A government expert panel has said that Russian Phase 3 trial data for the single-dose Sputnik Light COVID-19 shot in India can be submitted, the vaccine’s India-partner Dr Reddy’s said on Thursday, hours after reports said they had been denied approval for the trial in the country.
“On Wednesday 30th June, 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 V in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India,” it added.
“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 (in other words, Sputnik Light), there was no need for a separate Phase III trial of Sputnik Light in India,” Dr Reddy’s said.
News agency ANI had earlier reported that Dr Reddy’s Laboratories had been denied permission by India’s top regulatory body to conduct the Phase 3 trials for the Russian-made Sputnik Light vaccine in India, citing people familiar with the development.