Furthermore, the Russian Covid-19 vaccine, which is based on human adenoviral vector platform, did not show any safety concerns, as per the DSMB.
Its phase 2 clinical trial in India was undertaken in 100 volunteers under a randomized, double-blind, parallel-group, placebo-controlled study.
Dr. Reddy’s Laboratories has filed the safety data to the Drugs Controller General of India (DCGI) for review apart from requesting the regulator’s nod for starting phase 3 trials of the Russian Covid-19 vaccine.
It can be noted that the Sputnik V vaccine was developed by Russia-based Gamaleya National Research Institute of Epidemiology and Microbiology.
In September 2020, Dr. Reddy’s Laboratories entered into a partnership with Russian Direct Investment Fund (RDIF) for bringing the Russian coronavirus vaccine to India. Subject to regulatory approval in India, the Russian sovereign wealth fund will provide 100 million doses of the vaccine to the Indian pharma company.
G V Prasad – Co-chairman and Managing Director of Dr. Reddy’s Laboratories said: “The Indian clinical trial being conducted by Dr. Reddy’s and RDIF is an adaptive design phase 2/3 trial. It is a bridging study to the larger global phase 3 study on 31,000 subjects.
“The phase 2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia and more than 300,000 people in Argentina. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India.”
Based on data analysis of the final control point of clinical trials in Russia, the Sputnik V vaccine is said to have delivered an efficacy of 91.4%.
Kirill Dmitriev – CEO of the Russian Direct Investment Fund said: “The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets. The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on safe human adenoviral vector platform.”