{"id":20880,"date":"2020-08-12T13:03:27","date_gmt":"2020-08-12T11:03:27","guid":{"rendered":"http:\/\/www.aldiplomasy.com\/en\/?p=20880"},"modified":"2020-08-12T13:03:27","modified_gmt":"2020-08-12T11:03:27","slug":"scientists-doubt-russian-coronavirus-vaccine-safty-and-effectiveness","status":"publish","type":"post","link":"https:\/\/www.aldiplomasy.com\/en\/?p=20880","title":{"rendered":"Scientists doubt Russian coronavirus vaccine safty and effectiveness!"},"content":{"rendered":"<div class=\"PageBuilder-containerFluidWidths PageBuilder-pageRow\">\n<div class=\"PageBuilder-col-9 PageBuilder-col PageBuilder-article\">\n<div id=\"RegularArticle-KeyPoints-4\" class=\"RenderKeyPoints-keyPoints\" data-test=\"keyPoints-1\" data-analytics=\"RegularArticle-keyPoints-4-1\">\n<div class=\"RenderKeyPoints-wrapper\">\n<div class=\"RenderKeyPoints-list\">\n<div>\n<div class=\"group\">\n<ul>\n<li style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><em><span style=\"color: #ff0000; text-decoration: underline;\">Scientists are skeptical about Putin\u2019s claims on Russia\u2019s potential Covid-19 vaccine, saying the vaccine still needs critical data to determine whether it\u2019s safe or effective.<\/span><\/em><\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><em><span style=\"color: #ff0000; text-decoration: underline;\">Developing, testing and reviewing any potential vaccine is a long, complex and expensive endeavor that typically takes months or even years.<\/span><\/em><\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><em><span style=\"color: #ff0000; text-decoration: underline;\">\u201cPhase three trials are critical\u201d for vaccine development, said Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health.<\/span><\/em><\/span><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div id=\"RegularArticle-ArticleBody-5\" class=\"ArticleBody-articleBody\" data-module=\"ArticleBody\" data-test=\"articleBody-2\" data-analytics=\"RegularArticle-articleBody-5-2\">\n<div class=\"group\" style=\"text-align: justify;\">\n<p>Scientists and public health officials are skeptical about\u00a0Russian President\u00a0<a href=\"https:\/\/www.cnbc.com\/id\/10000510\">Vladimir Putin<\/a>\u2019s\u00a0claim that the country\u2019s potential vaccine for the coronavirus \u201cworks quite effectively,\u201d saying Tuesday that the vaccine still needs critical testing to determine whether it\u2019s safe and effective.<\/p>\n<p>Hours earlier,\u00a0<a href=\"https:\/\/ria.ru\/20200811\/1575627527.html\" target=\"_blank\" rel=\"noopener noreferrer\">Putin said Russian health officials approved\u00a0<\/a>what he said is the first coronavirus vaccine in the world, adding that one of his daughters has already taken it. Clinical trials of the vaccine have been completed in less than two months and phase three trials are set to begin on Wednesday, even as Russia lays out plans for a \u201cmassive release\u201d to the public. Russian officials say they hope to soon start immunizing people with the vaccine, which, according to The Wall Street Journal, they\u2019ve dubbed Sputnik V, named for the world\u2019s first satellite, launched in 1957.<\/p>\n<div class=\"BoxInline-container  \">\n<div id=\"BoxInline-ArticleBody-5\" class=\"BoxInline-container\" data-module=\"mps-slot\"><\/div>\n<\/div>\n<p>\u201cAs far as I know, a vaccine against a new coronavirus infection has been registered this morning, for the first time in the world,\u201d Putin said at a meeting with members of the government,\u00a0<a href=\"https:\/\/ria.ru\/20200811\/1575627527.html\" target=\"_blank\" rel=\"noopener noreferrer\">RIA Novosti reported<\/a>. \u201cAlthough I know that it works quite effectively, it forms a stable immunity and, I repeat, has passed all the necessary checks,\u201d Putin said. Russia\u2019s health minister has previously said it plans to roll the vaccine out for public use in October, the Journal reported.<\/p>\n<\/div>\n<p class=\"ArticleBody-subtitle\" style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><em><span style=\"color: #ff0000; text-decoration: underline;\">Not confident\u00a0<\/span><\/em><\/span><\/p>\n<div class=\"group\" style=\"text-align: justify;\">\n<p>However, medical experts warn that without a large-scale phase three clinical trial, it\u2019s really unknown whether the vaccine even works and what potential side effects it could have on the general public.