The trials commenced after obtaining the necessary clearance from the Central Drugs Laboratory. Credit: fernando zhiminaicela from Pixabay.

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) have initiated adaptive Phase II/III clinical trials for Sputnik V vaccine in India.

Sputnik V is the first registered vaccine against Covid-19 created on a human adenoviral vector platform.

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The trials commenced after obtaining the necessary clearance from the country’s Central Drugs Laboratory.

The multi-centre and randomised controlled study will analyse the safety and immunogenicity of the vaccine.

Clinical research partner JSS Medical Research is conducting the trials.

Moreover, Dr Reddy’s has collaborated with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use the latter’s clinical trial centres for the vaccine.

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According to the recent second interim analysis of trial data, the vaccine demonstrated 91.4% efficacy on day 28 after the first dose and vaccine efficacy was over 95% 42 days after the first dose.

At present, 40,000 participants are enrolled in the Phase III trial of Sputnik V vaccine.

Over 22,000 of them have been given the first dose of the vaccine and over 19,000 received the first and second dose of the vaccine.

Dr Reddy’s Laboratories co-chairman and MD G V Prasad said: “This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India.

“We are working towards making the vaccine available with a combination of import and indigenous production model.”

Dr Reddy’s and RDIF signed a deal in September for clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.

In November, the RDIF and Gamaleya Center announced that a first interim analysis of Phase III trials of the Sputnik V vaccine demonstrated 92% efficacy in Covid-19 patients.