The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has asked Dr Reddy’s Laboratories to present the safety, immunogenicity and efficacy data of the Phase-III clinical trials of the single dose Covid-19 vaccine, Sputnik Light, being carried out in Russia.
The SEC was responding to an application submitted by Hyderabad-based Dr Reddy’s Laboratories Ltd for granting marketing authorisation for Sputnik Light.
The vaccine is the first component of the double-dose Sputnik V, which is being administered in India alongside Covishield and Covaxin. It is based on the human adenovirus, which transmits genetic information of the novel coronavirus.
While denying a separate clinical trial for Sputnik Light as “there seems to be inadequate data and justification’’, the SEC observed that the immunogenicity data in the Indian population has already been generated.
Sputnik Light, developed by Gamaleya National Research Centre of Epidemiology and Microbiology, received authorisation for use in Russia in May.
Dr Reddy’s, which is the brand custodian of Sputnik V in India, as part of its collaboration with Russian Direct Investment Fund (RDIF), is now working on introducing the single-dose vaccine in India.
According to RDIF, data collected from 28 days after the shot showed that Sputnik Light has 79.4 per cent efficacy compared to 91.6 per cent for the two-dose Sputnik V.
The single-dose vaccine is seen by some experts as ‘suitable’ for India, given the task of vaccinating a large population and the shortage of vaccines.