{"id":225974,"date":"2020-08-13T15:39:49","date_gmt":"2020-08-13T19:39:49","guid":{"rendered":"https:\/\/oncubanews.com\/en\/?p=225974"},"modified":"2020-08-13T15:39:49","modified_gmt":"2020-08-13T19:39:49","slug":"the-russian-sputnik-v-vaccine","status":"publish","type":"post","link":"https:\/\/oncubanews.com\/en\/opinion\/the-russian-sputnik-v-vaccine\/","title":{"rendered":"The Russian Sputnik V vaccine"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">On Tuesday, August 11th, Russian President Vladimir Putin announced that his country had registered the first vaccine against the coronavirus that causes the current <a href=\"https:\/\/oncubanews.com\/tag\/coronavirus\/\" target=\"_blank\" rel=\"noopener noreferrer\">COVID-19<\/a> pandemic.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Undoubtedly it could be very encouraging news for the world, something that we have all been waiting for since March 11th, 2020, when the World Health Organization (WHO) declared that we were facing a new pandemic; and the world turned upside down.<\/span><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"WFvy6N2YLH\"><p><a href=\"https:\/\/oncubanews.com\/coronavirus\/rusia-comenzaria-en-octubre-campana-de-vacunacion-contra-la-covid-19\/\">Rusia comenzar\u00eda en octubre campa\u00f1a de vacunaci\u00f3n contra la COVID-19<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"\u00abRusia comenzar\u00eda en octubre campa\u00f1a de vacunaci\u00f3n contra la COVID-19\u00bb \u2014 OnCubaNews\" src=\"https:\/\/oncubanews.com\/coronavirus\/rusia-comenzaria-en-octubre-campana-de-vacunacion-contra-la-covid-19\/embed\/#?secret=RhOH9OOttZ#?secret=WFvy6N2YLH\" data-secret=\"WFvy6N2YLH\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<p><span style=\"font-weight: 400;\">So, why has this news been taken with caution by the scientific community? Beyond geopolitical interests (which unfortunately exist), the problem is what is known and what is yet unknown about the vaccine with trade name \u201cSputnik V\u201d, the same name as the first satellite that the Soviet Union managed to put into orbit in space, in one of its greatest victories in the technological race with the United States during the Cold War. Sputnik translates as \u201csatellite\u201d, but it is also a word that derives from the Greek and means \u201ctraveling companion\u201d.<\/span><\/p>\n<p><b>What do we know about the Russian vaccine?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The Gam-COVID-Vac vaccine was developed by scientists from the National Research Center for Epidemiology and Microbiology (Gamaleya) together with the Ministry of Defense. It is based on an adenovirus that carries a gene that encodes a protein of the new coronavirus and that, apparently, generates protective immunity.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Russian Health Minister Mikhail Murashko <a href=\"https:\/\/mundo.sputniknews.com\/rusia\/202008111092378358-putin-anuncia-el-registro-en-rusia-de-la-primera-vacuna-contra-el-covid-19\/?fbclid=IwAR0p5aMa3gNPKE8topwqJ55ry6KL6-mmz37hrMHCXfOEH7hSgSzMOY2mcVo\" target=\"_blank\" rel=\"noopener noreferrer\">stated<\/a> that the Gamaleya vaccine showed its high efficacy and safety in the carried out clinical trials. &#8220;All the volunteers who received the vaccine developed antibodies and none of them showed serious complications&#8221;, he stated.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">On August 3, the Russian Defense Ministry <a href=\"https:\/\/mundo.sputniknews.com\/rusia\/202008031092293365-misterio-de-defensa-vacuna-rusa-genera-inmunidad-contra-covid-19\/\" target=\"_blank\" rel=\"noopener noreferrer\">reported<\/a> that two groups of volunteer military personnel who received the vaccine (no more than 100 people) had developed protective immunity to the SARS-Cov-2 coronavirus.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The Ministry of Health <a href=\"https:\/\/mundo.sputniknews.com\/rusia\/202008111092378358-putin-anuncia-el-registro-en-rusia-de-la-primera-vacuna-contra-el-covid-19\/?fbclid=IwAR0p5aMa3gNPKE8topwqJ55ry6KL6-mmz37hrMHCXfOEH7hSgSzMOY2mcVo\" target=\"_blank\" rel=\"noopener noreferrer\">stated<\/a> that the Russian vaccine against COVID-19 guarantees immunity for up to 2 years. \u201cThe double injection scheme makes it possible to generate long-lasting immunity. The experience of the use of vector vaccines (with the use of the double injection scheme) shows that immunity will be preserved for up to two years\u201d, says the statement.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to data from the State Drug Registry of the Russian Ministry of Health, the vaccine would begin to circulate on January 1st, 2021.