An expert panel of the country’s central drug authority has asked for additional information from Dr Reddys Laboratories, which applied for emergency use authorization for the Russian COVID-19 vaccine, Sputnik V. The decision on the authorization was deferred till the next meeting.

The company had submitted the interim safety and immunogenicity data of the Gam-Covid-Vac combined vector vaccine from the county, in addition to the interim data from the ongoing Russian study. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) has recommended that the company must submit data regarding all immunogenicity parameters, unblinded data of serious adverse events and RT-PCR positive cases, and the causality analysis reported till now, for further evaluation… (ET Healthworld – PTI, April 2, 2021)