Pharma giant Dr. Reddy’s Laboratories Ltd 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.
“We have completed the dosing for Phase-3,” a spokesperson of Dr Reddy’s Laboratories Ltd told BusinessLine.
The completion of Phase-3 trials assumes significance 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, sources have told News18.
Reportedly, the manufacturing company had already applied for Emergency Use Authorisation of the vaccine but the authorities were asked to submit data on efficacy as found in Phase-3 trials. In April, as soon as the data will come it will be submitted to the government for approval. However, if the efficacy data is high, Sputnik V would get a nod.
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 based on the established human adenoviral vector platform. Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, the vaccine has an efficacy of 91.6 per cent and has most authorisations granted with 26 countries globally.
It has already been administered to more than two million people worldwide.
More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. However, Sputnik’s production agreements are already in place in India with a few manufacturers, including Hetero, to facilitate its speedy rollout.