Sputnik’s Single-Dose Vaccine Gets DCGI Nod For Phase-III Trials In India

The Drugs Controller General of India (DCGI) has granted authorization for the conducting of the Phase III bridging trials of the Sputnik Light vaccine on the Indian population. The Sputnik Light is a single-dose Covid-19 vaccine of the Russian vaccine Sputnik.

After a study published in the medical journal, approval has been given. The study published in the Lancet said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines.

In July the, Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country. It was noted by the committee that the Sputnik Light was the same as component-1 of Sputnik V and its safety and immunogenicity data in the Indian population was already produced in a trial.

On at least 40,000 elderly people in Argentina, this study was conducted. Sputnik Light also reduced hospitalizations among the target population at 82.1-87.6 per cent.

Last year the Russian Direct Investment Fund (RDIF) partnered with Dr Reddy’s Laboratories to conduct the phase III trials of the Sputnik V vaccine in India. In April, Sputnik V received an emergency use authorisation in India. The first dose of the vaccine in Hyderabad under a limited pilot on May 14 was administered by Reddy’s.

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