MetalGuru
2021-10-15
Just had my booster shot today ! Support Moderna !
Moderna shares jumped 3% in premarket trading<blockquote>Moderna股价在盘前交易中上涨3%</blockquote>
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Support Moderna !","highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/824148087","repostId":1102010434,"repostType":4,"repost":{"id":"1102010434","kind":"news","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1634291128,"share":"https://www.laohu8.com/m/news/1102010434?lang=zh_CN&edition=full","pubTime":"2021-10-15 17:45","market":"us","language":"en","title":"Moderna shares jumped 3% in premarket trading<blockquote>Moderna股价在盘前交易中上涨3%</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1102010434","media":"Tiger Newspress","summary":"Moderna shares jumped 3% in premarket trading as Moderna booster shot backed by FDA advisory panel.\n","content":"<p>Moderna shares jumped 3% in premarket trading as Moderna booster shot backed by FDA advisory panel.</p><p><blockquote>由于Moderna得到FDA顾问小组的支持，Moderna股价在盘前交易中上涨3%。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/ccd4997364ec9441dc27498c64730e44\" tg-width=\"850\" tg-height=\"616\" width=\"100%\" height=\"auto\"></p><p><blockquote></blockquote></p><p> Vaccine experts advising the Food and Drug Administration voted 19 to 0 Thursday to recommend authorization of an extra dose of Moderna Inc.’s Covid-19 shot, a key step in making booster doses available to millions more people.</p><p><blockquote>美国食品和药物管理局的疫苗专家周四投票19日至0日建议批准Moderna Inc.的新冠肺炎疫苗接种，这是向数百万人提供加强剂的关键一步。</blockquote></p><p> A vaccine-advisory panel voted in favor of giving a Moderna booster shot at least six months after the second dose, to adults 65 years and older, as well as adults under 65 who are at high risk of severe Covid-19 or serious complications because of their jobs, living conditions or underlying medical conditions.</p><p><blockquote>一个疫苗咨询小组投票赞成在第二剂疫苗后至少六个月为65岁及以上的成年人以及65岁以下因工作、生活条件或潜在医疗条件而面临严重Covid-19或严重并发症高风险的成年人注射Moderna加强针。</blockquote></p><p> The panel voted in favor of a booster shot that is half the dosage of the first two doses. The FDA is expected to decide on whether to authorize the booster dose within days.</p><p><blockquote>该小组投票赞成加强注射，剂量是前两剂的一半。FDA预计将在几天内决定是否批准加强剂量。</blockquote></p><p> Moderna said the booster doses can be drawn from the same vials that contain the original two-dose vaccine series, meaning the boosters will be available soon after authorization.</p><p><blockquote>Moderna表示，加强剂量可以从包含原始两剂疫苗系列的相同小瓶中提取，这意味着加强剂量将在获得授权后很快上市。</blockquote></p><p> Members of the FDA’s vaccine-advisory panel supported Moderna’s booster dose even though the evidence for it was from a small study and had mixed results.</p><p><blockquote>FDA疫苗咨询小组的成员支持Moderna的加强剂量，尽管其证据来自一项小型研究，并且结果好坏参半。</blockquote></p><p> “It’s more a gut feeling rather than based on really truly serious data,” said Patrick Moore, a member of the committee and a professor of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. “The data itself is not strong, but it is certainly going in the direction that is supportive of this vote.”</p><p><blockquote>“这更多的是一种直觉，而不是基于真正严肃的数据，”委员会成员、匹兹堡大学医学院分子遗传学和生物化学教授帕特里克·摩尔说。“数据本身并不强劲，但肯定是朝着支持这次投票的方向发展。”</blockquote></p><p> The meeting is a regular part of the federal government’s evaluation of the vaccines and the latest move toward authorizing Covid-19 boosters. The FDA often asks its expert advisers to share their views before the agency decides whether to clear a medicine, and the agency usually follows the advisers’ recommendations.</p><p><blockquote>这次会议是联邦政府评估疫苗的常规部分，也是授权新冠肺炎加强剂的最新举措。在该机构决定是否批准一种药物之前，FDA经常要求其专家顾问分享他们的观点，该机构通常会遵循顾问的建议。</blockquote></p><p> After clearing Covid-19 vaccines for adults starting late last year, the FDA has been in recent months evaluating applications to expand use of the shots to younger ages and to add an extra dose to bolster vaccinated people’s immune defenses, especially against the Delta variant.