Hyderabad-based Dr Reddy's Laboratories (Dr Reddy's) and Russia's sovereign wealth fund Russian Direct Investment Fund (RDIF) have joined hands to carry out clinical trials and distribution of 100 million doses of coronavirus vaccine Sputnik V in India.
Sputnik V vaccine is undergoing final stage clinical trials in Russia. It is also being tested in several other countries. "Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India," a joint statement issued by RDIF and Dr Reddy's says.
"We are pleased to partner with Dr Reddy's in India. Dr Reddy's has had a well-established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is among 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," Kirill Dmitriev, CEO of the Russian Direct Investment Fund said.
G V Prasad, Co-Chairman and Managing Director of Dr Reddy's said that the Phase I and II results of Sputnik V vaccine have shown promise, and Dr Reddy's will be conducting Phase-III trials in India 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.
"The main criteria for evaluating a vaccine is 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," said Prof. Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No. 52 in Moscow.
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.
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.