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Analyzing these statements it is inferred that the Russian vaccine candidate could have concluded phase I of the clinical trials (these are the only data that appear on the official WHO website), and perhaps phase II (although the results have not been published and registered by WHO yet); but not phase III, which would include thousands of people. In this regard, the Russian health minister indicated that it is part of the process that the Gam-COVID-Vac (Sputnik V) vaccine, already registered, must follow.<\/span><\/p>\n<p><b>What are the main concerns with the Russian vaccine?<\/b><\/p>\n<ul style=\"list-style-type: square;\">\n<li><span style=\"font-weight: 400;\">So far, Russian scientists have not published a detailed study of the results of their trials that allow the establishment of the vaccine\u2019s efficacy. The WHO has only published as a reference two articles showing the results of clinical trials during phase I <strong>\u00b9<\/strong>.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">According to the statement issued this Tuesday by the Russian Ministry of Health, this vaccine &#8220;passed all the necessary safety and efficacy tests in different types of animals (rodents and primates)&#8221; before being tested in two groups of 38 volunteers each. Therefore, it is inferred that the vaccine candidate has not passed phase III of clinical trials. There are not a few vaccine candidates that stay in this phase because they do not pass the controls that the phase implies, and they do not manage to be commercialized.<\/span><\/li>\n<\/ul>\n<p><b>What process does a vaccine candidate have to follow until it is approved for use in humans?<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The World Health Organization establishes a protocol that many governments and regulatory institutions around the world follow, although each has specific regulations.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ensuring that vaccines are safe, effective, and of quality, is a critical element in their development and distribution. It begins with the first stages of the vaccine, usually in the laboratory, where its components are subjected to tests to determine aspects such as purity and power. This is followed by clinical trials consisting of three phases.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The license, or authorization for use in humans, is the fundamental step of the process. The official entity that grants the authorization, the national regulatory body, is the one who determines if the standards established to guarantee the quality of the vaccine have been met.<\/span><\/p>\n<p>What are the <a href=\"https:\/\/www.historyofvaccines.org\/es\/contenido\/articulos\/desarrollo-pruebas-y-reglamentos-para-las-vacunas\" target=\"_blank\" rel=\"noopener noreferrer\">steps<\/a> to follow?<\/p>\n<p><strong>Exploration stage<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">This stage involves basic laboratory research, and often lasts 2 &#8211; 4 years.<\/span><\/p>\n<p><strong>Preclinical stage<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Preclinical studies use tissue culture systems or cell culture, and animal tests to evaluate the safety of the candidate vaccine and its ability to generate an immune response.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Researchers can tailor the candidate vaccine during the preclinical phase to try to make it more effective. They can also conduct exposure studies on animals, which means that they vaccinate the animals and then try to infect them with the target pathogen. These kinds of studies are never carried out in humans.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Many candidate vaccines do not pass beyond this stage, as they cannot generate the desired immune response. The preclinical stages often last 1 to 2 years.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To continue the studies, after completing this phase, an application must have been approved by a competent agency.<\/span><\/p>\n<p><b>Human clinical studies<\/b><\/p>\n<p><strong>Phase I<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">This first attempt to evaluate the candidate vaccine in humans involves a small group of adults, usually between 20 to 80. If the vaccine is aimed at children, the researchers will test adults first, gradually reducing the age of the tested subjects until they reach the target age. The goals of phase I testing are to evaluate the safety of the candidate vaccine and to determine the type and extent of the immune response elicited by the vaccine.<\/span><\/p>\n<p><strong>Phase II<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">A larger group of several hundred people participate in Phase II trials. Some of the people may belong to groups at risk of contracting the disease; the trials are randomized and well-controlled and include a placebo group. The goals of phase II trials are to study the candidate vaccine for safety, immunogenicity, proposed doses, vaccination schedule, and administration method.