The Drugs Controller General of India (DCGI) has approved the phase III clinical trials of Russia’s Sputnik V vaccine against Covid-19 in the country, officials said. Dr. Reddy’s Laboratories will conduct phase II and III trials, they added.
“This is an important milestone in the progress of this pivotal clinical trial of the vaccine. We expect to commence the phase III study within this month and will continue to fast-track our efforts to bring in a safe and efficacious vaccine for the Indian population,” said GV Prasad, co-chairman and managing director, Dr. Reddy’s Laboratories.
The phase III study will involve 1,500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.
Earlier, the Data and Safety Monitoring Board reviewed the safety data from the phase II clinical trial of the vaccine and recommended the phase III recruitment.
In its report, the Board concluded that no safety concerns were identified and the study met the primary endpoints of safety.
In September, Dr. Reddy’s Laboratories partnered with the Russian Direct Investment Fund to conduct the clinical trials of the vaccine and distribute its rights in India.
Sputnik V has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. It 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% 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. It has been registered in Algeria, Argentina, Belarus, Bolivia, and Serbia for inoculation.
The vaccine’s data was submitted to DCGI last week. It was examined by the Central Drugs Standard Control Organisation’s subject expert committee. On January 13, the committee recommended that phase III trials of Sputnik V can continue based on the submitted data.