New Delhi: The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, has tied up with Indian generic pharmaceutical firm Hetero for the production of 100 million doses of the Sputnik V Covid-19 vaccine annually in India. Production will begin next year.
Earlier, Dr Reddy’s Laboratories had tied up with RDIF for the conduct of clinical trials in India and is currently collaborating with the government’s Department of Biotechnology for the same.
Sputnik V is the only licensed Covid vaccine in the world right now.
In a statement, RDIF CEO Kirill Dmitriev said, “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.”
Dmitriev expressed confidence that Sputnik V could 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,” he added.
The Gamaleya Center, which developed the vaccine, and RDIF announced on 24 November that the vaccine showed an efficacy of 91.4 per cent during the second interim data analysis of the double-blind, randomised, placebo-controlled Phase 3 clinical trials involving 40,000 volunteers.
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Clinical trials underway in several countries, including India
Indian drug regulatory norms require pharmaceutical products that have cleared phase 3 trials elsewhere to undergo Phase 3 trials again on Indian subjects.
Sputnik V is currently in its Phase 2/3 clinical trials in India. Phase 3 trials are also on in Belarus, the UAE and Venezuela.
The vaccine is unique in its use of two different vectors based on the human adenovirus, which, the makers claim, allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses.
The vaccine, it has already been announced, will be priced at $10 (around Rs 740) per dose and two doses will be required for protection against Covid-19. It is priced higher than the one developed by Oxford University — currently also in Phase 3 trials in India — at $3-6 (around Rs 220-440) per dose but is more affordable than the mRNA vaccines of Pfizer and Moderna, which, it is estimated, will cost three times that amount.
Pleased with collaboration, says Hetero
B. Murali Krishna Reddy, director, international marketing, Hetero Labs Ltd said the company is “pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine”.
“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 realising the objective of ‘Make-in-India’ campaign as envisioned by our Hon’ble Prime Minister of India,” said Reddy.
Hetero is the world’s largest producer of anti-retroviral drugs. It has 36 state-of-the-art manufacturing facilities strategically located worldwide.
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