Pharma giant Dr. Reddy’s Laboratories Ltd has completed Phase-3 trials of Russian Covid-19 vaccine Sputnik V. Conducted on 1,500 subjects, the phase-3 study of the vaccine was part of the randomised, double-blind, parallel-group, and placebo-controlled study in India.
The completion of Phase-3 trials is important as the Covid inoculation drive in collaboration with Serum Institute’s Covishield and Bharat Biotech’s Covaxin has already begun across the country.
The results of Sputnik V’s trials are awaited by different stakeholders and the data/results of Phase-3 trials will be available in early April. After a review, Sputnik will soon be added in India’s mass vaccination drive, say reports.
The company had already applied for Emergency Use Authorisation of the vaccine but the authorities were asked to submit data for Phase 3 trials.
In September 2020, Dr. Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the vaccine and for its distribution rights in India. Sputnik V was the world’s first registered vaccine against Covid-19.