RDIF and the Gamaleya Center announce international scientific advisory board on Sputnik V vaccine
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya (Gamaleya Center) announce the creation of an International Scientific Advisory Board on the Sputnik V vaccine – the world’s first registered vaccine against coronavirus.
Leading scientists in virology, microbiology, genetics and biotechnology from Argentina, Croatia, France, Germany, India, Russia, Sweden, UK and USA, representing top research and medical centers, have joined the Board.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: “RDIF and the Gamaleya Center initiated the creation of the International Scientific Advisory Board on the Sputnik V vaccine and the formation of an international platform where vaccine developers could exchange information, opinions and expertise with their leading foreign colleagues. This scientific exchange has become especially in demand due to the pandemic of the new coronavirus infection, a global problem that has stimulated the pooling of the entire global scientific and research potential. We are grateful to all the experts who accepted our offer and joined the Board. An international partnership, including on the coronavirus vaccine, is the key to the ultimate victory and proves once again that the noble goal of saving lives has no boundaries.”
Sputnik V is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. It currently ranks among top-10 candidate vaccines approaching the end of clinical trials and the start of mass production on the World Health Organization’s (WHO) list.
The ongoing Sputnik V post-registration clinical trial in Russia involves 40,000 volunteers. Clinical trials of Sputnik V have been announced in the UAE, India, Venezuela and Belarus.
The Sputnik V vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials. The Sputnik V vaccine efficacy against severe cases of coronavirus is 100%.
RDIF jointly with partners and manufacturers is ramping up the production of Sputnik V. The cost of one dose of the vaccine for international markets will be less than $10 (Sputnik V is a two dose vaccine). The lyophilized (dry) form of the vaccine can be stored at a temperature of +2 to +8 degrees Celsius.
Requests for more than 1.2 billion doses of the Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.
How adenoviral vector-based vaccines work
“Vectors” are vehicles, which can induce a genetic material from another virus into a cell. The gene from adenovirus, which causes the infection, is removed while a gene with the code of a protein from another virus spike is inserted. This inserted element is safe for the body but still helps the immune system to react and produce antibodies, which protect us from the infection.
The technological platform of adenovirus-based vectors makes it easier and faster to create new vaccines through modifying the initial carrier vector with genetic material from new emerging viruses that helps to create new vaccines in relatively short time. Such vaccines provoke a strong response from a human immune system.
Human adenoviruses are considered as some of the easiest to engineer in this way and therefore they have become very popular as vectors.
Safety and efficacy
After the start of the COVID-19 pandemic Russian researchers extracted a fragment of genetic material from novel coronavirus SARS-COV-2, which codes information about the structure of the spike S-protein, which forms the virus’ “crown” and is responsible for connection with human cells. They inserted it into a familiar adenovirus vector for delivery into a human cell creating the world’s first COVID-19 vaccine.
In order to ensure lasting immunity Russian scientists came up with a breakthrough idea to use two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine.
The use of human adenoviruses as vectors is safe because these viruses, which cause the common cold, are not novel and have been around for thousands of years.
Before the start of clinical trials the vaccine had gone through all stages of pre-clinical trials with experiments on different types of animals, including 2 types of primates.
Phase 1 and 2 clinical trials of the vaccine have been completed on August 1, 2020. All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine. The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including an analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.
Post-registration clinical trials involving more than 40,000 people in Russia and Belarus were launched on August 25, 2020. A number of countries, such as UAE, India, Venezuela, Egypt and Brazil will join the clinical trials of Sputnik V locally. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. The plan is to ramp up the vaccine production in Russia and globally.
The unique substance of the Sputnik V and method of using it has a patent protection in Russia, obtained by Gamaleya National Research Institute of Epidemiology and Microbiology.