BackDr Reddy’s to finish Sputnik V trial by May
Dr Reddy’s will soon start enrolling 100 participants for the phase 2 clinical trial of the vaccine, and after getting the approval to continue, recruit 1,400 subjects for phase 3, CEO Erez Israeli said
PremiumNEW DELHI : Dr Reddy’s Laboratories Ltd Wednesday said it plans to complete the phase 3 clinical trials of the Sputnik V covid-19 vaccine by May, and prepare for approval from the Drug Controller General of India (DCGI).
“Phase 2, I hope will be finished by December, which means not just the enrolment and the trial, but also compilation of the results and, hopefully, also get positive response from the authorities that we can continue (the trial)… It (completion of phase 3) can be as early as end of March to April or May," chief executive officer Erez Israeli said in a virtual press conference on Wednesday.
Dr Reddy’s will soon start enrolling 100 participants for the phase 2 clinical trial of the vaccine, and after getting the approval to continue, recruit 1,400 subjects for phase 3, Israeli said.
He said the company and its partner Russian Direct Investment Fund (RDIF) is in talks with vaccine manufacturers to produce and supply the covid-19 vaccine.
Israeli, however, did not give details on tentative pricing of the vaccine.
The company received DCGI approval earlier this month to conduct an adaptive phase 2 and 3 clinical trial of the Sputnik V vaccine, which has been co-developed by RDIF and Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology.
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