Hyderabad-based Dr. Reddy’s Laboratories has received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trials for Russia’s Sputnik-V Covid-19 vaccine candidate in India.
As India began the largest COVID vaccination drive in the world, with Covishield and Covaxin being the first two COVID vaccines being used in the country, another good news has just come in.
The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.
Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial 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.
GV Prasad, Co-chairman, and Managing Director of Dr. Reddy’s Laboratories. Said “We expect to commence Phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population,”
About the Vaccine
Gamaleya National Research Institute of Epidemiology and Microbiology developed Sputnik-V and was registered by Russia’s health ministry to become the world’s first registered vaccine against Covid-19 based on the established human adenoviral vector platform.
In September 2020, Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik-V and for its distribution rights in India.
The vaccine’s efficacy is confirmed at 91.4 percent 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.
Currently, Pfizer is providing vaccines worldwide, but with Sputnik-V in the picture, vaccination can be done more quickly and the world can be restored more rapidly.