The scientific objection behind the vaccine Sputnik V on the validation of the results of its Phase III reviewed by international peers, as required by the work of science, was settled as of the publication today of its complete 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 was 91.6 percent.
The scientific process advanced towards the correct box but Argentina 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 awaits the promised doses. Until today, for the local case, three shipments arrived by air; the first two with 300 thousand doses and shipment 3, with 220 thousand.
The announcement of the publication of the provisional results in The Lancet confirmed it to Infobae on Gamaleya National Research Center for 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, which is based on a well-studied human adenoviral vector platform, and 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 in the efficacy analysis (14,964 of those who 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 robust humoral and cell-mediated immune response,” they reported in a document to which Infobae agreed exclusively. The expectation was high, more in Argentina 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 strategy for the Americas of the Oxford-AstraZeneca vaccine.
Upon the news of the release of Sputnik V Phase III data in The Lancet, Infobae had exclusive access to the statements of international experts.
Hildegund C.J. Ertl, Professor at The Wistar Institute Center for Vaccines and Immunotherapy, United States, stated, “The vaccine is 100% effective in preventing serious diseases or deaths, 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 its part, Cecil Czerkinsky, PhD, Director of Research, National Institute of Health and Medical Research (Inserm), France, said: “The interim results of the 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 Argentine infectologist Omar Sued, President of the Society of Infectious Diseases of Argentina, he pointed out, “the article, published in The Lancet, confirms the successful results and provides additional information on the efficacy and safety of this vaccine in different subgroups. From a public health point of view, the efficacy of the vaccine was very high. The safety profile was very good. The dissemination of this information is vital to inform about the expansion and deployment of this vaccine around the world ”.
Alexander Gintsburg, director of the Gamaleya Research Institute of Epidemiology and Microbiology, stated: “The publication of international peer-reviewed data on the results of the 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 not only is Sputnik V the world’s first registered vaccine, but also 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 the only three vaccines in the world with an efficacy of more than 90% efficacy, but outperforms them in terms of safety, 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 results of the peer-reviewed study, 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 of 7 to 14 days the efficacy of the vaccine rose to 50% , in the period from 14 to 21 days at 74.1%, and at 100% from day 21, providing total protection against severe cases of the coronavirus.
As clarified in the document you accessed Infobae, 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 group of 18-60 years, also demonstrating results of immunogenicity -ability of an antigen to activate the immune system and induce an immune response- in this age group.
Sputnik V has demonstrated an excellent safety profile: 70 episodes of serious adverse events (SAEs) 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 these events were associated with vaccination as confirmed by the Committee’s independent data monitoring.. Most 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 in the world that has shown efficacy of more than 90%. It stands out among these vaccines thanks to a number of key benefits, including: a mechanism of vector adenoviral well studied and highly efficient human 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 made 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 completely 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.
Further, 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. By implementing two different vectors, Sputnik V avoids a possible neutralizing effect 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 the oldest research centers in Russia, which celebrated its centenary in 1991. The main focus of the center’s research is fundamental problems in epidemiology, medical and molecular microbiology, and infectious immunology.
Infographic: Marcelo Regalado
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