The Drugs Controller General of India (DCGI) on Wednesday granted a go-ahead for conducting Phase III bridging trials of single-dose Russian Covid-19 vaccine “Sputnik Light” on the Indian population.
The approval follows a recent study published in the medical journal The Lancet that said the Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines.
Earlier in July, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had refused to grant emergency-use authorisation to Sputnik-Light.
It had ruled out the need for the conduct of the phase III trial of the Russian vaccine in the country, sources said.
The committee had noted that Sputnik Light was the same as component-1 of Sputnik V and its safety and immunogenicity data in the Indian population was already generated in a trial.
The study was conducted on at least 40,000 elderly people in Argentina. Sputnik Light also reduced hospitalisations among the target population at 82.1-87.6 per cent, the study said.
The Russian Direct Investment Fund (RDIF) last year partnered with Dr Reddy’s Laboratories to conduct the phase III trials of Sputnik V vaccine in India. In April, Sputnik V received an emergency use authorisation in India. Reddy’s administered the first dose of the vaccine in Hyderabad under a limited pilot on May 14.