India to accept single-dose vaccine Sputnik Light's trial data from Russia: Dr. Reddy's

Sputnik Light has reportedly 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," an official statement from Dr. Reddy's 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.

Earlier media reports claimed that Dr Reddy's Laboratories had been denied permission by India's top regulatory body to conduct the Phase 3 trials for Sputnik Light vaccine in India.

The expert committee of the Central Drugs Standard Control Organisation (CDSCO) refused to allow the Hyderabad-based pharmaceutical company to conduct the third phase trials for the Russian single-dose vaccine as it did not find the "scientific rationale" for it, said reports.