Expert panel asks DRL to come back with more data on Sputnik safety

DRL applied for restricted emergency use of Sputnik V last week, has lined up 250 mn doses for Indians over next 12 months

The expert panel advising the Indian drug regulator has asked Dr Reddy's Laboratories (DRL) to come back with more data on safety and immunogenicity from their phase-2 and 3 studies on the Russian Sputnik V vaccine. 

The expert panel deliberated on the application made by DRL on Wednesday and felt that more data is required before a recommendation for approval can be granted, informed sources. "We have asked the firm to present more data on safety and immunogenicity from their phase 2 and 3 studies here," said one source in the know. The phase-3 studies ended here on February 21.