The Drugs Controller General of India has granted emergency use permission to single-dose Sputnik Light COVID vaccine in the country, Union Health Minister Mansukh Mandaviya said on Sunday.
This comes following recommendations of an expert panel of India’s central drug authority to grant restricted emergency use authorisation to Sputnik Light subject to various regulatory provisions.
Sputnik-Light is the same as component-1 of Sputnik V.
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“DCGI has granted emergency use permission to single-dose Sputnik Light COVID-19 vaccine in India. This is the ninth COVID-19 vaccine in the country. This will further strengthen the nation’s collective fight against the pandemic,” Mr. Mandaviya tweeted.
An official source said in light of recommendations of Subject Expert Committee (SEC) following a meeting on January 31, Dr Reddy’s Laboratories presented its proposal for grant of permission to import Sputnik Light for restricted emergency use and booster dose vaccination along with analysis of safety and efficacy data including its benefit against Omicron.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
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“The SEC on COVID-19 of the CDSCO, which deliberated on the application by Dr Reddy’s Laboratories, noted the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing Phase-3 clinical trial interim data from Russia,” the source said.
The interim data of efficacy trial from Russia has shown 65.4 per cent efficacy, 21 days after immunization.
“After detailed deliberation, the SEC had recommended grant of permission for restricted use in emergency situation subject to various regulatory provisions including,” the source said.