Hyderabad: Sputnik Light, the single-dose Covid-19 vaccine, can submit Russian safety data for approval in India, Dr Reddy’s Laboratories said on Thursday.
The Hyderabad-based Dr Reddy’s, in a statement, said that the Subject Expert Committee (SEC) under Drugs Controller General of India (DCGI) asked it to submit safety, immunogenicity and efficacy data from the Phase 3 clinical trial of Sputnik Light in Russia for consideration of marketing authorisation of Sputnik Light in India.
The SEC, at its meeting on Wednesday, deliberated on the submission for marketing authorisation of Sputnik Light from Dr Reddy’s. The company presented to the SEC, interim safety and efficacy data from the Phase 1/2 clinical trial of Sputnik Light in Russia, along with a clinical trial protocol for a Phase 3 trial of Sputnik Light in India.
The SEC made the recommendation in view of the fact that 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 a Phase 3 efficacy trial is currently underway in Russia on Sputnik Light.
“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 3 trial of Sputnik Light in India,” the statement said.
Sputnik Light is a single dose Covid-19 vaccine from the makers of Sputnik V and is yet to be approved in India.