India to conduct trials of Russia's Covid-19 vaccine Sputnik V

India’s drug regulator has given approval to the Sputnik V vaccine for a large-scale clinical trial to test the Russian origin vaccine’s ability to generate a protective immune response against Covid-19 among the recipients.

Russian Direct Investment Fund (RDIF), which funded the vaccine development and its Indian partner Dr Reddy’s Laboratories Ltd (DRL) on Saturday announced that they had received approval from the Drug Control General of India to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine in India.

This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study.

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Ten days ago, the DCGI had rejected a proposal for a direct phase-3 trial of Sputnik-V on the grounds that sample size was too small for the phase-I/II studies carried out abroad. Subsequently, the promoters modified their proposal and presented a plan for an integrated phase-2/3 trial of the vaccine before the DCGI.

Sputnik V is currently undergoing phase 3 clinical trial in Russia in which the researchers aim to involve 40,000 individuals to check how the vaccine works on a large scale. Additionally, a phase 3 clinical trial of the vaccine commenced in the UAE last week.

Last month, DRL and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India, depending on the outcome of the trial. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to DRL upon regulatory approval. In August, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vectors platform.

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However, there are many sceptics, who question the lack of adequate clinical trial data to judge the quality and efficacy of the vaccine. Results from the early-phase trials of Sputnik V in a total of 76 people - published in Lancet last month – demonstrated that two formulations of the two-part vaccine exhibited a good safety profile with no serious adverse events detected over 42 days, and induce antibody responses in all participants within 21 days.

Three other vaccines – including two home-made ones – are undergoing various phases of clinical trials in India. The progress was reviewed on Saturday in a high-level meeting chaired by Prime Minister Narendra Modi.