India to accept one dose Sputnik light trial data from Russia
New Delhi : A government expert panel has said that Russian Phase 3 trial data for single dose Sputnik light India can be submitted. The vaccine's India partner Dr Reddy confirmed the development, hours after some media reports claimed that they had been denied approval for the trial in the country.
Essentially the first shot of the Russian-made Sputnik V vaccine, Sputnik Light has demonstrated an efficacy of 79.4 per cent, according to its makers.
"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 the single dose Sputnik light has been denied permission to conduct phase 3 trials in India.