Russia’s Sputnik V COVID-19 vaccine gets DCGI nod for clinical trials in India

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The COVID-19 pandemic has taken a heavy toll in terms of human lives lost across the world in the last few months. But now experts say that there may be a vaccine as soon as the end of this year. Even in India, the Health Ministry had recently announced that vaccines may be available as early as January 2021. Almost all vaccines are now at the end stage of human trials, despite setbacks along the way. Against this backdrop, the Drug Controller General of India (DCGI) has granted approval to Dr Reddy’s, a global pharmaceutical company headquartered in India, to conduct phase 2 and 3 clinical human trials of the Sputnik V, a COVID-19 vaccine made by Russia. On September 16, the Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories Limited had agreed to cooperate on clinical trials and distribution of Sputnik V Covid-19 vaccine in India. Also Read – Congenital heart defects not linked to severe COVID-19 symptoms

Sputnik V: Russia’s adenovirus vector-based vaccine

Sputnik V, an adenovirus vector-based vaccine, was developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology, along with the Russian Direct Investment Fund and registered on August 11. Co-chairman and Managing Director of Dr Reddy’s Laboratories G.V. Prasad in a statement said “This is a significant development that allows us to commence the clinical trials in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.” Also Read – COVID-19 Live Updates: Cases in India surge to 74,32,680 while death toll reaches 1,12,998

Vaccine delivery may be by late 2020

“On regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic,” a statement from the Russian fund had earlier stated. The Russian Direct Investment Fund had also said that the deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India. “The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organisations to have a diversified anti-COVID vaccine portfolio to protect their populations,” RDIF added. Also Read – WHO Solidarity trial: Remdesivir has no substantial effect on mortality in COVID-19 patients

India’s potential in vaccine market

Early in September, the news agency ANI had quoted Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), saying, “We do recognise India and it’s potential to become one of the support for the production of the vaccine not only in Indian markets but for other countries too. We very much appreciate the well- balanced approach expressed by the Indian partners as from the very beginning they started asking questions how our vaccine works and we appreciate it that they did not try to attack our vaccine but try to understand it.” The Russian government had approached the Indian government through appropriate channels and sought help on two counts – to consider its manufacturing through a network of companies that are well-known for vaccine manufacturing of high quality. The second request was, if need be, Phase-3 or any bridging studies be conducted in India.

(With inputs from IANS)

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