PremiumSputnik V meets the primary endpoint of safety in the phase-2 clinical trials in India, said Dr Reddy’s Laboratories Ltd
The company has submitted the mid-stage trial safety data to India's drug regulator for review and approval to continue late-stage trials, Dr Reddy's said in a regulatory filing.
Dr Reddy’s in a statement said that it has submitted the phase-2 safety data for Drugs Controller General of India’s approval to continue phase-3 clinical trials.
Data and safety monitoring board recommended phase 3 recruitment and continue Sputnik V clinical trial without any modifications, the statement further added.
G V Prasad, Co-chairman and Managing Director, 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."
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."
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.
In September 2020, Dr. Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India. 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 Organization’s (WHO) list.
The vaccine’s efficacy is confirmed at 91.4% 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.
Meanwhile, India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
The vaccination drive in the country is set to start from 16 January, 2021.
