InvestorQ : Has Reddy Labs secured approval for Phase 3 trials of Sputnik vaccine?
Anamika Sodhani made post

Has Reddy Labs secured approval for Phase 3 trials of Sputnik vaccine?

Angel dcosta answered.
2 years ago

Reddy Labs secured approval from the Drugs Control General of India or DCGI to conduct Phase-3 clinical trials for the Russia-based Sputnik-V vaccine as an antidote for COVID-19. Reddy Labs will conduct the Phase-3 analysis of Sputnik V on 1500 subjects as part of the randomized placebo-controlled study in India to get final approval for launch.

After reviewing the safety data from the Phase-2 clinical trials of the vaccine, the DSMB had recommended Phase-3 recruitment. The DSMB concluded that no safety concerns were observed in Phase-2 making Sputnik-V eligible to transmigrate to the third clinical phase. Reddy Labs will commence Phase-3 study during Jan-21 itself to test vaccine efficacy.

Reddy Labs, it may be recollected, had partnered with Russian Direct Investment Fund of Russia to conduct clinical trials of the Sputnik-V vaccine as well as for its distribution rights in India. Sputnik has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in Russia.

As of now, the efficacy of the vaccine has been confirmed at 91.4% based on data analysis of clinical trials conducted in Russia. Apart from India, the vaccine’s clinical trials are currently underway in the United Arab Emirates, Egypt, Venezuela and Belarus. If Reddy Labs can manage at a lower cost, it would be a great achievement.