INDIAN drug firm Hetero will produce 100 million doses of the Russian Sputnik V Covid-19 vaccine per year, the Russian Direct Investment Fund (RDIF) said on Friday(27).
It added that the production is expected to start in early 2021.
The RDIF statement said Phase II-III clinical trials were still under way in India. Trials to gauge safety and efficacy of the vaccine are also continuing in Russia.
The phase III clinical trials of the vaccine were also under way in Belarus, the UAE, Venezuela and other countries.
Russian authorities, however, gave Sputnik V their regulatory approval under an accelerated procedure in August.
“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, Hetero’s director of international marketing.
Another Indian drugmaker, Dr Reddy’s Laboratories Ltd , is conducting clinical trials of Sputnik V in India, and has said it expects late-stage trials to be completed by March 2021.
RDIF has spoken of Dr Reddy’s being involved with distribution once Sputnik V gets regulatory approval in India.
Kirill Dmitriev, RDIF head, said earlier this week that Moscow and its foreign partners had the capacity to make more than a billion doses of Sputnik V starting from next year — enough to vaccinate over 500 million people — and that it would cost under $20 per person on international markets.
Besides India, the Sputnik V vaccine will also be produced in Brazil, China and South Korea.
The RDIF and the Gamaleya National Center has recently claimed that interim clinical trial data had shown that Sputnik V was 91.4 per cent effective on day 28 and over 95 per cent effective on day 42.
India’s tally of Covid-19 infections stands at 9.27 million, the second-highest in the world after the US, with more than 135,000 deaths.
