Dr Reddy’s completes Sputnik vaccine Phase-3 trials

G Naga Sridhar Hyderabad | Updated on March 15, 2021

The vaccine’s efficacy ‘is confirmed at 91.4% based on data analysis of the final control point of clinical trials in Russia’   -  Dado Ruvic

Result will be out in April; may be India’s third Covid vaccine option

Pharma major Dr Reddy’s Laboratories Ltd has completed Phase-3 trials of Russian Covid-19 vaccine Sputnik V.

The Phase-3 study of Sputnik V was conducted on about 1,500 subjects as 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 Covid vaccination has already commenced in public and private hospitals in the country with Serum Institute’s Covishield and Bharat Biotech’s Covaxin.

The outcome of Sputnik V’s trials are awaited by different stakeholders. “The data/results of Phase-3 trials will be available in early April,” Dr Reddy’s said.

Emergency use

The company had already applied for Emergency Use Authorisation of its vaccine but was asked to submit data on efficacy and other aspects as found in Phase-3 trials.

Once the data are ready next month, they will be submitted to the government for approval. If the efficacy is high and Sputnik V gets the nod, it is likely to be the third Covid vaccine that will be used in the country.

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

Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, Sputnik V was the world’s first registered vaccine against Covid based on the established human adenoviral vector platform.

91.6% efficacy

According to the company, “Sputnik V is one of the three vaccines in the world with an efficacy of 91.6 per cent and has most authorisations granted with 26 countries globally. The vaccine 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.

‘Adequate’ production agreements are already in place for production of Sputnik V in India with a few manufacturers, including Hetero, to facilitate its speedy roll out.

Published on March 15, 2021

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