Dr Reddy’s Laboratories is all set to conduct a Phase III clinical trial of the Covid-19 vaccine, Sputnik V, after it received approval from the Drugs Control General of India (DCGI).
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, Sputnik V is based on the established human adenoviral vector platform.
The randomised, double-blind, parallel-group, placebo-controlled study will be carried out on 1,500 participants in India.
Earlier, the Data and Safety Monitoring Board (DSMB) had advised initiating the Phase III recruitment after it reviewed the safety data from the Phase II trial of the vaccine.
The DSMB said in its report that no safety concerns relating to the vaccine were noted and the study had met the primary safety endpoints.
Dr Reddy’s Laboratories co-chairman and managing director G V Prasad said: “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 bringing in a safe and efficacious vaccine for the Indian population.”
Last September, the company had collaborated with Russian Direct Investment Fund (RDIF) to carry out the clinical trials of the Sputnik V vaccine and for its distribution rights in India.
According to the data analysis of the final control point of Russian clinical trials, the vaccine’s efficacy was noted at 91.4%.
At present, Sputnik V is registered in Algeria, Argentina, Belarus, Bolivia and Serbia for vaccination, while clinical trials of the vaccine are progressing in the UAE, Egypt, Venezuela and Belarus.
Last December, Dr Reddy’s and RDIF initiated adaptive Phase II/III clinical trials for Sputnik V vaccine in India.