Sputnik V gets DCGI nod for clinical trials in India

The COVID-19 pandemic has taken a heavy toll in phrases of human lives misplaced internationally in the previous few months. But now specialists say that there could also be a vaccine as quickly as the tip of this yr. Even in India, the Health Ministry had lately introduced that vaccines could also be accessible as early as January 2021. Almost all vaccines are actually on the finish stage of human trials, regardless of setbacks alongside the way in which. Against this backdrop, the Drug Controller General of India (DCGI) has granted approval to Dr Reddy’s, a world pharmaceutical firm headquartered in India, to conduct section 2 and three 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 coronary heart defects not linked to extreme COVID-19 signs

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, together 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 press release stated “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 whereas demise toll reaches 1,12,998

Vaccine supply could also 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 press release from the Russian fund had earlier acknowledged. The Russian Direct Investment Fund had additionally stated that the deliveries might probably start in late 2020 topic to completion of profitable 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 impact on mortality in COVID-19 sufferers

India’s potential in vaccine market

Early in September, the information company 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 authorities had approached the Indian authorities by means of acceptable channels and sought assistance on two counts – to think about its manufacturing by means of a community of firms which can be well-known for vaccine manufacturing of top of the range. The second request was, if want be, Phase-3 or any bridging research be carried out in India.

(With inputs from IANS)

Published : October 17, 2020 7:08 pm


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