New Delhi: Dr. Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, announced on Saturday that they received approval from the Drug Control General of India (DCGI) to conduct late-stage clinical trials for the Sputnik V vaccine. in India. . This will be a multicenter, randomized controlled study, which will include a safety and immunogenicity study.
In early September 2020, Dr. Reddy’s and RDIF partnered to conduct clinical trials of the Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF will supply 100 million doses of the vaccine to Dr. Reddy’s following regulatory approval in India.
Dr. Reddy’s and RDIF initially planned to conduct only one phase 3 trial of the vaccine, but the subject matter expert committee (SEC) of the Central Drug Standards Control Organization (CDSCO) asked Dr. Reddy’s to conduct a non-stop Phase 2 and 3 clinical trial in India, rather than just a Phase 3 study, because safety and immunogenicity data in phase I / II studies abroad were small and no data was available on Indian subjects.
Following a new agreement, India will now carry out a phase II and III adaptive human clinical trial with 1,500 participants, RDIF, which markets the vaccine overseas, said on Saturday, Reuters reported.
GV Prasad, Co-President and Managing Director of Dr. Reddy’s Laboratories, said: “This is a significant advance that allows us to begin the clinical trial in India and we are committed to bringing a safe and effective vaccine to combat the pandemic.”
Kirill Dmitriev, Executive Director of the Russian Fund for Direct Investment, said: “We are pleased to collaborate with Indian regulators and, in addition to the data from the Indian clinical trials, we will provide a safety and immunogenicity study from the Russian phase 3 clinical trial. data will further strengthen the clinical development of Sputnik V vaccine in India. “
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.
On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health and became the world’s first registered vaccine against COVID-19 based on the platform of human adenoviral vectors.
Gamaleya had carried out a phase 1 and 2 phase in Russia of just 76 patients, in which the vaccine was shown to induce a strong immune response among participants. The study was published in The Lancet, a peer-reviewed journal, last month.
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. Additionally, the phase 3 clinical trial of the vaccine began in the UAE last week.
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.
With input from Reuters
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