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

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NEW DELHI, Oct 18, 2020 (BSS) – 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 Reddys 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 that Dr Reddys Laboratory 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 randomised controlled study, which
will include safety and immunogenicity study, it said.

Earlier in September 2020, Dr Reddys 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 Reddys upon regulatory approval in India, an
IANS, an Independent Newswire, report said here yesterday.

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

G V Prasad, Co-chairman and Managing Director, 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 Russian Direct Investment Fund said,
“We are pleased to collaborate with the Indian regulators and in
addition to 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
Research Institute 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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