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. The firm presented safety profile from phase-2 clinical study and interim data from the phase 3 study. 

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

DRL partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine underwent a bridge trial in Indian on 1600 people. 

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase-3 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, DRL claimed. 

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. 

DRL would market the vaccine in India. It said it hopes to supply both to the government and also to the private market.On the pricing front, DRL has said it was discussing the Indian situation with RDIF. In India, vaccine makers like Serum Institute of India have announced two separate pricings — one for the government and the other for the private market. RDIF has announced a global price of $10 per dose for the Sputnik V earlier.