By Administrator _India
The Drug Controller General of India on October 17 gave Dr Reddy’s Laboratories the permission to conduct late-stage clinical trials for Russia’s COVID-19 Sputnik V vaccine in the country.
The nod came after the Hyderabad-based company submitted a reworked application to the Drugs Controller General of India (DCGI) on October 13 with more information on phase 2 and 3 trials.
Developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the Russian Direct Investment Fund, Sputnik V is based on a modified human adenovirus as the vector which carries the SARS-CoV-2 virus protein.
Dr Reddy’s trials will be a multi-centre and randomised controlled study on 1,500 volunteers and will include safety and immunogenicity study.