The phase 2/3 trial will be a multicenter, randomized controlled study, which will include a safety and immunogenicity study, Dr. Reddy’s and RDIF said without disclosing further details. The approval was granted by the committee of experts in the field (SEC), which advises the drug regulator on both clinical trials and drug and vaccine approvals, at its meeting on Friday.
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Dr. Reddy’s Co-Chairman and Managing Director GV Prasad called it a significant advance that will allow the company to begin clinical trials of Sputnik V in India. “We are committed to bringing a safe and effective vaccine to fight the pandemic,” he said.
RDIF Executive Director Kirill Dmitrev said that in addition to the data from the Indian clinical trials, RDIF will also provide a safety and immunogenicity study from the Russian phase 3 clinical trial. “These data will further strengthen the clinical development of the vaccine. Sputnik V in India, “he said.
At its meeting on October 5, 2020, the SEC had rejected the protocol submitted by Dr. Reddy’s to immediately conduct phase III trials of the Russian vaccine in India, stating that safety and immunogenicity data in phase trials Sputnik V’s I / II overseas were too small and there was no data available on Indian subjects.
“After detailed deliberation, the committee recommended that the company should follow regulatory requirements and conduct a phase II / III clinical trial in the country with adequate monitoring of the humoral and cell-mediated immune response,” the committee told ask Dr. Reddy to submit a proposed revision to the protocol for conducting Phase II and III studies.
While Sputnik V is currently in phase 3 clinical trials with 40,000 volunteers in Russia, a phase 3 clinical trial of the vaccine also began last week in the United Arab Emirates.
While scientists had raised questions about the safety and efficacy of SputnIk V when Russian President Vladimir Putin announced its development to the world without their data being released and without large-scale trials being conducted, however, the subsequent medical journal Lancet had said that two trials of the vaccine in June and July, involving 76 participants showed that all participants developed antibodies against the new coronavirus without serious side effects.
RDIF had signed an agreement with the Hyderabad-based pharmaceutical giant in September this year to carry out phase 3 clinical trials of Sputnik V in India and distribute 100 million doses of the vaccine in the Indian market after regulatory approvals. .
Sputnik V, which has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and RDIF, became the first Covid-19 vaccine registered in the world based on the human adenoviral vector platform on August 11, 2020. The vaccine uses two adenovirus vectors (rAd26 and rAd5) against the SARS-CoV-2 virus.
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