Indian Drug Regulator's Expert Panel Asks For More Data To Recommend Emergency Use Of Russian Sputnik V COVID-19 Vaccine

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation(CDSCO), India's drug regulator, has deferred its decision on whether to recommend the Russian Sputnik V Covid-19 vaccine for emergency use, reports Livemint.

Hyderabad based pharmaceutical major Dr Reddy's Laboratories which had applied for the EUA for Sputnik V has been asked to provide more data to the SEC before a decision can be taken on the EUA recommendation.

The SEC is said to have asked the pharmaceutical giant to provide the fact sheet for the vaccine along with details on stability, as a variant of the vaccine needs to be stored at a temperature of -18 degree Celsius.

It should be noted that Dr Reddy's has a pact with the vaccine's co-developer Russian Direct Investment Fund (RDIF) for carrying out the clinical trials, and to distribute the vaccine in the country subject to authorisation. The vaccine has claimed a high interim efficacy of 91.6 per cent.

Meanwhile, RDIF has also signed pacts with four other Indian companies for manufacturing a total of 750 million doses.