Dr Reddy's Laboratories on Monday said the Data and Safety Monitoring Board (DSMB) has recommended recruitment for the phase 3 clinical trials of Sputnik V vaccine for COVID-19. The DSMB has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continuation of the clinical trial without any modifications, the Hyderabad-based drug major said in a statement.
A DSMB is a group of individuals which reviews on a regular basis the accumulating data from an ongoing clinical trial. It is usually appointed by the sponsor and advises it regarding the continuing safety of trial subjects. In September last year, Dr Reddy's and the Russian Direct Investment Fund (RDIF) had entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution in India.
"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 one million people in Russia and more than 3,00,000 people in Argentina," Dr Reddy's Laboratories Co-chairman and Managing Director G V Prasad said. The company is now working closely towards fast-tracking the launch of the Sputnik V vaccine in India, he added.
The phase 2 study of Sputnik V was conducted on 100 subjects as part of the 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, Dr Reddy's Laboratories said. Further, the safety data has been submitted to the Drugs Controller General of India (DCGI) for review and approval to continue phase 3 clinical trials, it added.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner in India. Dr Reddy's has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support, THSTI (Translational Health Science and Technology Institute) for further immunogenicity data characterisation, and to use BIRAC's clinical trial centres for the vaccine. "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," RDIF CEO Kirill Dmitriev said. Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the established human adenoviral vector platform.
It currently ranks among top 10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organisation's list. The vaccine's efficacy is confirmed at 91.4 per cent based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine's clinical trials are underway in the UAE, Egypt, Venezuela and Belarus, while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.
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