Covid-19: Clinical trial of Russia’s Sputnik vaccine to begin next month, including in India

The clinical trials of Russian Sputnik-V coronavirus vaccine will begin next month in many countries, including India, confirmed Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF).

In an interview to a Russian news network, Dmitriev said, “The post-registration studies involving more than 40,000 people started in Russia on August 26, before AstraZeneca has started its Phase 3 trial in the US with 30,000 participants. Clinical trials in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month. The preliminary results of the Phase 3 trial will be published in October-November 2020.”

The announcement comes just days after Russia shared its “comprehensive data” on the vaccine’s safety with Indian authorities.

Following the publication of the results of Phase 1 and Phase 2 clinical trials of Sputnik V in The Lancet, India had asked for these details from the Gamaleya Research Institute of Epidemiology and Microbiology which is based in Moscow.

The Indo-Russia plans for the Covid-19 vaccine extends to “co-development”, “co-production”, “clinical trials”.

Russian envoy to India Nikolay Kudashev confirmed this during an interaction when he said, “As far as we know, with some necessary technical steps the vaccine would be ready to be widely used, including abroad. For this purpose, we also remain in close touch with our Indian partners on different levels to work out modalities of cooperation, which may include supplies, co-development and co-production.”

Last month the Russian envoy had met with top officials of the health ministry, including Renu Swarup, Secretary, Department of Biotechnology, and principal advisor to the PM as well, seeking partnership in the production of the vaccine.

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The matter also came up during Defence Minister Rajnath Singh’s meeting with his counterpart Sergey Shoigu on the sidelines of the Shanghai Cooperation Organisation (SCO) ministerial meet in Moscow.

The Indian defence minister had congratulated the Russian government and its scientists for developing a vaccine against Covid-19.

To a question on why Sputnik-V has become eligible for emergency use registration, the RDIF CEO said, “Because of the very positive results of the Phase 1-2 trials and because the human adenoviral vector-based delivery platform has been proven the safest vaccine delivery platform over decades including through 75 international scientific publications and in more than 250 clinical trials.

“So Russia registered the vaccine because it had a previously approved, a safe and efficient human adenovirus delivery platform for other illnesses. Since the registration of Sputnik V in Russia, other countries also announced plans to follow the Russian approach for emergency use registration of their vaccines. Sinovac Biotech’s vaccine received a similar approval in China. The government of the United Kingdom and the head of the US Food and Drug Administration (FDA) Stephen Hahn have signaled potential for fast-track registration for British and American vaccine makers, respectively, despite their earlier reservation,” he added.

While India and Russia are in advanced stages of talks and clinical trial could begin in India along with Saudi Arabia, UAE, the Philippines and Brazil, External Affairs Minister will be in Moscow too from Sept 8-11 for the SCO meet on the sidelines of which bilateral meeting will be held with Russian foreign minister Sergey Lavrov. Both sides are expected to discuss cooperation on the vaccine front.

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