Dr. Reddy’s Laboratories Ltd. stated that the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the Sputnik V vaccine phase 2 clinical trial and has recommended phase 3 recruitment and to continue the trial without any changes.

The phase 2 study was carried out on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. According to the DSMB, there appeared to be no safety concerns and the study met the primary endpoints of safety. The safety data has been submitted to the Drugs Controller General of India (DCGI) for review and approval for continuation of the phase 3 clinical trials… (ET Healthworld, January 11, 2021)