RDIF seeks Indian regulatory nod for Sputnik M registration

New Delhi: The Russian Direct Investment Fund (RDIF) said on Monday that it has provided documents to India's regulator for the registration of Sputnik M, the vaccine for adolescents aged 12-17.

"RDIF has provided India's regulator with documents for registration of Sputnik M - the vaccine for adolescents aged 12-17. Russia's Health Ministry registered Sputnik M on November 24. It has become a new member of the Sputnik vaccines family and is offered to international markets, joining Sputnik V and Sputnik Light," the RDIF said in a statement.

"Subject to the positive decision of India's authorities, Sputnik M could become the first registered vaccine for adolescents in the country and make an important contribution in protecting the younger population," the statement added.

The Sputnik V vaccine is already being used in India after it received emergency use authorisation in April 2021. Sputnik V is the first foreign-made vaccine to be used in India.

The RDIF is also working with India's regulatory authorities for the registration of Sputnik Light, the one shot vaccine based on human adenovirus serotype 26, as a standalone vaccine and a universal booster.

Partnering Dr. Reddy's Laboratories, RDIF has conducted additional clinical trials of Sputnik Light in India. The data from these trials have been presented to the Drugs Controller General of India (DCGI).

Kirill Dmitriev, the CEO of RDIF, said, "Russia and India joined forces since the beginning of the pandemic. A number of agreements with partners in India have helped RDIF significantly increase its production capabilities. We are ready to offer the Sputnik Light vaccine and the Sputnik M vaccine for adolescents to support strong herd immunity in India and continue saving millions of lives."

The RDIF has expressed hope that Sputnik Light could be successfully applied as a booster dose in partnership with the Serum Institute of India, which already produces the two vaccines.

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