2 | Next crop of COVID-19 vaccine developers take more traditional route: The handful of drugmakers dominating the global coronavirus vaccine race are pushing the boundaries of vaccine technology. The next crop under development feature more conventional, proven designs. The world will need several different vaccines to fight the COVID-19 pandemic, given the sheer size of global need, variations in effects on different populations, and possible limits of effectiveness in the first crop. Many leading candidates now in final-stage testing are based on new, largely unproven technology platforms designed to produce vaccines at speed.
Dr Reddy's and the Russian Direct Investment Fund (RDIF) have agreed to conduct clinical trials and distribute 100 million doses of Russia's Sputnik V Covid-19 vaccine in India.
The RDIF is Russia's sovereign wealth fund.
"Upon regulatory approval in India, the RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine," said Dr Reddy's in a statement.
The Sputnik V vaccine, which is based on human adenoviral vector platform, is undergoing clinical trials.
Deliveries could potentially begin in late 2020, subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
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"The agreement between the 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," said Kirill Dmitriev, chief executive officer of the RDIF.
“India is amongst most severely impacted countries from the COVID-19 pandemic and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to the country in the battle against COVID-19," Dmitriev added.
The RDIF said its partners will receive an effective and safe drug to fight the novel 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.
“The Phase I and II clinical trials have shown promising results. 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. The Sputnik V vaccine could provide a credible option in our fight against COVID-19 in India,” said GV Prasad, co-chairman and managing director of Dr Reddy’s.
On August 11, the Sputnik V vaccine 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.
On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100 percent of participants.
The 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 the post-registration trials. The first results of these trials are expected to be published in October-November 2020.