The Drugs Controller General of India (DCGI) has given approval to Dr Reddy’s Laboratories to conduct phase 3 clinical trials of Russia’s Covid-19 vaccine candidate, Sputnik V, in the country.
The phase 3 trial will be conducted on 1,500 subjects as part of the randomised, double-blind, parallel group, placebo controlled study in India, Dr Reddy said in a statement here on Friday.
Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trials of the vaccine and recommended phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified and the study met the primary endpoints of safety.
Dr Reddy’s Laboratories co-chairman and MD GV Prasad said, “This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence phase 3 study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population”.
In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights 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.
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.
Sunday, 17 January 2021 | PNS | New Delhi
