Sputnik Light vaccine likely to be authorised in India soon: RDIF

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, said it has also provided India’s regulator with documents for registering Sputnik M, a variant of the vaccine for adolescents aged 12-17
The Sputnik V vaccine is already used in India following the grant of emergency use authorisation in April this year. (REUTERS)
The Sputnik V vaccine is already used in India following the grant of emergency use authorisation in April this year. (REUTERS)
Updated on Dec 07, 2021 07:20 AM IST
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The backer of Russia’s Sputnik Light single shot Covid-19 vaccine said on Monday it has presented data from additional clinical trials to India’s regulator and expects the jab to be authorised in the country soon.

The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, said it has also provided India’s regulator with documents for registering Sputnik M, a variant of the vaccine for adolescents aged 12-17.

RDIF said these moves were part of efforts to expand cooperation between India and Russia in the fight against Covid-19. The Sputnik V vaccine is already used in India following the grant of emergency use authorisation in April this year.

Russian foreign minister Sergey Lavrov said during a media interaction in New Delhi that talks on the production of Sputnik Light in India were nearing completion, though he didn’t give details.

Asked about plans to begin production of Sputnik Light in India in December, Lavrov said: “The talks on Sputnik Light are about to be completed and Sputnik V is already being produced in India. We are talking about several hundred million doses per year.”

There was no word from the Indian side on the matter.

RDIF said in a statement: “Currently, RDIF is actively cooperating with India’s regulatory authorities on registration of Sputnik Light (the one-shot vaccine based on human adenovirus serotype 26, the first component of the Sputnik V) as a standalone vaccine and a universal booster and expects it to be authorised in the country soon.”

RDIF’s partner, Hyderabad-based Dr Reddy’s Laboratories, has conducted additional clinical trials of Sputnik Light in India and “positive data” from these trials has been presented to India’s regulator, the statement added.

The fund has also provided India’s regulator with documents for registering Sputnik M, which was registered by Russia’s health ministry on November 24. It is a new member of the Sputnik vaccines family and is currently being offered to international markets.

The statement said that subject to a “positive decision of India’s authorities, Sputnik M could become the first foreign registered vaccine for adolescents in the country”.

RDIF CEO Kirill Dmitriev said: “Russia and India have joined forces since the beginning of the pandemic, with this strategic partnership including production of Sputnik V and Sputnik Light vaccines. A number of agreements with partners in India have helped RDIF to significantly increase our 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,” Dmitriev added.

Sputnik V has been authorised in 71 countries with a total population of over four billion people. RDIF has reached agreements with leading pharmaceutical companies, including Serum Institute of India, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen, to produce the Russian vaccines and India is now the leading production hub for Sputnik V and Sputnik Light.

The latest findings by the Gamaleya Center, the developer of the Sputnik vaccines, which are based on data from 28,000 subjects in Moscow, have shown that Sputnik Light administered standalone has 70% efficacy against infection from the Delta variant of the Coronavirus during the first three months after vaccination.

The vaccine is 75% effective among subjects under the age of 60. Efficacy of Sputnik Light as a booster against Delta variant for other vaccines will be close to the efficacy against the Delta variant of the Sputnik V vaccine – more than 83% against infection and more than 94% against hospitalisation.

Interim results of a study in Argentina on combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino have shown Sputnik Light is an “effective universal booster”, the statement said.

Results of a separate joint clinical trial of a combination of Sputnik Light with the AstraZeneca jab have demonstrated it “induces strong immunity and has a high safety profile”.

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Saturday, May 28, 2022