Vaccine replace for Covid-19: DCGI approves Dr. Reddy & # 39; s Lab on people with the Sputnik V vaccine
Dr. Reddys Laboratories and the Russian Direct Investment Fund announced on Saturday that they had received approval from the Indian Drug Control General to conduct a phase 2/3 adaptive human clinical trial for Sputnik vaccines in India. The city-based drug maker said in a press release that this will be a multicenter, randomized controlled trial that will include a safety and immunogenicity study.
GV Prasad, Co-Chair and MD, DRL said, "This is a significant development that will allow us to begin clinical trial in India and we are determined to introduce a safe and effective vaccine to fight the pandemic."
Kirill Dmitriev, CEO of RDIF, said, “We are excited to be working with Indian regulators and, in addition to the data from the Indian clinical trial, we will provide safety and immunogenicity studies from the Russian Phase 3 clinical trial. These data will further bolster the clinical development of the Sputnik V vaccine in India. "
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