<\/span><\/p>\n<p><strong>Phase III<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">Candidate vaccines that are successful in phase II advance to larger trials, involving thousands to tens of thousands of people. Phase III trials are randomized and double-blind; they involve the experimental vaccine that is tested against a placebo (the placebo can be a saline solution, a vaccine for another disease, or some other substance). One goal of phase III is to evaluate the safety of the vaccine in a large group of people. Some unusual side effects may not be apparent in smaller groups of people who were part of the earlier phases.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">During these phases, the efficacy of the vaccine to protect against the disease is evaluated. Antibody production tests and immunological response tests are conducted on the people who receive the vaccine. After a phase III trial is concluded successfully, accredited agencies will inspect the product, factories, and research results until they issue the approval.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">After being approved for large-scale use, the vaccines continue to be monitored.<\/span><\/p>\n<p><b>Race for a COVID-19 vaccine<\/b><\/p>\n<p><span style=\"font-weight: 400;\">In this race for humans health, all the vaccine candidates have been worked in record time. Suffice it to say that the average time to achieve a successful vaccine is between <a href=\"https:\/\/www.historyofvaccines.org\/es\/contenido\/articulos\/desarrollo-pruebas-y-reglamentos-para-las-vacunas\" target=\"_blank\" rel=\"noopener noreferrer\">10 and 15 years<\/a>. In the 20th century and what we have lived from the 21st, a vaccine developed in five years was considered an exceptional achievement.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The effort of the scientific community to find a vaccine is unprecedented, and great resources have been allocated to it. But <a href=\"https:\/\/www.pagina12.com.ar\/284345-que-dijo-la-oms-sobre-la-vacuna-de-rusia-contra-el-coronavir\" target=\"_blank\" rel=\"noopener noreferrer\">according to<\/a> Tarik Jasarevic, WHO spokesman, &#8220;accelerating progress should not mean compromising safety.&#8221;<\/span><\/p>\n<figure id=\"attachment_225977\" aria-describedby=\"caption-attachment-225977\" style=\"width: 640px\" class=\"wp-caption aligncenter\"><a href=\"https:\/\/oncubanews.com\/en\/wp-content\/uploads\/2020\/08\/113564253_vaccines_development_640_spanish-nc-1-1.png\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-225977\" src=\"https:\/\/oncubanews.com\/en\/wp-content\/uploads\/2020\/08\/113564253_vaccines_development_640_spanish-nc-1-1.png\" alt=\"\" width=\"640\" height=\"867\" srcset=\"https:\/\/oncubanews.com\/en\/wp-content\/uploads\/2020\/08\/113564253_vaccines_development_640_spanish-nc-1-1.png 640w, https:\/\/oncubanews.com\/en\/wp-content\/uploads\/2020\/08\/113564253_vaccines_development_640_spanish-nc-1-1-221x300.png 221w\" sizes=\"auto, (max-width: 640px) 100vw, 640px\" \/><\/a><figcaption id=\"caption-attachment-225977\" class=\"wp-caption-text\">Source: BBC<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">At the moment, about 26 possible vaccines are being tested in different phases, of which six are in phase III (final) of clinical trials.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Three of these six vaccines are developed in China, while the others are being studied in the laboratories of the American pharmaceutical companies Pfizer, Moderna, and the British AstraZeneca, the latter in collaboration with the University of Oxford.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">President Putin assured that the mass production of Sputnik V would begin shortly and that it would begin to be available for doctors and teachers in the first place towards the end of August or the beginning of September, while the rest of the citizens could access it in January of 2021. One of the Russian president&#8217;s daughters <a href=\"https:\/\/mundo.sputniknews.com\/rusia\/202008111092378429-putin-afirma-que-su-hija-se-puso-la-vacuna-contra-el-coronavirus\/\" target=\"_blank\" rel=\"noopener noreferrer\">has been reported<\/a> to be part of the first group of volunteers. For his part, the head of the Russian Direct Investment Fund, Kiril Dm\u00edtriev, declared that Cuba could begin to produce the Russian vaccine in November, although the Cuban authorities have not yet ruled on the matter, even though yesterday, August 12, the <\/span><i><span style=\"font-weight: 400;\">Mesa Redonda<\/span><\/i><span style=\"font-weight: 400;\"> TV program in Cuba was dedicated to &#8220;Cuban science against COVID-19&#8221;. Brazil and Nicaragua <a href=\"https:\/\/www.bbc.com\/mundo\/noticias-internacional-53745100\" target=\"_blank\" rel=\"noopener noreferrer\">could also start producing it<\/a> in the region.