Dr. Reddy's Laboratories on Wednesday announced that it has inked a deal with the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Following regulatory approval in India, RDIF will supply to Dr. Reddy's 100 million doses of the vaccine.
"Deliveries could potentially begin in late 2020, subject to completion of successful trials and registration of the vaccine by regulatory authorities in India," Dr. Reddy's said in a filing to the BSE.
COVID-19 vaccine Sputnik V, which is based on human adenoviral vector platform with proven safety, is undergoing clinical trials.
The company stated that the agreement between RDIF and Dr. Reddy's reflects the growing awareness of countries and organisations to have a diversified anti-COVID vaccine portfolio to protect their populations.
G V Prasad, Co-Chairman & Managing Director of Dr. Reddy's Laboratories, said the company has partnered with RDIF to bring the vaccine to India. The Phase I and II clinical trials have shown promising results, while Phase III trials are underway 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," Prasad said.
Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital in Moscow, said, "The main criteria for evaluating a vaccine are safety and efficacy. In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we repeatedly encounter throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform."
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Russian Ministry of Health 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 per cent of participants. 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 2020.