India to accept 1-Dose Sputnik Light Trial Data from Russia

The makers of the first shot of Russian-made Sputnik V vaccine, Sputnik Light says that it demonstrated an efficacy of 79.4 per cent.

Russian Phase 3 trial data for the single-dose Sputnik Light COVID-19 shot in India can be submitted said a government expert panel. Hours after reports came out that stated that they had been denied approval for the trial in India, Dr. Reddy’s, the vaccine’s India partner reported on Thursday.

The makers of the first shot of the Russian-made Sputnik V vaccine, Sputnik Light claim that it demonstrated the efficacy of 79.4 percent.

Advertisement

The company said in a statement, “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. 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.”

Dr. Reddy’s also said that the SEC also observed that 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 keeping the safety and immunogenicity data already generated in view.

In May, Dr. Reddy had told NDTV that the Russian vaccines can become the first single-dose vaccine to be used if approved.