Don't need Phase 3 trials, Sputnik Light vaccine can submit Russian safety data in India: Dr Reddy's
New Delhi [India], July 1 (ANI): Sputnik vaccine's India-partner Dr Reddy's on Thursday informed that the government panel has told the pharma firm that it does not need to conduct Phase 3 trials for Sputnik Light and only require to submit Russian safety data for approval in India.
ANI
Jul 01, 2021 22:16 IST
By Shalini Bhardwaj
New Delhi [India], July 1 (ANI): Sputnik vaccine's India-partner Dr Reddy's on Thursday informed that the government panel has told the pharma firm that it does not need to conduct Phase 3 trials for Sputnik Light and only require to submit Russian safety data for approval in India.
"Sputnik Light can submit Russian safety data in India," Dr Reddy's said.
The first shot of the Russian-made Sputnik V vaccine Sputnik Light has demonstrated the efficacy of 79.4 per cent, a statement issued by Dr Reddy's said.
"On Wednesday, June 30, the SEC (Subject Expert Committee) deliberated on the submission for Marketing Authorisation of Sputnik Light in India from Dr Reddy's. The company presented to the SEC, interim safety and efficacy data from the Phase I / II clinical trial of Sputnik Light in Russia, along with a clinical trial protocol for a Phase III trial of Sputnik Light in India," the company said in a statement.
"In view of the fact that (1) Sputnik Light is the first dose component of Sputnik V, and Dr Reddy's has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and; (2) a phase III efficacy trial is currently underway in Russian on Sputnik Light, the SEC recommended that Dr Reddy's should submit safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik Light in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India," it said.
Further, the SEC also observed that in view of the safety and immunogenicity data already generated by Dr Reddy's in India on the first dose component of Sputnik V, there was no need for a separate Phase III trial of Sputnik Light in India. (ANI)
Tags:
Get the App