<\/p>\n<p>\u201cPhase three trials are critical\u201d for drug and vaccine development, said Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health. \u201cWould I be confident about the safety and effectiveness without a phase three? Absolutely not.\u201d<\/p>\n<p>Dr. Paul Offit, director of the Vaccine Education Center at Children\u2019s Hospital of Philadelphia, said he worries Russia\u2019s vaccine approval could pressure the U.S. to deploy a vaccine before it\u2019s ready.<\/p>\n<p>\u201cIt could be a major mistake. It could cause a lot of harm,\u201d he told CNBC\u2019s \u201cThe Exchange,\u201d adding Russia\u2019s move was a \u201cpolitical stunt.\u201d<\/p>\n<p>The World Health Organization has said there is no \u201csilver bullet\u201d for the coronavirus, which has infected more than 20 million people worldwide and killed at least 737,000 as of Tuesday, according to data compiled by Johns Hopkins University. Scientists across the globe are racing to develop a safe and effective vaccine for the virus in record time.<\/p>\n<div class=\"MidResponsive-midResponsiveContainer\">\n<div id=\"MidResponsive-4\" class=\"\" data-module=\"mps-slot\">\n<div id=\"div-gpt-midresponsive-2015156797\" class=\"mps-slot\" data-mps-slot=\"midresponsive\" data-mps-loadset=\"0\">There are more than 150 vaccines under development worldwide, including Russia\u2019s, according to the WHO, with 26 already in human trials.<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"ArticleBody-subtitle\" style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><em><span style=\"color: #ff0000; text-decoration: underline;\">Tough hurdles<\/span><\/em><\/span><\/p>\n<div class=\"group\" style=\"text-align: justify;\">\n<p>The vaccine also appears to face a tough hurdle winning approval from the WHO before the international health organization will buy or recommend it to other nations.<\/p>\n<p>\u201cYou cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages,\u201d Dr. Jarbas Barbosa, assistant director of WHO\u2019s\u00a0Pan American Health Organization, said at a press conference Tuesday.\u00a0\u201cCurrently WHO is in contact with the regulatory authorities in Russia in order to receive information on this vaccine and only after analyzing all of the information making it possible for WHO to make a recommendation.\u201d<\/p>\n<p>Developing, testing and reviewing any potential vaccine is a long, complex and expensive endeavor that typically takes months or even years. The fastest-ever vaccine development, for mumps, took more than four years before it was licensed in 1967.<\/p>\n<\/div>\n<p class=\"ArticleBody-subtitle\" style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><span style=\"color: #ff0000;\"><em>Effects on the human body<\/em><\/span><\/span><\/p>\n<div class=\"group\" style=\"text-align: justify;\">\n<p>Additionally, scientists caution that questions remain about the short- and long-term effects of the coronavirus on the human body. It was only discovered seven months ago and it hasn\u2019t been studied in depth, they say.<\/p>\n<p>To be sure, Russia has \u201cphenomenal\u201d scientists and is a powerhouse when it comes to many aspects of science, said\u00a0infectious disease specialist Isaac\u00a0Bogoch.\u00a0Although he has \u201cno doubts\u201d Russia can create a safe and effective vaccine, Bogoch said he was still skeptical.<\/p>\n<p>\u201cYou can\u2019t just start giving a vaccine to the public,\u201d said Bogoch, a professor at the\u00a0University of Toronto.<\/p>\n<p>Scientists at Moscow\u2019s Gamaleya Institute for Epidemiology and Microbiology used military-style testing, sped up clinical evaluations and took other measures to shorten the time needed to develop and review the vaccine, the Journal reported.<\/p>\n<\/div>\n<p class=\"ArticleBody-subtitle\" style=\"text-align: justify;\"><span style=\"text-decoration: underline;\"><span style=\"color: #ff0000;\"><em>Transparent data<\/em><\/span><\/span><\/p>\n<div class=\"group\" style=\"text-align: justify;\">\n<p>The shortened review also made U.S. Health and Human Services\u00a0Secretary\u00a0Alex Azar wary.<\/p>\n<p>\u201cWe need transparent data, and it\u2019s got to be phase three data that shows that a vaccine is safe and effective,\u201d he said\u00a0in an interview on ABC on Tuesday.\u00a0\u201cThe point is not to be first with a vaccine, the point is to have a vaccine that is safe and effective for the American people and the people of the world.