Expert panel seeks more data on Sputnik V from Dr Reddy’s

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

The panel deliberated on the application made by DRL on Wednesday, and felt more data was required before a recommendation for approval could be granted, said people in the know.

“We have asked the firm to present more data on safety and immunogenicity from their phase 2 and 3 studies here,” said one of them. The phase-3 studies ended on February 21. The firm presented safety profile from its phase2 clinical study and interim data from phase-3.

DRL had applied for restricted emergency use authorisation of Sputnik V last week. It has lined up 250 million doses for Indian citizens (from manufacturing partners) over the next 12 months.

DRL partnered the Russian Direct Investment Fund (RDIF) to conduct clinical trials, and for distribution rights in India. The vaccine underwent a bridge trial in India on 1,600 people.

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase-3 clinical trial, which included data on 19,866 volunteers in Russia who received both the first and second doses of the vaccine.

Sputnik V maintained an efficacy at 91.8 per cent, even among the group of 2,144 volunteers over 60 years old, according to DRL.

The human adenoviral vector (flu virus) based vaccine candidate is developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in Russia and was registered in that country in August last year.