Indian pharmaceutical company Hetero is to manufacture more than 100 million doses of the Russian Sputnik V COVID-19 vaccine per year under the terms of a deal unveiled yesterday between it and the Russian Direct Investment Fund (RDIF).
Under the plan, which the sovereign wealth fund cast as another step in its efforts to scale up international manufacturing of its flagship vaccine, Hetero would begin production in India at the start of next year, according to a joint statement on the Sputnik V Twitter account.
The statement said that phase 2 and 3 clinical trials were under way in India, which with a population of more than 1.3 billion people is the second-most populated country in the world after China.
Although Russian authorities gave Sputnik V their regulatory approval under an accelerated procedure in August, trials in Russia, designed to assess its safety and efficacy, are also ongoing.
“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,” Hetero director of international marketing B. Murali Krishna Reddy said.
The deal chimed with an objective being promoted by the Indian prime minister of making things in the nation, Reddy said.
Another Indian drugmaker, Dr Reddy’s Laboratories Ltd, is conducting clinical trials of Sputnik V in India, and has said that it expects late-stage trials to be completed by March.
RDIF has spoken of Dr Reddy’s being involved with distribution once Sputnik V gets regulatory approval in India.
RDIF head Kirill Dmitriev said earlier this week that Moscow and its foreign partners had the capacity to make more than 1 billion doses of Sputnik V starting from next year — enough to vaccinate more than 500 million people — and that it would cost less than US$20 per person on international markets.
Yesterday’s joint statement said that Sputnik V Phase III clinical trials were also under way in Belarus, Venezuela and other countries.
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