<\/span><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"Rnq5niDZi0\"><p><a href=\"https:\/\/oncubanews.com\/en\/cuba\/cuba-could-produce-russian-covid-19-vaccine\/\">Cuba could produce Russian COVID-19 vaccine<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Cuba could produce Russian COVID-19 vaccine&#8221; &#8212; OnCubaNews English\" src=\"https:\/\/oncubanews.com\/en\/cuba\/cuba-could-produce-russian-covid-19-vaccine\/embed\/#?secret=humRS9ZKtu#?secret=Rnq5niDZi0\" data-secret=\"Rnq5niDZi0\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<p><span style=\"font-weight: 400;\">The WHO spokesman clarified that, like the other vaccines that are currently being developed in various countries, the Russian one must comply with the prequalification and review procedures established by the organization.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cWe are in close contact with the Russians and discussions continue. The prequalification of all vaccines goes through rigorous procedures&#8221;, Jasarevic pointed out during a press video-conference.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;Prequalification comprises the examination and evacuation of all the required safety and efficacy elements collected during clinical trials\u201d, the WHO spokesperson remarked.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The famous doctor Francisco Dur\u00e1n, director of Epidemiology of the Ministry of Public Health of Cuba, the most visible face of this fight against COVID-19 on the Island, said yesterday, August 12, in the usual press conference broadcasted on Cuban television: \u201cThe first one who is going to be happy that a solution appears would be me\u201d, but he clarified that so far what we have is prevention; \u201cI don&#8217;t think there will be a vaccine available in the world probably until the first months of the year 2021, despite all the efforts of science\u201d.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The truth is that, although it is a hopeful result, we will not know if the Russian vaccine is safe until it concludes phase III of the clinical trial; and it will not be able to advance to a mass vaccination scheme if the regulatory bodies do not approve it. For that, of course, I cross all my fingers.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">When women and men of science have found an effective and safe vaccine against COVID-19, they will have broken all records, they will have saved us. But they do not do magic; to achieve that, it requires a lot of work and steps that can be accelerated, but not violated.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Hopefully, the Russian vaccine, the Chinese ones, the American ones, all of them work as soon as possible; and hopefully the scientific community, governments, companies\u2026 agree to make them accessible to all. It will have been a feat of science, and humanity.<\/span><\/p>\n<p><em><strong>*Note:<\/strong><\/em><\/p>\n<p><sup><strong>\u00a0<\/strong><\/sup><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04436471?term=vaccine&amp;cond=covid-19&amp;draw=4\">An Open Study of the Safety, Tolerability and Immunogenicity of the Drug \u00abGam-COVID-Vac\u00bb Vaccine Against COVID-19<\/a>.<\/p>\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04437875?term=vaccine&amp;cond=covid-19&amp;draw=4\">\u00a0 An Open Study of the Safety, Tolerability and Immunogenicity of \u00abGam-COVID-Vac Lyo\u00bb Vaccine Against COVID-19<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On Tuesday, August 11th, Russian President Vladimir Putin announced that his country had registered the first vaccine against the coronavirus that causes the current COVID-19 pandemic. Undoubtedly it could be very encouraging news for the world, something that we have all been waiting for since March 11th, 2020, when the World Health Organization (WHO) declared [&hellip;]<\/p>\n","protected":false},"author":102,"featured_media":225975,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[14135],"tags":[28545,32668],"ppma_author":[33570,31139],"class_list":["post-225974","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-opinion","tag-coronavirus","tag-covid-19-vaccine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The Russian Sputnik V vaccine | OnCubaNews English<\/title>\n<meta name=\"description\" content=\"Although it is a hopeful result, we will not know if the vaccine is safe or not until phase III of the clinical 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