Hyderabad-based Hetero Drug has become the second Indian company after Dr Reddy's Laboratories entered into an alliance to supply Russia's COVID-19 vaccine Sputnik-V in India. Russia's sovereign wealth fund Russian Direct Investment Fund (RDIF) and Hetero have agreed to produce in India over 100 million doses per year and production will start in the beginning of 2021, said the partners.
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. RDIF had earlier said Russia and its partners will have the capacity to make more than a billion doses of Sputnik V from next year -- enough to vaccinate over 50 crore people. The vaccine would be made available at $20 per dose. Dr Reddy's, which is yet to clarify about its manufacturing plans officially, had earlier entered into a deal with RDIF to supply 100 million doses of the vaccine in India.
"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," said B. Murali Krishna Reddy, Director - International Marketing, Hetero Labs. "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," said Kirill Dmitriev, CEO of the Russian Direct Investment Fund.
RDIF said requests for more than 1.2 billion doses of Sputnik V vaccine has come 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. The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades - while the history of use of human adenoviruses in vaccine development started in 1953. Adenovirus vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body, said the communication. The Russian vaccine use two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses. So, preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95 per cent.
Russia's 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. Russia claims the vaccine demonstrated a 91.4 per cent efficacy rate for the Sputnik-V vaccine in the initial data.