India Approves Sputnik V Vaccine Phase 3 Study

The Drugs Control General of India (DCGI) has given Hyderabad-based Dr. Reddy’s Laboratories Ltd. approval to conduct a randomized, double-blind, parallel-group, placebo-controlled phase 3 study for the Sputnik V vaccine in India.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories announced in a statement issued on January 15, 2021, “We expect to commence the 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”.

Earlier, India's 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. The DSMB concluded on January 11, 2021, that no safety concerns were identified and the study met the primary endpoints of safety.

The COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus. Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.