</p><p><blockquote>在去年年底开始批准成人Covid-19疫苗后，FDA近几个月一直在评估将疫苗使用范围扩大到更年轻人群的申请，并增加额外剂量以增强接种疫苗者的免疫防御，特别是针对德尔塔变异毒株的免疫防御。</blockquote></p><p> The FDA has authorized the vaccine from Pfizer Inc.and partner BioNTech SE for adolescents. The agency also has already greenlighted booster doses of the Pfizer-BioNTech vaccine for seniors and adults at high risk of Covid-19 who received the shots already and are at least six months past their first vaccination.</p><p><blockquote>FDA已批准辉瑞公司及其合作伙伴BioNTech SE的青少年疫苗。该机构还批准了辉瑞-BioNTech疫苗的加强剂量，用于已经接种疫苗且距离首次接种疫苗至少六个月的老年人和新冠肺炎高危成年人。</blockquote></p><p> It also has authorized boosters of the Pfizer-BioNTech and Moderna vaccines forcertain people with weakened immune systems.</p><p><blockquote>它还授权为某些免疫系统较弱的人提供辉瑞-BioNTech和Moderna疫苗的加强剂。</blockquote></p><p> A Centers for Disease Control and Prevention advisory panel is scheduled to meet Oct. 20 to weigh endorsing an additional Moderna dose, before it becomes available to the general public. The CDC doesn’t have to accept the panel’s recommendation but usually does.</p><p><blockquote>疾病控制和预防中心咨询小组计划于10月20日召开会议，在向公众提供额外的Moderna剂量之前权衡是否批准。疾病预防控制中心不必接受该小组的建议，但通常会接受。</blockquote></p><p> The meeting of the FDA panel, called the Vaccines and Related Biological Products Advisory Committee, comes as Covid-19 cases caused by the contagious Delta variant drop from highs in many parts of the country, though they are increasing in some states.</p><p><blockquote>FDA名为疫苗和相关生物制品咨询委员会的小组召开会议之际，由传染性德尔塔变异毒株引起的Covid-19病例在美国许多地区从高位下降，尽管在一些州正在增加。</blockquote></p><p> Federal health officials have pushed for boosters to sustain the immune protection in people who have been previously vaccinated, especially against Delta.</p><p><blockquote>联邦卫生官员一直在推动加强剂，以维持以前接种过疫苗的人的免疫保护，特别是针对Delta的疫苗。</blockquote></p><p> Up to 60 million people will become eligible for Pfizer’s booster shot in the coming weeks, the Biden administration has said.</p><p><blockquote>拜登政府表示，未来几周将有多达6000万人有资格接受辉瑞的加强注射。</blockquote></p><p> Adding Moderna’s additional shot would significantly expand the U.S. booster campaign. More than 69 million people in the U.S. are fully vaccinated with Moderna’s shot, according to the CDC.</p><p><blockquote>增加Moderna的额外注射将显着扩大美国的加强运动。据CDC称，美国有超过6900万人完全接种了Moderna疫苗。</blockquote></p><p> Moderna has asked the FDA to authorize a booster that is half the dosage of the first two vaccine doses, and is taken at least six months after the second dose.</p><p><blockquote>Moderna已要求FDA批准前两剂疫苗剂量一半的加强剂，并在第二剂疫苗接种后至少六个月服用。</blockquote></p><p> The booster shot increased immune responses in about 170 people in a Moderna study. The booster’s effect on immune responses met one goal in the study but fell slightly short on another goal, FDA staff said.</p><p><blockquote>在Moderna的一项研究中，加强注射增强了约170人的免疫反应。FDA工作人员表示，加强剂对免疫反应的影响达到了研究中的一个目标，但略低于另一个目标。</blockquote></p><p> Some members of the advisory panel expressed concern about the small size of the study, saying it limited their ability to assess the safety of the booster shots. The FDA said the safety profile of the booster was largely consistent with the first two doses.</p><p><blockquote>顾问小组的一些成员对这项研究的规模较小表示担忧，称这限制了他们评估加强注射安全性的能力。FDA表示，加强剂的安全性与前两剂基本一致。</blockquote></p><p> The panel also began to debate whether to make booster doses more widely available beyond the categories currently authorized, which include seniors and adults at high risk because of medical conditions or where they work.</p><p><blockquote>该小组还开始讨论是否在目前授权的类别之外更广泛地提供加强剂量，其中包括因医疗条件或工作地点而处于高风险的老年人和成年人。</blockquote></p><p> Some members said they were skeptical about the need to give an extra dose to everyone who was vaccinated because the shots appear to be working well and offer lasting protection for younger people.</p><p><blockquote>一些成员表示，他们怀疑是否有必要给每个接种疫苗的人额外注射一剂疫苗，因为疫苗似乎效果良好，并为年轻人提供持久的保护。</blockquote></p><p></p><p> “I don’t necessarily see the need for a sort of let it rip campaign for boosters for everyone who has ever been vaccinated,” said Michael Kurilla, director of clinical innovation at the National Center for Advancing Translational Sciences at the National Institutes of Health.</p><p><blockquote>美国国立卫生研究院国家转化科学促进中心临床创新主任迈克尔·库里拉(Michael Kurilla)表示：“我不一定认为有必要为每个接种过疫苗的人开展一场让它撕裂的活动。”</blockquote></p><p> Peter Marks, director of the FDA’s center for biologics evaluation and research, said the U.S. sees booster doses as a potentially important part of its strategy to mitigate cases heading into the winter.</p><p><blockquote>FDA生物制品评估和研究中心主任彼得·马克斯表示，美国认为加强剂量是其缓解冬季病例战略的潜在重要组成部分。</blockquote></p><p> “The problem here is we don’t know what we don’t know,” he said. “There are models that predict that we could potentially have another wave of Covid-19 as people go inside this winter.”</p><p><blockquote>“这里的问题是我们不知道我们不知道什么，”他说。“有模型预测，随着人们今年冬天进入室内，我们可能会出现另一波Covid-19。”</blockquote></p><p> The advisory panel will meet again on Friday to considerJohnson & Johnson’s application for a second dose and to review data on mixing and matching vaccines and boosters.</p><p><blockquote>顾问小组将于周五再次开会，考虑强生公司的第二剂申请，并审查混合和匹配疫苗和加强剂的数据。</blockquote></p><p> Covid-19 vaccines from Moderna and J&J are authorized for use in people 18 years and older, while the Pfizer-BioNTech vaccine is cleared for people 12 years and over.</p><p><blockquote>Moderna和J&J的新冠肺炎疫苗被授权用于18岁及以上的人群，而辉瑞-BioNTech疫苗被批准用于12岁及以上的人群。</blockquote></p><p> Outside the U.S., Israel, the U.K. and the European Medicines Agency have cleared use of boosters, and many countries have been rolling out the shots. The World Health Organization, however, has encouraged rich nations to delay booster campaigns and send doses to countries with limited supplies.</p><p><blockquote>在美国以外，以色列、英国和欧洲药品管理局已批准使用加强针，许多国家也已推出疫苗。然而，世界卫生组织鼓励富裕国家推迟加强疫苗接种活动，并向供应有限的国家发送疫苗。</blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Moderna shares jumped 3% in premarket trading<blockquote>Moderna股价在盘前交易中上涨3%</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nModerna shares jumped 3% in premarket trading<blockquote>Moderna股价在盘前交易中上涨3%</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time smaller\">2021-10-15 17:45</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Moderna shares jumped 3% in premarket trading as Moderna booster shot backed by FDA advisory panel.</p><p><blockquote>由于Moderna得到FDA顾问小组的支持，Moderna股价在盘前交易中上涨3%。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/ccd4997364ec9441dc27498c64730e44\" tg-width=\"850\" tg-height=\"616\" width=\"100%\" height=\"auto\"></p><p><blockquote></blockquote></p><p> Vaccine experts advising the Food and Drug Administration voted 19 to 0 Thursday to recommend authorization of an extra dose of Moderna Inc.’s Covid-19 shot, a key step in making booster doses available to millions more people.</p><p><blockquote>美国食品和药物管理局的疫苗专家周四投票19日至0日建议批准Moderna Inc.的新冠肺炎疫苗接种，这是向数百万人提供加强剂的关键一步。</blockquote></p><p> A vaccine-advisory panel voted in favor of giving a Moderna booster shot at least six months after the second dose, to adults 65 years and older, as well as adults under 65 who are at high risk of severe Covid-19 or serious complications because of their jobs, living conditions or underlying medical conditions.</p><p><blockquote>一个疫苗咨询小组投票赞成在第二剂疫苗后至少六个月为65岁及以上的成年人以及65岁以下因工作、生活条件或潜在医疗条件而面临严重Covid-19或严重并发症高风险的成年人注射Moderna加强针。</blockquote></p><p> The panel voted in favor of a booster shot that is half the dosage of the first two doses. The FDA is expected to decide on whether to authorize the booster dose within days.</p><p><blockquote>该小组投票赞成加强注射，剂量是前两剂的一半。FDA预计将在几天内决定是否批准加强剂量。</blockquote></p><p> Moderna said the booster doses can be drawn from the same vials that contain the original two-dose vaccine series, meaning the boosters will be available soon after authorization.</p><p><blockquote>Moderna表示，加强剂量可以从包含原始两剂疫苗系列的相同小瓶中提取，这意味着加强剂量将在获得授权后很快上市。