Sputnik V meets primary endpoint of safety in phase 2 clinical trial in India
Jan 12, 2021
Hyderabad (Telangana) [India], January 12 : Dr Reddy's Laboratories has said that independent Data and Safety Monitoring Board (DSMB) reviewed the safety data from phase two clinical trial of Russia's Covid-19 vaccine Sputnik V and recommended phase three recruitment along with continuing clinical trial without any modifications.
The phase two study of Sputnik V was conducted on 100 subjects as part of randomised, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety.
Besides, the safety data has been submitted to the Drugs Controller General of India (DCGI) for review and approval to continue phase three clinical trials.
"This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 10 lakh people in Russia and more than three lakh people in Argentina," said G V Prasad, Co-chairman and Managing Director of Dr Reddy's Laboratories.
"We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India."
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said the safety data from phase two clinical trial from India is very positive, and confirms the safety profile of Sputnik V in 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," he said.
In September 2020, Dr Reddy's and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and rights for distribution in India.
