Single-dose Sputnik Light Covid-19 vaccine gets EUA in India

India’s drug regulator on Sunday granted emergency use authorisation (EUA) to Single-dose Sputnik Light Covid-19 vaccine in India.

With this, Sputnik light becomes the ninth Covid-19 vaccine that has been granted EUA in the country.

“This will further strengthen the nation’s collective fight against the pandemic,” tweeted Union health minister Mansukh Mandaviya.

Dr Reddy’s had completed Phase-3 clinical trial data of Sputnik Light and sought approval from DCGI to use the vaccine as standalone in January this year.

Around 6.5 lakh people have already taken the first dose of Sputnik V first dose.

“We feel confident that Sputnik Light is not only effective against other variants of concern, but also with Omicron,” MV Ramana, CEO, Branded Markets (India and Emerging Markets) of Dr. Reddy’s said during the post earnings media briefing last month.

Sputnik V is a two-dose vaccine made from two components – recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5 The first dose (Ad26) is the main vaccine, and the second (Ad5) is a booster shot. The Sputnik Light vaccine is made from Ad26, which is the first part of the Sputnik V vaccine.

The company has also submitted a proposal to conduct clinical trials to test Sputnik Light as a booster to other vaccines.

Russia’s Gamelya Center had in December last year said that the Sputnik Light booster dose increased virus neutralizing activity against Omicron. The data was based on sera 2-3 months after re-vaccination.

Earlier on February 4, the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announced that Sputnik V was granted full permanent approval by Russia’s Health Ministry. It had previously held temporary emergency use authorization (EUA) from the Russian regulator.

Sputnik Light is authorized in over 30 countries, both as a standalone vaccine and a universal booster to other vaccines.

Dr Reddy’s is also trying to bring Sputnik M vaccine for adolescents to India. Sputnik M has been approved in Russia for children and adolescents of age 12-18.

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