RDIF, Dr Reddy's Lab tie up for Sputnik V human trials, distribution of 100 mn doses of the COVID-19 vaccine in India
As of 1 August, Phase I and II of the vaccine were complete and by 11 August, Russian President Vladimir Putin had registered it as the world's first vaccine.
Indian pharma giant Dr Reddy’s Laboratories Ltd and the Russian Direct Investment Fund (RDIF) have partnered up to conduct clinical trials for the Russian Sputnik V vaccine. Dr Reddy's will also take on distribution of some 100 million doses of the vaccine in India after Phase 3 human trials are completed, and approvals granted by Indian regulators.
Delivery of the vaccine is expected to happen by November 2020.
The Sputnik V vaccine is being developed by the Gamaleya Research Institute along with the Russian Defence ministry. As of 1 August, Phase I and II trials for safety testing of the vaccine are complete. By 11 August, Russian President Vladimir Putin had announced that the vaccine was "registered" – the world's first vaccine against COVID-19. Only recently did a team of researchers who conducted these trials published results in The Lancet.
They reported no major adverse effects, and a stable immune response generated in all trial volunteers – both of which are important considerations in a successful vaccine trial.
The vaccine will now go through what the Russians are calling 'post-registration clinical trial' – the third phase of trials, including 40,000 volunteers. These trials are currently in various stages of recruitment and have been planned in Saudi Arabia, United Arab Emirates, the Philippines, India and Brazil. The results of these trials are expected to be published in October or November 2020.
The vaccine is expected to provide immunity from the coronavirus for up to two years, according to the Russian Health Ministry.
Speaking of the benefits of a prompt vaccination drive in India, the CEO of the Russian Direct Investment Fund Kirill Dmitriev, said in a statement, “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," he added.
G V Prasad, Co-Chairman and Managing Director of Dr Reddy’s Laboratories said in a statement, "The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID-19 in India.”
RDIF has also signed deals with Brazil's Health Ministry to supply the country with up to 50 million doses of the vaccine. Mexico's Landsteiner Scientific pharmaceutical company has partnered with the RDIF to supply 32 million doses of the vaccine to vaccinate around 25 percent of the Mexican population. Both countries are expected to receive the vaccine in November 2020, once the third phase of clinical trials complete, and national regulators approve the vaccine.
Dmitriev also said, "RDIF partners will receive an effective and safe drug to fight the coronavirus. 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.”
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