The Russian Direct Investment Fund (RDIF) and Hyderabad based Hetero Labs, through its biologics arm Hetero Biopharma, have agreed to produce in India over 100 million doses per year of the world’s first registered vaccine against the novel coronavirus infection – Sputnik V.

The parties intend to start the production of Sputnik V in the beginning of 2021.

The Gamaleya Center and RDIF announced on November 24 positive results obtained during the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers.

Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India. Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.

Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented,  “We are delighted to announce the agreement between RDIF and Hetero that will pave the way to production of the safe and highly effective Sputnik V vaccine on Indian soil. The vaccine’s interim clinical trial results show 95 per cent efficacy on the 42nd day after the first dose. I am confident that Sputnik V should become an integral part of the national vaccine portfolio of every country willing to protect its population from the coronavirus.”

B Murali Krishna Reddy, Director – International Marketing, Hetero Labs Limited said, “We are pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine for the treatment of COVID-19.  While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients.”