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MOSCOW (Reuters) – The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Ltd have received renewed approval to conduct late-stage clinical trials of the Russian COVID-19 vaccine in India, the sovereign wealth fund said on Saturday.
The large-scale trials of the Sputnik V vaccine in India were first announced and later rejected by Indian regulators, who said the scale of the phase I and II trials conducted in Russia earlier this year was too small, and requested that they be repeated.
Following a new agreement, India will now conduct a phase II and III adaptive human clinical trial with 1,500 participants, RDIF, which markets the vaccine overseas, said on Saturday. Under the agreement, 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, the first country to grant regulatory approval for a new coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates. RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the injection.
A phase III trial with 40,000 participants is currently underway in Moscow, and 16,000 people have already received the first dose of the two-shot vaccine.
Interim results are expected to be released in early November.
Indian regulators agreed to incorporate data, provided by Russia weekly, from the Moscow trial, a source close to the deal told Reuters.
Russia has also reached an agreement with the biotechnology department of the Indian Ministry of Science and Technology to use its laboratories as the basis for the Indian clinical trial, the source said.
(Reporting by Polina Ivanova; written by Polina Ivanova and Maxim Rodionov; edited by Kirsten Donovan)
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