InvestorQ : What is the latest status on the Sputnik Vaccine and has Reddy Labs applied for approval for COVID inoculation?
Dawn Cherian made post

What is the latest status on the Sputnik Vaccine and has Reddy Labs applied for approval for COVID inoculation?

Mitali Bhutta answered.
2 years ago

Here is what you need to know about the vaccine candidate, Sputnik of Russia, and the progress along with its India partner Reddy Labs.

· Dr Reddy’s Laboratories has already applied to the concerned authorizing body for emergency use authorisation for Sputnik V vaccine. DRL had indicated that it aimed to launch the vaccine in March 2021, but that looks a tad tough now.

· Reddy Labs is the manufacturing partner for Sputnik and has already lined up 250 million doses of the vaccine for Indian citizens to be administered and implemented over the next 12 months’ time frame.

· Sputnik is a flu virus-based vaccine candidate and it has been developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Russia. As part of the process, DRL will present the safety profile of the phase 2 clinical study and interim data of the phase 3 study which will be through by February 21.

· In India, the Subject Expert Committee or SEC is tasked with advising the Drugs Controller General of India DCGI, about the merits and demerits of the vaccine candidate and help them interpret the outcome of the test results. The Sputnik-V vaccine has been authorised in 26 countries and administered to over 2 million people.

· Currently, the Sputnik-V vaccine is in the middle of phase-3 clinical trials in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of Phase-3 clinical trial. In this small sample testing, over 19,800 volunteers were tested and efficacy rate of 91.8% was maintained across both the doses.

· RDIF or Russia has partnered in India Hyderabad-based Hetero and with DRL. Currently, the process of technology transfer is on at the two sites. Hetero had announced plans to make 100 million doses of the Sputnik V per year in India. The deal is that Reddy Labs will market the vaccine in India and supply to the government and also to the private market.

· There is still lack of clarity on the pricing front and DRL is in deliberations with RDIF and the Indian government. Serum Institute of India, which manufactures and markets AstraZeneca vaccine has announced separate pricings for the government and for the private market. RDIF has announced a price of $10 per dose for Sputnik V earlier.