• Monday, Oct 26, 2020
  • Last Update : 10:13 am

Russian Covid-19 vaccine Sputnik V gets nod for clinical trial in India

  • Published at 11:58 pm October 17th, 2020
covid-19 vaccine
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On August 11, Sputnik V became the world’s first registered vaccine against Covid-19

Sputnik V, the world’s first registered vaccine developed by Russia against Covid-19, has been approved for conducting an adaptive phase 2 and 3 trial in India.

This was announced in a joint statement by Dr Reddy’s Laboratories Ltd, a multinational pharmaceutical company in India and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, on Saturday.

The statement said Dr Reddy’s Laboratories and RDIF have received approval from the Drug Control General of India to conduct “an adaptive phase 2 and 3 clinical trial for Sputnik V vaccine in India”.

This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study, it said.

Earlier in September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.

As part of the partnership, RDIF is set to supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India, IANS, an independent newswire, report said on Saturday.

Quoting the statement, the report said 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 organizations to have a diversified anti-Covid vaccine portfolio to protect their populations,” it added.

G V Prasad, co-chairman and managing director of Dr Reddy’s, said: “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.

Kirill Dmitriev, CEO of the RDIF, said: “We are pleased to collaborate with the Indian regulators and in addition to the Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial.”

On August 11, 2020, Sputnik V, developed by the Gamaleya National Center of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vectors platform.

Sputnik V is currently undergoing phase 3 clinical trials in Russia. Besides, the phase 3 clinical trial of the vaccine commenced in the UAE last week, the IANS report said.

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