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 sovereign wealth fund said on Saturday.
FILE PHOTO: Bottles with Russia's"Sputnik-V" vaccine against the coronavirus disease are seen before inoculation at a clinic in Tver, Russia October 12, 2020. REUTERS/Tatyana Makeyevahave received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine, the sovereign wealth fund said on Saturday.
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.
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.Indian regulators have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.
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