Marketing authorisation of sputnik light - Latest News Update, Information, Photos & Videos on Marketing authorisation of sputnik light at Lokmat Times

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.( With inputs from ANI )Disclaimer: This post has been auto-published from an agency feed without any modifications to the text and has not been reviewed by an editor

Home

City

Latest News

Cricket

LT Premium

National

International

Maharashtra

Opinions

Chhatrapati Sambhajinagar

Nagpur

Entertainment

Photos

Business

Technology

Sports

Lifestyle

Social Viral

Lokmat Games

Health

Pahalgam Terror Attack

Tahawwur Rana

IPL 2025

CM Devendra Fadnavis

Mumbai Local

Weather Update

Marketing Authorisation Of Sputnik Light, NewsFOLLOW

Marketing authorisation of sputnik light, Latest News

National :Don't need Phase 3 trials, Sputnik Light vaccine can submit Russian safety data in India: Dr Reddy's

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. ...