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Wednesday, September 22, 2021

Sputnik’s single-dose vaccine gets DCGI nod for Phase-III trials in India – ET HealthWorld

Sputnik's single-dose vaccine gets DCGI nod for Phase-III trials in IndiaNEW DELHI: The Drugs Controller General of India (DCGI) has granted permission for the conducting of the Phase III bridging trials of Sputnik Light on the Indian inhabitants. The Sputnik Light is a single-dose Covid-19 vaccine of the Russian vaccine Sputnik.

The nod comes after a latest research printed in the medical journal The Lancet mentioned that Sputnik Light confirmed 78.6 to 83.7 per cent efficacy in opposition to Covid-19, considerably larger than most two-shot vaccines.

The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) in July had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the necessity for the conduct of the part III trial of the Russian vaccine in the nation.

The committee had famous that Sputnik Light was the identical as part-1 of Sputnik V and its security and immunogenicity knowledge in the Indian inhabitants was already generated in a trial.

The research was carried out on no less than 40,000 aged folks in Argentina. Sputnik Light additionally diminished hospitalizations among the many goal inhabitants at 82.1-87.6 per cent, the research mentioned.

The Russian Direct Investment Fund (RDIF) final 12 months partnered with Dr Reddy’s Laboratories to conduct the part III trials of Sputnik V vaccine in India. In April, Sputnik V acquired an emergency use authorisation in India. Reddy’s administered the primary dose of the vaccine in Hyderabad below a restricted pilot on May 14.

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