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Sputnik Light receives emergency use approval from DCGI

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eMediNexus    07 February 2022

The Drugs Controller General of India has given emergency use approval to single-dose Sputnik Light COVID-19 vaccine, stated Union Health Minister Mansukh Mandaviya.

An expert panel of India’s central drug authority had recommended granting restricted emergency use authorization to Sputnik Light under certain regulatory provisions. Sputnik Light has become the ninth COVID-19 vaccine to be approved in the country.

Dr Reddy’s Laboratories had submitted its proposal seeking permission to import Sputnik Light for restricted emergency use as well as booster dose vaccination, with safety and efficacy data, including its benefit against the Omicron variant. The Subject Expert Committee (SEC) on COVID-19 of the CDSCO deliberated on the application by the company and noted that the safety and immunogenicity data presented from the Indian study was comparable to the ongoing Phase-3 trial interim data from Russia. The interim efficacy trial data from Russia indicates a 65.4% efficacy after 21 days of vaccination… (The Hindu – PTI, February 6, 2022)

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