After striking down the first proposal, the Drug controller General of India has finally allowed Dr Reddy’s to conduct phase 2/3 clinical human trial of Sputnik V, the Covid-19 vaccine that makes Russia the first country to have come up with a vaccine.
“This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study,” a joint statement issued by Dr Reddy’s and Russian Direct Investment Fund (RDIF) said.
Since Sputnik V was tested on a small number of people in Russia before it got registered as a vaccine, the DCGI raised questions over Dr Reddy’s initial proposal of testing it among a bigger population in India. At present, Sputnik V is currently undergoing post-registration phase 3 clinical trial engaging 40,000 participants.
In September, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, India will get 100 million doses of Sputnik.
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