Dr Reddy's applies for emergency use approval for Sputnik V vaccine

Aims to launch the vaccine in March if regulator approval comes through

Dr Reddy’s Laboratories (DRL) has applied for emergency use authorisation with the Indian drug regulator for Sputnik V vaccine. Earlier, DRL had indicated that it aimed to launch the vaccine in March itself if it gets the regulator's nod.
 
It has lined up 250 million doses of the vaccine for Indian citizens (from manufacturing partners) over the next 12 months.
 
The human adenoviral vector (flu virus)-based vaccine candidate is developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Russia and was registered in that country in August last year. DRL will present the safety profile of the phase 2 clinical study and the interim data of the phase 3 study which is expected to be completed by February 21, the company said.
 
The subject expert committee (SEC), which is advising the Drugs Controller General of India (DCGI), is likely to review the application next week. The vaccine has been granted authorisat­ion in 26 countries and has been already administered to more than 2 million people worldwide.
 
DRL partnered the Russian Direct Inves­tment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India. Currently, the vaccine is undergoing the phase 3 clinical trials in India. 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 2,144 volunteers over 60 years old, DRL claimed.

 
G V Prasad, co-chairman and managing director, DRL, said, “The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to Sputnik V vaccine in India.”
 
Meanwhile, DRL is in discussions with the RDIF to expand the scope of this partnership on Sputnik to other countries where Hydera­bad-based pharma major has strong presence.
 
Speaking to the media in a post-results conference, Deepak Sapra, chief executive officer (API and pharma business) of DRL, had said the company lined up supplies of 125 million patient doses (each patient needs two jabs) for Indians from its partners over the next 12 months. While most of these doses would come from Indian manufacturers, some would come from Russia. It is a two dose vaccine given 21 days apart.
 
The RDIF has two partners in India, including Hyderabad-based Hetero, to manufacture the vaccine in India. Currently, the process of technology transfer is on at the two sites. In November, Hetero had announced a pact to make 100 million doses of the Sputnik V per year in India.
 
DRL would market the vaccine in India. According to DRL, it hopes to supply both to the government and also to the private market.
 
On the pricing front, DRL 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 Sputnik V earlier.
 
Sapra said discussions on the India pricing were on.