Russian Direct Investment Fund has inked a deal with Dr. Reddy’s Laboratories to conduct a clinical trial and distribution of Sputnik V in India. Under the agreement, Russia’s sovereign wealth fund will supply 100 million doses of Russia’s COVID-19 vaccine to Indian drug maker. Both the trials and supply deal depend on central drug regulator’s approval. If the trials are successful, the vaccine will be available in India as by the end of this year.
“India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against covid-19,” RDIF chief executive officer Kirill Dmitriev said in a statement.
Commenting on the tie-up, G V Prasad, co-chairman & managing director of Dr. Reddy’s Laboratories said, “We will be conducting Phase-III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India.”
Last week NITI Aayog member (health) V.K. Paul said the Indian government is willing to facilitate a phase 3 trial for Russia’s Sputnik V vaccine for which 2-4 Indian companies are in discussions to mass manufacture.
Russia became the first country in the world to register a COVID-19 vaccine after less than two months of human testing. Developed by Gamaleya Research Institute and the Russian defence ministry, the vaccine underwent necessary tests, Russia claimed. Russian President Vladimir Putin said at the time that full-scale production was due to start in September.
Russia health ministry claimed that the coronavirus vaccine offers lasting immunity from the virus. The vaccine is expected to provide immunity from the coronavirus for up to two years, according to health ministry.
“The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.” Dmitriev said.
Early results from trials of Russia’s potential coronavirus vaccine show no major negative side effects, a study published in the peer-reviewed medical journal The Lancet revealed.
“The two 42-day trials – including 38 healthy adults each – did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response,” the study’s authors wrote.
Russian Health Minister Mikhail Murashko told last week that the first batch of Russia’s COVID-19 vaccine was likely to be delivered to all regions of the country by 14 September, according to TASS.
Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November this year.
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