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A new member of the Sputnik family of Covid-19 vaccines, Sputnik M, for adolescents, is up for registration with the Indian drug regulator, according to the Russian Direct Investment Fund (RDIF).
The documents for registration of Sputnik M, for those in the 12-17 age group, have been provided to the drug regulator, said the RDIF, adding its vaccine to the basket of vaccines for adolescents in India.
Sputnik Light
Russia’s sovereign wealth fund RDIF and the Gamaleya Institute’s Sputnik V (a two-dose vaccine) is already available in India. It’s single-dose Sputnik Light expects to get the Drugs Controller General of India’s nod as a standalone vaccine and universal booster, said the RDIF.
Sputnik M was registered by Russia’s Health Ministry 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,” said the RDIF.
Kirill Dmitriev, RDIF Chief Executive, said: “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.”
RDIF partners with Dr Reddy’s Laboratories to bring the Sputnik family into the country, even as it has multiple production alliances with other Indian vaccine-makers, including Serum Institute of India, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech and Morepen.
According to the RDIF, the single-dose Sputnik Light has 70 per cent efficacy against infection from the Delta variant of Covid during the first three months after inoculation. The vaccine is 75 per cent effective among subjects under the age of 60, the note said.
Children’s vaccines
At present, five Covid vaccines for adolescents and children are in different stages of regulatory approval or trial. They include Zydus Cadila’s ZyCoV-D, Bharat Biotech’s Covaxin, Serum Institute’s Covovax (from the company Novavax), Biological E’s RBD, and Johnson & Johnson’s Ad 26COV.2S vaccine.
The Minister of State for Health and Family Welfare, Dr Bharati Pravin Pawar, on Tuesday, said in a reply to the Rajya Sabha that Bharat Biotech is conducting Phase II/III clinical trial of Covaxin on healthy volunteers aged 2 to 18 years, and the company has submitted interim safety and immunogenicity data to the national regulator. Serum Institute is conducting Phase II/III clinical trials of Nanoparticle Vaccine (liquid) (Covovax) in 920 subjects in the age group of 2-17.
Further, Biological E is conducting Phase II/III clinical trial of RBD of SARS-CoV-2 gene in 624 subjects of 5-18 years age group. Also, Johnson & Johnson is conducting Phase II/III clinical trial of Ad.26 COV.2S vaccine in the age group of 12-17 years.
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