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

INDIA – 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 population. The Sputnik Light is a single-dose Covid-19 vaccine of the Russian vaccine Sputnik.

The nod comes after a recent study published in the medical journal 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 authorization to Sputnik-Light, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country.

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.

This approval is subsequent to a study that was conducted on at least 40,000 elderly people in Argentina. Sputnik Light reduced hospitalizations 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.

Early this month, Dr Reddy’s Laboratories initiated supply of the first dose component of Russian coronavirus vaccine Sputnik V to partner hospitals all over India.

The development followed the announcement that Panacea Biotec supplied the first shipment of the second component of the Russian Sputnik V vaccine manufactured by it for sale in the country.

Dr Reddy’s earlier suspended the supply of the first dose of Sputnik V following supply constraints from Russian Direct Investment Fund.

The pharma giant advised that the Russian vaccine, which is administered in two doses with a 21-day gap, should be taken from the same hospital.

The city-based drug maker also launched a website to keep the public updated on the availability of the Sputnik V vaccine the site contains a list of cities, towns and hospitals where the vaccine is available.

Dr Reddy’s is in a pact with RDIF to sell the first 125 million people doses (250 million vials) of coronavirus vaccine Sputnik V in India.

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