Sputnik V applies for Phase III clinical trials in India: Report

“The DSMB has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continuation of the clinical trial without any modifications,” Dr Reddy’s said.

Moneycontrol News
January 12, 2021 / 08:19 AM IST

India may have another vaccine against COVID-19 in its arsenal as Russia's Sputnik V has applied for the Drugs Controller General's (DCGI) nod for stage III clinical trials in India, News18 reported.

"Vaccine is meeting safety endpoint," the company said.

This comes after Dr Reddy's Laboratories on January 11 said that Phase III trials for the vaccine candidate has been recommended by the Data and Safety Monitoring Board (DSMB).

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“The DSMB has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continuation of the clinical trial without any modifications,” Dr Reddy’s said.

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Dr Reddy’s had partnered with the Russian Direct Investment Fund (RDIF) in September 2020, to conduct clinical trials of Sputnik V in India and for its distribution rights in the country.

A DSMB is a group of individuals, appointed by the sponsors, which conducts regular reviews of ongoing clinical trials based on accumulating data.

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GV Prasad, CMD of Dr Reddy’s said, “Phase II trials showed a very good safety profile for Sputnik V, which has been administered for more than 1 million people in Russia and 300,000 people in Argentina. We are now working closely towards fast-tracking the launch of the Sputnik V vaccine in India.”

Phase II was a randomised, double-blind, parallel-group, placebo-controlled study of 100 subjects in India. Safety data from the same has been submitted to the DCGI for review and approval of Phase III, the report said.

Sputnik V is among the top 10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organisation's list. Russia says its efficacy is confirmed at 91.4 percent. Clinical trials for it are currently ongoing in Algeria, Argentina, Belarus, Bolivia, Egypt, Serbia, Venezuela, and the UAE.

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TAGS: #coronavirus #Dr Reddys #Health #India #sputnik v #vaccine
first published: Jan 12, 2021 08:19 am