Sputnik M applies to Indian regulator for approval of vaccine for adolescents

“Subject to positive decision of India's authorities, Sputnik M could become the first registered vaccine for adolescents in the country,” RDIF said.
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Russian Direct Investment Fund (RDIF) on Monday said it has applied for the registration of Sputnik M, COVID-19 vaccine for adolescents aged 12-17, to the Indian regulator for approval. The sovereign wealth fund said Russia's Health Ministry registered Sputnik M on November 24, 2021. It has become a new member of the Sputnik COVID-19 vaccines family and is offered to international markets joining Sputnik V and Sputnik Light.

"Subject to 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," RDIF said in a statement.

Commenting on the development, RDIF CEO Kirill Dmitriev said, "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."

Stating that it is ready to provide the one-shot Sputnik Light vaccine and Sputnik M vaccine (for adolescents) as it develops strategic cooperation with partners in India to fight COVID, RDIF said Sputnik Light and AstraZeneca's Covishield could also be "successfully applied as a booster in partnership with Serum Institute of India, which already produces the two vaccines".

"Interim results of the study in Argentina on heterologous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino have shown Sputnik Light is an effective universal booster for these vaccines," RDIF said.

Results of a separate joint clinical trial of a combination of Sputnik Light with the AstraZeneca vaccine have demonstrated that it induces strong immunity and has a high safety profile, it added.

RDIF said has already reached agreements with leading Indian pharmaceutical companies, including Serum Institute of India, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen for production of its COVID-19 vaccines.

"Today India is the leading production hub for Sputnik V and Sputnik Light vaccines," it said, adding it is actively cooperating with India's regulatory authorities on registration of Sputnik Light as a standalone vaccine and a universal booster and "expects it to be authorised in the country soon".

The fund's partner Dr Reddy's Laboratories has conducted additional clinical trials of Sputnik Light in India. Positive data from these trials has also been presented to the Indian regulator, it added.

The Drugs Controller General of India (DCGI) had in September given permission to Dr Reddy's Laboratory Ltd to conduct phase-3 bridging trials of Sputnik Light in India.

In April 2021, India had granted an emergency use authorisation for Sputnik V. RDIF said its Sputnik V has been authorised in 71 countries with a total population of over 4 billion people.

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