Union Health Minister Mansukh Mandaviya announced on Sunday that the Drugs Controller General of India (DCGI) has granted restricted emergency use authorisation to the single-dose Sputnik Light COVID-19 vaccine.
This makes it the ninth vaccine to receive approval in the country against the infection.
The minister wrote on Twitter, “DCGI has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India.
This is the 9th #COVID19 vaccine in the country.
This will further strengthen the nation’s collective fight against the pandemic.”
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Sputnik Light is an adenovirus vector platform vaccine developed by Russia’s Gamaleya Center. It is identical to component-1 of the Russian Sputnik V vaccine that has been used in India’s vaccination drive, along with Covishield and Covaxin.
The approval comes after Dr Reddy’s Laboratories said it had submitted a proposal to the DCGI to register Sputnik Light vaccine as a booster dose against the infection. The firm said the vaccine candidate is approved in 29 countries.
The drug major had earlier partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and distribute the vaccine in India in September 2020.
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Last year, Dr Reddy’s had received permission from the DCGI to import the Sputnik vaccine into India for restricted use in emergency situations in April.
“As regards to Sputnik, we are now ready with capacities in India. We are working actively with the Government of India for registering Sputnik Light as a vaccine and as a booster dose of Sputnik V,” Dr Reddy’s Laboratories CEO Erez Israeli said in an analyst call, reported news agency PTI.
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The recommendation for granting restricted emergency use authorisation to the Russian vaccine was put forward by a subject expert panel on Friday, according to sources quoted in various reports.
“A preliminary study of the Gamaleya Center has found Sputnik Light significantly increases virus-neutralizing activity against Omicron based on sera 2-3 months after revaccination with 100% of individuals revaccinated with Sputnik Light as a booster having developed neutralizing antibodies against this variant,” the Russian Direct Investment Fund had said earlier, according to The Indian Express.