Dr Reddy's labs begins Sputnik V Emergency Use Authorization process
Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2, 144 volunteers over 60 year old.;
Hyderabad: Drug major, Dr. Reddy's Laboratories Ltd., has recently announced that the company has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V.
As part of the review process, Dr. Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 2st February 2021.
In September 2020, Dr. Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the phase 3 clinical trial in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8% even among the group of 2, 144 volunteers over 60 years old.
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