Aditi tandon
Tribune News Service
New Delhi, September 16
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd (Dr. Reddy’s), an India-based global pharmaceutical company, agreed on Wednesday to cooperate on clinical trials and distribution of Sputnik V vaccine in India.
Following regulatory approval in India, RDIF will supply Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on a 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 the 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 organizations to have a diversified portfolio of COVID vaccines to protect their populations, Dr. Reddy’s said.
Kirill Dmitriev, Executive Director of the Russian Direct Investment Fund, said: “We are very pleased to be partnering 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 among the countries most affected by COVID 19 and we believe that our human adenovirus dual vector platform will provide a safe and scientifically validated option for India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to combat the coronavirus. The human adenoviral vector platform, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades and has been shown to be safe with no potential long-term negative consequences. “
GV Prasad, Co-President and Managing Director of Dr. Reddy’s Laboratories said: “We are pleased to partner with RDIF to bring the vaccine to India. Phase I and II clinical trials have shown promising results. We will conduct phase III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of Indian regulators. The 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 Russian Ministry of Health and became the world’s first registered vaccine against COVID-19 based on the platform of human adenoviral vectors.
On September 4, a research article on the results of the phase I and phase II clinical trials of the Sputnik V vaccine was published in The Lancet, a leading international medical journal, showing that there are no serious adverse effects and a stable immune response in 100% of participants. Post-registration clinical trials of the Sputnik V vaccine are currently underway involving 40,000 volunteers. More than 55,000 volunteers have applied to participate in post-registration tests. The first results of these trials are expected to be published in October-November 2020.