New Delhi: Sputnik’s single-dose COVID-19 vaccine, Sputnik Light, has received the approval of the Drugs Controller General of India (DCGI) to conduct phase III bridging trials on the Indian population.
The Subject Expert Committee (SEC) of the DCGI recommended the phase III bridging trials for Sputnik Light, India Today reported.
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 noting that it was the same as component-1 of Sputnik V and as its safet
y and immunogenicity data in the Indian population was already generated in a trial.
Dr Reddy’s Laboratories had partnered with the Russian Direct Investment Fund (RDIF) last year to conduct the phase III trials of Sputnik V vaccine in India. Dr Reddy’s was asked by the SEC to submit the safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik-Light in Russia for the market authorisation of the single-shot vaccine in India.
About Sputnik Light
- A recent study published in The Lancet showed that Sputnik Light showed 78.6-83.7 per cent efficacy against COVID-19, significantly higher than most two-shot vaccines. 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.
- Sputnik Light has been developed by Russia’s Gamaleya Institute and backed by RDIF.