The Russian Direct Investment Fund (RDIF) – Russia’s sovereign wealth fund, and India’s leading generic pharmaceutical firm Hetero Biopharma will produce over 100 million doses of COVID-19 vaccine Sputnik V in India annually. Production of the vaccine is expected to commerce from early 2021.
The Gamaleya Center and RDIF announced on November 24 positive results obtained during the second interim data analysis of the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers. Interim trial results have confirmed the high efficacy of the Sputnik V vaccine, the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors. The analysis demonstrated a 91.4 per cent efficacy rate for Sputnik V vaccine.
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.
“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% 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. Thanks to our cooperation with Hetero, we will be able to significantly increase production capacity and provide people of India with an efficient solution in this challenging period of the pandemic,” Kirill Dmitriev, RDIF CEO said.
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. This collaboration is another step towards our commitment in the battle against Covid-19 and realizing the objective of ‘Make-in-India’ campaign as envisioned by our Hon’ble Prime Minister of India.”