After rejecting the first proposal, India’s General Drug Controller finally allowed Dr. Reddy’s to conduct a phase 2/3 human clinical trial of Sputnik V, the Covid-19 vaccine that makes Russia the first country in develop a vaccine.
“This will be a multicentre, randomized controlled study, including a safety and immunogenicity study,” said a joint statement issued by Dr. Reddy’s and the Russian Direct Investment Fund (RDIF).
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Given that Sputnik V was tested on a small number of people in Russia before it was registered as a vaccine, the DCGI raised questions about Dr. Reddy’s initial proposal to test it on a larger population in India. Sputnik V is currently in a post-registration 3 clinical trial phase with 40,000 participants.
In September, 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, India will receive 100 million doses of Sputnik.
“We recognize DCGI’s scientific rigor and guidance throughout the entire process. 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, ”said GV Prasad, Co-President and Managing Director of Dr Reddy’s Laboratories.
Also read: Russia says its third Covid-19 vaccine is ‘almost ready’
On August 11, 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.
A second vaccine, EpiVacCorona, has been registered in Russia. The third vaccine has received permission to conduct the first and second stage of clinical trials at medical facilities in Novosibirsk, St. Petersburg and Kirov. During the first stage, 15 volunteers were inoculated with this vaccine on October 6.
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