Russia's Sputnik V gets approval for human trials in India: Report
Moscow : The coronavirus vaccine Sputnik V, which is being prepared by Russia, has been allowed to conduct human trials in India, the sovereign wealth fund said on Saturday.
The large-scale trials were announced earlier in India but were knocked down by Indian regulators, saying that sample size of Phase I and Phase II were very small, based on which the third phase trials cannot be allowed in the nation.
Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday.
Under the deal, Dr Reddy's will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr Reddy's.
Russia is the first country which has given regulatory approval for a novel coronavirus vaccine. The clinical trials of Sputnik V are also being carried out in Belarus, Venezuela and the United Arab Emirates. A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.
Interim results are likely to be delivered in November.