Therapy Areas: Vaccines
Dr. Reddy's Laboratories to begin phase 3 study of Sputnik V vaccine in India
18 January 2021 -

Pharmaceutical company Dr. Reddy's Laboratories Ltd (BSE:500124) (NYSE:RDY) (NSEIFSC:DRREDDY) reported on Friday the receipt of approval from the Drugs Control General of India (DCGI) to progress the pivotal phase 3 clinical trial for the Sputnik V vaccine in India.

This approval is an important milestone in the progress of this pivotal phase 3 clinical trial of the Sputnik V vaccine and the company will conduct on 1500 subjects under the randomized, double-blind, parallel-group, placebo-controlled study in Indian population.

Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. DSMB concluded that no safety concerns were identified and the study met the primary endpoints

Dr. Reddy's Laboratories partnered with Russian Direct Investment Fund in September 2020, 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. The vaccine's efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia.