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The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Ltd have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine, the autonomous wealth fund said on Saturday.
Large-scale trials of the Sputnik V vaccine in India were announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year was too small, asking that they be repeated.
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 overseas, said on Saturday. Under the deal, Dr Reddy’s will run the clinical trials and, subject to approval, distribute the finished vaccine in India.
RDIF has reached agreements with Indian producers to produce 300 million doses of the shooter.
A Phase III trial involving 40,000 participants is now underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.
Interim results are expected to be published in early November.
Indian regulators have agreed to integrate information, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.
Russia has also reached an agreement with the biotechnology department of India’s Science and Technology Ministry to utilize its laboratories as a foundation for the Indian clinical trial, the source said.
