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.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
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.