Sputnik V is a Russian vaccine against the Covid-19. The prestigious scientific magazine finally released technical information on phase III of the Gamaleya Institute’s development against COVID-19, whose doses are applied in some African countries and other Latin American countries.
The scientific objection behind the vaccine Sputnik V on the validation of its Phase III results reviewed by international peers, as required by the work of science, was settled as of the publication today of its full evidence and efficacy study in the prestigious journal The Lancet.
The Russian vaccine developed by the Gamaleya Center published in The Lancet the results of the inoculant efficacy analyzes, finally peer-reviewed at an international level. In an interim analysis of a Phase III clinical trial, Sputnik V showed strong results in terms of efficacy, immunogenicity, and safety. The efficacy of the Sputnik V vaccine against COVID-19 is 91.6 percent.
The scientific process advanced towards the correct box, but Africa and the rest of the region – which opted for this vaccine as the only available supply in this first stage to pierce the pandemic against COVID-19, still await the promised doses. However, Algeria is planning to start its production of Sputnik V.
The announcement of the publication of the provisional results in The Lancet was confirmed by the Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and Russia through the Russian Direct Investment Fund (RDIF), where the high efficacy and safety of the vaccine is confirmed.
Sputnik V, based on a well-studied human adenoviral vector platform, is the world’s first registered vaccine against coronavirus.
In the interim efficacy analysis of the randomized, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo ), Treatment of two doses of Sputnik V administered 21 days apart demonstrated 91.6% efficacy against COVID-19.
The calculation is based on the analysis of 78 confirmed COVID-19 cases identified in the placebo group (62 cases) and in the vaccine group (16 cases). The inoculant “generated a strong humoral and cell-mediated immune response,” they reported in a document.
The expectation was high, more in North Africa and in general for the Latin American region, where Sputnik V is the only inoculant that is applied today and that it promised a large number of doses in line with the Oxford-AstraZeneca vaccine strategy.
Hildegund CJ Ertl, professor at The Wistar Institute Center for Vaccines and Immunotherapy, United States, stated, “The vaccine is 100% effective in preventing serious illness or death, which in the end is the most crucial parameter; We can all deal with sneezing as long as we stay out of the hospital or cemetery. Even after a single dose of the booster regimen, the protection conferred against the disease was 87.6%. Therefore, Sputnik V is more effective than the AstraZeneca or Johnson & Johnson vaccines. The Sputnik V vaccine, which, unlike the equally effective RNA vaccines from Pfizer and Moderna, can be stored in the refrigerator, will be of great value in fighting the global COVID-19 pandemic.”
For his part, Cecil Czerkinsky, PhD, Director of Research at the National Institute of Health and Medical Research (Inserm), France, said: “The interim results of phase 3 clinical trial of the adenoviral vector Sputnik V vaccine against COVID are quite impressive. This vaccine appears to be very effective and immunogenic in all age groups. This is clearly good news, as this dual formulation vaccine is comparatively easy to manufacture and deploy in a context of anticipated global vaccine shortages and logistical challenges in the deployment of newly licensed vaccines for emergency use, which they are sensitive to temperature ”.
The article, published in The Lancet, confirms the successful results and provides additional information on this vaccine’s efficacy and safety in different subgroups. From a public health point of view, the efficacy of the vaccine was very high. The safety profile was very good.
Alexander Gintsburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology, said: “The publication of international peer-reviewed data on the results of Sputnik V clinical trials is a great success in the global battle against the COVID-19 pandemic. The safety and high efficacy are demonstrated by the solid scientific data presented, and I congratulate the entire team at the Gamaleya National Research Center for this monumental achievement. Several human adenovirus-based vaccines have already been created, and this tool is one of the most promising for the development of new vaccines in the future.”
Kirill Dmitriev, Executive Director of Russia’s Direct Investment Fund, commented: “This is a great day in the fight against the COVID-19 pandemic. Data published by The Lancet shows that Sputnik V is the world’s first registered vaccine and one of the best. It fully protects against severe COVID-19 based on data that has been independently compiled and peer-reviewed, and then published in The Lancet. Sputnik V is one of only three vaccines globally with the efficacy of more than 90% efficacy, but it outperforms them in terms of safety and portability due to storage requirements of +2 to +8 degrees and a more affordable price. Sputnik V is a vaccine for all humanity.”
According to the peer-reviewed study results, the vaccine provides 100% complete protection against severe cases of the new coronavirus infection. Among the confirmed severe cases of COVID-19, 20 were recorded in the placebo group, while none were recorded in the vaccine group.
Due to the time required for the immune response to develop, in the first week after vaccination, there was no significant difference in protection against severe cases of COVID-19 between the vaccine and placebo groups, while in the period 7 to In 14 days, the efficacy of the vaccine rose to 50%, in the period from 14 to 21 days to 74.1%, and to 100% from day 21, providing total protection against severe cases of the coronavirus.
The study included 2,144 volunteers over 60 years of age with the maximum ages of 87 years (vaccine group) and 84 years (placebo group), showing excellent safety results for the elderly strata.
The efficacy of the vaccine for the elderly was demonstrated in 91.8% and does not differ statistically from the 18-60 age group, demonstrating immunogenicity – ability of an antigen to activate the immune system and induce an immune response – in this range age.
Sputnik V has demonstrated an excellent safety profile: 70 serious adverse events (SAE) episodes not related to COVID-19 were recorded in 68 study participants: in 45 volunteers from the vaccine group and 23 volunteers from the placebo group.
None of those events were associated with vaccination, as confirmed by the Committee’s independent data monitoring.
Most of the adverse effects (94%) were mild and limited to flu-like syndromes, injection site reactions, headache, and asthenia.
Sputnik V is one of only three vaccines globally that has shown more than 90% efficacy. It stands out among these vaccines thanks to several key advantages, namely: a well-studied and highly efficient human adenoviral vector mechanism proven safe for decades; the low cost of the vaccine compared to other approaches; and fewer logistical requirements with a storage temperature of between two and eight degrees Celsius, allowing for easier distribution around the world.
The safety of human adenovirus-based vaccines has been confirmed in more than 75 international publications and more than 250 clinical trials conducted over the past two decades, while the history of the use of human adenoviruses in vaccine development began in 1953.
Adenovirus vectors are genetically modified common flu viruses that cannot reproduce in a human body. When the Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so-called “spikes” that form its crown. This eliminates the possibility of becoming infected as a result of the vaccination and, at the same time causing the body to generate a stable immune response.
Furthermore, Sputnik V uses two different vectors, based on human adenovirus serotypes Ad5 and Ad26: in two separate shots, allowing for a more effective defense against coronavirus than vaccines that use the same vector for both injections.
Sputnik V avoids a possible neutralizing effect by implementing two different vectors and generates a more durable immune response.
The Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation is one of Russia’s oldest research centers, celebrating its centenary in 1991. The center’s research’s main focus is fundamental problems in epidemiology, medical and molecular microbiology, and infectious immunology.