Russia shares ‘safety,’ ‘efficacy’ data on Sputnik V with India, Phase 3 trials may follow

Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology has submitted “comprehensive data” on the safety and efficacy of Russian COVID-19 vaccine candidate Sputnik V, to Indian authorities, the Indian Express reported.

Sputnik V has cleared Phase 1 and 2 of its human clinical trials and had reportedly triggered a “strong” immune response among 76 people.

The report said that India, which had sought details of the vaccine from Russia is “deeply engaged” with the Eurasian country in developing the vaccine with the process being coordinated by Renu Swarup, secretary, department, and Biotechnology and Indian Ambassador to Russia DB Venkatesh Varma.

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Once the data received from the Russian institute is assessed, there could be a separate Phase 3 clinical trials in India with due approval from the drug regulator.

Russia has said that 20 countries including UAE, Saudi Arabia, Indonesia, India, the Philippines, Brazil and Mexico had “expressed interest in obtaining the Sputnik V” and that Phase 3 clinical trials will be conducted in many of these countries.

According to the Lancet study, the Phase 3 trials of the vaccine will involve 40,000 volunteers who would be constantly monitored through an online application with ease dose administered to a volunteer having its own QR code.

Researchers in the first and second phase of trials – each conducted on 38 healthy individuals aged between 18 and 60 – found the vaccine to be “safe, well-tolerated and does not cause serious adverse events in healthy adult volunteers”.

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Reports say that a batch of the vaccine could be cleared for civilian use in Russia this week.