Russian Direct Investment Fund (RDIF) and Dr. Reddy’s Laboratories have agreed to cooperate on clinical trials and distribution of the Sputnik V coronavirus vaccine in India.
After receiving regulatory approval in India, the Russian sovereign wealth fund will supply 100 million doses of the vaccine to Dr. Reddy’s.
The Sputnik V coronavirus vaccine, which is based on human adenoviral vector platform, is being assessed in clinical trials for the prevention of Covid-19.
Prof. Sergey Tsarenko – Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No. 52 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.”
According to Dr. Reddy’s, deliveries of the Sputnik V Covid-19 vaccine could potentially start in late 2020, which will be subject to the completion of successful trials and registration of the vaccine by Indian regulatory authorities.
Dr Reddy’s said that the agreement with RDIF reflects the increasing awareness of countries and organizations to have a diversified vaccine portfolio for Covid-19 for protecting their populations.
Kirill Dmitriev – CEO of the Russian Direct Investment Fund, commenting on the Sputnik V coronavirus vaccine, said: “We are very pleased to partner with Dr. Reddy’s in India. Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India.
“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 partners will receive an effective and safe drug to fight the coronavirus.”
In early August, the Russian health ministry approved the Sputnik V vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, for prevention against Covid-19.
In September, a research paper on the findings of the phase 1 and phase 2 clinical trials of the Sputnik V Covid-19 vaccine was published in The Lancet. The trials showed that there were no serious adverse effects and that the vaccine triggered a stable immune response in all the participants.
Clinical trials of the Sputnik V coronavirus vaccine featuring 40,000 volunteers are currently going on. The first results of these post-registration trials are anticipated to be published in October-November 2020.
G V Prasad – Co-Chairman and Managing Director of Dr. Reddy’s Laboratories, commenting on the Russian Covid-19 vaccine, said: “We are pleased to partner with RDIF to bring the vaccine to India. 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. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India.”