Enrollment of volunteers for mid-stage human trials of the Russian Covid-19 vaccine Sputnik V is likely to begin in the next few days, said Dr Reddy’s CEO Erez Israeli. The firm, which will be conducting the testing here, expects to complete late-stage trials of the vaccine candidate by mid-May next year at the latest.
“As for the timing, we start in the next few days,” said Israeli during a virtual briefing following the firm’s Q2 earnings on Wednesday. The firm will be enrolling around 100 participants in the phase 2 trials. Once it receives approval it will be recruiting around 1,400 participants for the phase 3 trials.
“The phase 2, I hope, will be finished by December — not just the enrollment and the trials, but also compilations of the results and, hopefully, the relevant positive response from authorities that we can continue (with the trials),” he said. “Phase 3 should be finished somewhere around March…it can be as early as the end of March to April or May,” he said.
Any decision to grant emergency use approval for the vaccine here will be left up to the Indian regulator, according to him. “This will be a decision of the authorities…we hope we can bring the product as soon as possible,” he said.
While Sputnik V already received approval and was registered by the Russian Ministry of Health in August, Dr Reddy’s has not held any discussions on the pricing of the vaccine with the Indian government so far, said Israeli.
The Russian Direct Investment Fund (RDIF), Dr Reddy’s partner to supply the vaccine, is in talks with manufacturers to produce Sputnik V in India.
“The product will be produced in India with a partner,” he said.
Sputnik V uses ‘human adenoviral vector’ technology, using two different genetically modified adenoviruses to carry the spike protein. The vaccine containing the second adenovirus is given 21 days after the first one and is expected to “boost” the body’s immune response and build “long-lasting immunity”.
Dr Reddy’s received regulatory approval earlier this month to conduct phase 2/3 trials of the vaccine, which was developed by Moscow’s Gamaleya Research Institute. Once it receives regulatory approval here, RDIF will supply around 100 million doses of the vaccine to Dr Reddy’s for distribution. The vaccine is also undergoing phase 3 clinical trials in Russia with a proposed number of 40,000 subjects, as well as additional phase 3 trials in the UAE that commenced this month.
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