“Sputnik V” is an adenovirus vector-based Vaccine that is currently the first registered COVID-19 Vaccine across the globe. It has been developed by Gamaleya National Center of Epidemiology and Microbiology, Moscow, Russia, for prevention of Coronavirus infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV- 2).
Sputnik V has been registered as a COVID-19 Vaccine by the Russian Ministry of Health on 11-08-2020. Russian Direct Investment Fund (RDIF), which is Russia’s Sovereign Wealth Fund, has submitted applications for accelerated registration (Emergency Use Listing) and prequalification of Sputnik V, to the World Health Organisation (WHO) and is awaiting approval of the same.
The Prequalification of Medicines Programme (PQP) is a leading United Nations Programme that is managed by WHO. PQP is the only Global Medicines Quality Assurance Programme which assesses, inspects and evaluates the medicinal product and its active pharmaceutical ingredient(s), etc and thereafter, verifies whether they are compliant with WHO standards, WHO Good Clinical Practices and WHO Good Laboratory Practices.
The Prequalification Team may also provide listing of the medicinal product on an emergency basis (Emergency Use Listing), in a situation where a public health emergency (PHE) has occurred and there is limited available data about the efficacy and safety of the products and lack or paucity of diagnosis, treatment, detection and/or prevention options.
Thus, the prequalification of Sputnik V would allow the Vaccine to be included in the Pre-Qualified List of Medicinal Products that meet leading quality, safety and efficacy standards of WHO. Further, the accelerated registration of Sputnik V would make this Vaccine easily accessible to all countries within a short period of time and with less procedural hassles.
Various other countries are also in the process of developing COVID-19 vaccines such as Germany, U.S.A., India, etc. However, these vaccines are still in their initial phases of Clinical Trials.
In comparison, “Sputnik V” has beaten the others as it is presently the only registered COVID-19 Vaccine in the world that is said to be safe and effective and is currently undergoing Phase 3 Clinical Trials, where the efficacy of the Vaccine is tested on a large-scale basis. Russia has already successfully completed Phases 1 and 2 of the Clinical Trials. The Clinical Trials have shown the Vaccine as effective and safe.
This Vaccine is based on adenovirus vector which induces a genetic material into the body’s cell(s) to provoke an immune response. These vectors will act as a Trojan Horse and will send instructions to the cells in the human body to produce the spike protein of SARSCoV-2, the Virus responsible for causing COVID-19. This inserted genetic element is safe for the body and helps the immune system to react and produce antibodies, which protects the body from infection. Also, the use of these human adenoviruses as vectors is safe because these viruses, which cause common cold, are not novel and have been in existence for a number of years.
One, Mr. Alexander Chepurnov, Professor of Virology and an Employee of the Novosibirsk Federal Research Centre of Basic and Translational Medicine, Russia, had contracted Coronavirus twice for the sake of an experiment that was carried out to find out, for how long the Covid Antibodies would protect him from repeat contraction of the Disease. He concluded that one-time administration of the Vaccine may not be sufficient to maintain the immunity and thus, recommended that periodic vaccination of Sputnik V would achieve efficient results.
Additionally, Russia has also registered a second COVID-19 Vaccine, namely, EpiVacCorona in October, 2020. The said Vaccine has been developed by Vektor State Research Centre of Virology and Biotechnology in Russia.
EpiVacCorona Vaccine is an antigens-based Vaccine that provokes an immune reaction against COVID-19 and helps in further development of immunity. This is currently undergoing Phase 3 Clinical Trials.
Further, Russia has registered a third COVID-19 Vaccine and is in the process of working on the next generation vaccines. These Vaccines will be announced shortly.
These Russian Vaccines would be first made available to Russian citizens on a priority basis. Thereafter, the Vaccine would be made available for widespread use on commercial basis in foreign markets by 01-01-2021, which will commensurate with the conclusion of Phase 3 Clinical Trials.
The Russian Government has already executed preliminary agreements for testing Sputnik V with more than 20 countries inter alia Brazil, Mexico, India, Venezuela, Saudi Arabia, Uzbekistan, Nepal.
In India, Dr. Reddy’s Laboratories and RDIF have already entered into an Agreement around 16-09-2020, whereby, RDIF has agreed to supply 100 Million doses of the Sputnik V Vaccine to Dr. Reddy’s for conducting Clinical Trials of the Vaccine and for its distribution in India. The Drug Controller General of India (DCGI) has granted approval to Dr Reddy`s to conduct Phases 2 and 3 Clinical Human Trials of Sputnik V around 17-10-2020.
Russians are looking at a long-term cooperation with the joint venture partners in different parts of the world. Our Client who is a Russian, can facilitate necessary support from the Russian Government and other official Russian organizations in order to promote setting up and commencement of business for the joint venture.
Interested parties may reach us at email@example.com to enable us to connect them to the Russian Client.
Sushila Ram Varma
The Indian Lawyer & Allied Services
Advisor to Russian Business Entrepreneurs and Companies