\u201d<\/p>\n<p>Early stage trials are small, typically testing a drug or vaccine on 20 to 80 healthy volunteers. Phase three trials, which typically randomize who gets the vaccine and who doesn\u2019t, can have thousands of participants from different backgrounds and are needed to root out any potential side effects, medical experts say. Drug companies\u00a0<a href=\"https:\/\/www.cnbc.com\/quotes\/?symbol=PFE\">Pfizer<\/a>\u00a0and\u00a0<a href=\"https:\/\/www.cnbc.com\/quotes\/?symbol=MRNA\">Moderna<\/a>\u00a0last month both began late-stage trials for potential coronavirus vaccines, which are both expected to include up to 30,000 participants.<\/p>\n<\/div>\n<p class=\"ArticleBody-subtitle\" style=\"text-align: justify;\"><span style=\"text-decoration: underline; color: #ff0000;\"><em>Randomized trial needed<\/em><\/span><\/p>\n<div class=\"group\" style=\"text-align: justify;\">\n<p>\u201cThe randomization process is critical. There are things you do know, like underlying health status. But then there are things that you don\u2019t know that could be a factor, like genetics,\u201d Salmon said. \u201cWhen you randomize the process, it takes care of that. You have a really good comparison group.\u201d<\/p>\n<p>\u201cIf five people have a heart attack in one group, you can compare it to the other group,\u201d he added.\u00a0\u201cOnce a vaccine is licensed and used, it\u2019s harder to study because it\u2019s not randomized.\u201d<\/p>\n<p>Dr. Scott Gottlieb, a former U.S. Food and Drug Administration commissioner, urged caution about Russia\u2019s coronavirus vaccine, telling CNBC on Tuesday he would \u201ccertainly not\u201d take it outside of a clinical trial where patients are closely monitored.<\/p>\n<\/div>\n<p class=\"ArticleBody-subtitle\" style=\"text-align: justify;\"><em><span style=\"text-decoration: underline;\"><span style=\"color: #ff0000; text-decoration: underline;\">Questions about safety<\/span><\/span><\/em><\/p>\n<div class=\"group\">\n<p style=\"text-align: justify;\">\u201cThey\u2019re claiming that it\u2019s fully approved, but it\u2019s not fully approved,\u201d said Gottlieb, who also sits on Pfizer\u2019s board.<\/p>\n<p style=\"text-align: justify;\">Researchers have yet to publish any data on the vaccine trials thus far, including information on the safety, efficacy or possible long-term side effects. Gottlieb said that wouldn\u2019t fly with American regulators.<\/p>\n<p style=\"text-align: justify;\">\u201cWe certainly wouldn\u2019t allow a vaccine to be used for mass distribution at this point based on the data we have at hand,\u201d he said. \u201cWe just don\u2019t know if the vaccines are safe and effective at this point.\u201d<\/p>\n<p style=\"text-align: justify;\">Russia\u2019s sovereign wealth fund, the\u00a0Russian Direct Investment Fund, said Tuesday that it\u2019s backing the\u00a0production of the vaccine for sale in foreign markets.\u00a0It said there had been \u201cconsiderable interest\u201d from abroad.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Scientists are skeptical about Putin\u2019s claims on Russia\u2019s potential Covid-19 vaccine, saying the vaccine still needs critical data to determine whether it\u2019s safe or effective. Developing, testing and reviewing any potential vaccine is a long, complex and expensive endeavor that typically takes months or even years. \u201cPhase three trials are critical\u201d for vaccine development, said &hellip;<\/p>\n","protected":false},"author":1,"featured_media":20882,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4220,388],"tags":[],"class_list":["post-20880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-economy","category-slide"],"_links":{"self":[{"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/posts\/20880","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20880"}],"version-history":[{"count":1,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/posts\/20880\/revisions"}],"predecessor-version":[{"id":20883,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/posts\/20880\/revisions\/20883"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=\/wp\/v2\/media\/20882"}],"wp:attachment":[{"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20880"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20880"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.aldiplomasy.com\/en\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20880"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}