The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd (Dr. Reddy’s), a global pharmaceutical company headquartered out of India, on Wednesday agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India.
Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic.
Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
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, Dr Reddy’s said.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, 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. 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.”
G V Prasad, Co-Chairman and Managing Director of Dr. Reddy’s Laboratories 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.”
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% 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.