Accelerated development and implementation of the prophylactic vaccine Sputnik V in the conditions of the COVID-19 pandemic
Primarily, an effective response to the COVID-19 pandemic is the accelerated development and implementation of prophylactic vaccines, suitable for mass vaccination. Effective prevention is the only way to simultaneously preserve the health of citizens and bring the economy out of recession. We have practically worked out a protocol that allows us to reduce the time from the development of a candidate vaccine against COVID-19 to its introduction to six months, followed by obtaining convincing data on efficacy on tens of thousands of volunteers in less than 4 months. This approach is versatile and can be reused in the context of other zoonotic virus pandemics.
Achieving the SDGs by 2030 involves supporting science and development aimed at introduction universal access to vaccines that are economically affordable for everyone. We have developed an adenoviral vaccine platform that allows us to create candidate vaccine preparations, test and introduce them using a typical approach. The created cooperation brings together the efforts of a dozen scientific groups in the Gamaleya Centre, as well as partner organizations, allowing a pilot batch of the medicine to be produced in a short time, to create the necessary infectious models, to assess the safety, immunogenicity, and efficacy of a candidate vaccine. Established close partnerships with clinical centres enable rapid deployment of a clinical trial. Key biopharma cooperation allows quick launch of the production of a vaccine for its mass use. Cooperation between the key biotechnological enterprises makes it possible to quickly transfer the developed protocols to launch the production of a vaccine for its mass use. Since the basic up and downstream processes have been worked out validation of the production process becomes cheaper and faster.
Development of an effective vaccine in the context of the COVID-19 pandemic is a significant contribution to achieving the SDGs on health and well-being. However, to best match the parameters of vaccine medicine availability and the balance between the speed of development and the possibility of its mass use, we chose the adenoviral platform, which allows us to obtain a vaccine of high effectiveness, safety and at the same time cost effective and unpretentious to the requirements of the cold chain. The created vaccine has the best combination of price and effectiveness among the available vaccines against COVID-19.
To achieve the goal of the project on accelerated development and implementation of Sputnik V, an intensive plan was designed, implying the parallel execution of tasks in all areas of development, which allows for a reduction in the time of transition from stage to stage and advance the study of each of the new stages in a proactive mode. A classic application development plan includes a relatively small number of stakeholders, allows for the use of competitive principles when defining affiliate programs, and is tied to a relatively small number of sponsors. This standard development bar is completely unsuitable for accelerating vaccination development and deployment in a pandemic. Sputnik V vaccine development plan envisioned a dramatic acceleration of research and development at great risks. The priority of the project in close connection with the sponsor represented by the Ministry of Health of the Russian Federation was set as maximum. The best research groups of the Gamaleya Center were involved in the project to carry it out, including about 70 researchers from the Gamaleya Center, as well as two dozen specialists from various organizations. All tasks were divided into component blocks, including the development of a vaccine preparation, production of preparation for preclinical and clinical studies, virus isolation and creation of an infectious model, conducting experiments to assess safety, working out protocols for assessing immunogenicity, creating analytical systems such as RT-PCR and ELISA, evaluating the effectiveness in animal models, preparing a clinical trial protocol, launching clinical trial protocols, communicating with all interested external parties. Multisource funding principles were involved, including federal and local budgets, as well as sponsorship funding.
The main result of the proven practice of accelerated vaccine development is the creation of Sputnik V vaccine with the best combination of efficacy, cost, and cold chain temperature requirements in less than six months. Accelerated development made it possible, in less than six months, to obtain a medicine that was proposed for the vaccination of hundreds of thousands of medical workers and teachers in the Russian Federation. TAs a result of the third phase of clinical trials, the vaccine's proven efficacy was 91.6%. The cost of the vaccine was one of the lowest among the medicines, less than $ 10 per dose. The temperature regime made it possible to store and use the cold chain at 2-8 degrees Celsius. These parameters make it possible soon to make Sputnik V available worldwide to the maximum number of people in a short time. Reducing morbidity among those who received Sputnik V vaccine and increasing herd immunity will allow people to return to living conditions as quickly as possible and to prevent the development of another “wave” of the pandemic.
The driving factor of Sputnik V accelerated vaccine development and deployment initiative is the growing threat posed by the pandemic. It allowed to prioritize the plan for the implementation of research and development, as well as to consolidate the necessary budget. Also, contributing factors were the presence of a basic adenovirus platform and a team, capable of working professionally in all areas of development almost simultaneously. Negative factors of promotion are interdepartmental competition, the anti-vaccination position of society, distrust of society in emerging technologies. The ratio of costs to benefits will be exceptionally good.
The experience gained shows that in a pandemic it is possible to accelerate the development. Key elements for a fast-track development protocol iteration are consolidated human and financial resources, access to scientific and industrial infrastructure, and a clinical base. Equally important is the support at a high state level and the reduction of administrative barriers and the timing of the examination of documents. The importance of reducing the distance between scientific institutions and the biopharmaceutical industry. Therefore almost any strong research institution, with an adequate vaccine platform with high potential, with connections in the manufacturing sector and support from the country's leadership, provided with the necessary financial resources, can reproduce the path traveled. We will try to introduce a protocol for solving other biomedical problems, for example, in the field of creating a vaccine against tuberculosis and other infectious diseases.
The proposed practice and its outcome will be essential in the fight against COVID-19 and the speed of recovery of society and the economy disrupted by the pandemic. The pandemic has become the main driving factor for the implementation of our initiative, but Sputnik V will be one of the key tools in the fight against the pandemic. Using the vaccine to create herd immunity in countries will allow them to return to normal conditions. The rapid development protocol that has been developed could provide an incentive for many countries to use it to tackle other regional infectious problems. One can imagine the creation of a vaccine against HIV, tuberculosis, dengue, and many other vaccines necessary to reduce the impact of infectious agents on the well-being of people around the world.
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The Gam-COVID-Vac vaccine (Sputnik V) has been registered in more than 50 countries, including countries in the Americas, the Middle East, Europe, Asia and Africa.