</blockquote></p><p> Members of the FDA’s vaccine-advisory panel supported Moderna’s booster dose even though the evidence for it was from a small study and had mixed results.</p><p><blockquote>FDA疫苗咨询小组的成员支持Moderna的加强剂量，尽管其证据来自一项小型研究，并且结果好坏参半。</blockquote></p><p> “It’s more a gut feeling rather than based on really truly serious data,” said Patrick Moore, a member of the committee and a professor of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. “The data itself is not strong, but it is certainly going in the direction that is supportive of this vote.”</p><p><blockquote>“这更多的是一种直觉，而不是基于真正严肃的数据，”委员会成员、匹兹堡大学医学院分子遗传学和生物化学教授帕特里克·摩尔说。“数据本身并不强劲，但肯定是朝着支持这次投票的方向发展。”</blockquote></p><p> The meeting is a regular part of the federal government’s evaluation of the vaccines and the latest move toward authorizing Covid-19 boosters. The FDA often asks its expert advisers to share their views before the agency decides whether to clear a medicine, and the agency usually follows the advisers’ recommendations.</p><p><blockquote>这次会议是联邦政府评估疫苗的常规部分，也是授权新冠肺炎加强剂的最新举措。在该机构决定是否批准一种药物之前，FDA经常要求其专家顾问分享他们的观点，该机构通常会遵循顾问的建议。</blockquote></p><p> After clearing Covid-19 vaccines for adults starting late last year, the FDA has been in recent months evaluating applications to expand use of the shots to younger ages and to add an extra dose to bolster vaccinated people’s immune defenses, especially against the Delta variant.</p><p><blockquote>在去年年底开始批准成人Covid-19疫苗后，FDA近几个月一直在评估将疫苗使用范围扩大到更年轻人群的申请，并增加额外剂量以增强接种疫苗者的免疫防御，特别是针对德尔塔变异毒株的免疫防御。</blockquote></p><p> The FDA has authorized the vaccine from Pfizer Inc.and partner BioNTech SE for adolescents. The agency also has already greenlighted booster doses of the Pfizer-BioNTech vaccine for seniors and adults at high risk of Covid-19 who received the shots already and are at least six months past their first vaccination.</p><p><blockquote>FDA已批准辉瑞公司及其合作伙伴BioNTech SE的青少年疫苗。该机构还批准了辉瑞-BioNTech疫苗的加强剂量，用于已经接种疫苗且距离首次接种疫苗至少六个月的老年人和新冠肺炎高危成年人。</blockquote></p><p> It also has authorized boosters of the Pfizer-BioNTech and Moderna vaccines forcertain people with weakened immune systems.</p><p><blockquote>它还授权为某些免疫系统较弱的人提供辉瑞-BioNTech和Moderna疫苗的加强剂。</blockquote></p><p> A Centers for Disease Control and Prevention advisory panel is scheduled to meet Oct. 20 to weigh endorsing an additional Moderna dose, before it becomes available to the general public. The CDC doesn’t have to accept the panel’s recommendation but usually does.</p><p><blockquote>疾病控制和预防中心咨询小组计划于10月20日召开会议，在向公众提供额外的Moderna剂量之前权衡是否批准。疾病预防控制中心不必接受该小组的建议，但通常会接受。</blockquote></p><p> The meeting of the FDA panel, called the Vaccines and Related Biological Products Advisory Committee, comes as Covid-19 cases caused by the contagious Delta variant drop from highs in many parts of the country, though they are increasing in some states.</p><p><blockquote>FDA名为疫苗和相关生物制品咨询委员会的小组召开会议之际，由传染性德尔塔变异毒株引起的Covid-19病例在美国许多地区从高位下降，尽管在一些州正在增加。</blockquote></p><p> Federal health officials have pushed for boosters to sustain the immune protection in people who have been previously vaccinated, especially against Delta.</p><p><blockquote>联邦卫生官员一直在推动加强剂，以维持以前接种过疫苗的人的免疫保护，特别是针对Delta的疫苗。</blockquote></p><p> Up to 60 million people will become eligible for Pfizer’s booster shot in the coming weeks, the Biden administration has said.</p><p><blockquote>拜登政府表示，未来几周将有多达6000万人有资格接受辉瑞的加强注射。</blockquote></p><p> Adding Moderna’s additional shot would significantly expand the U.S. booster campaign. More than 69 million people in the U.S. are fully vaccinated with Moderna’s shot, according to the CDC.</p><p><blockquote>增加Moderna的额外注射将显着扩大美国的加强运动。据CDC称，美国有超过6900万人完全接种了Moderna疫苗。</blockquote></p><p> Moderna has asked the FDA to authorize a booster that is half the dosage of the first two vaccine doses, and is taken at least six months after the second dose.</p><p><blockquote>Moderna已要求FDA批准前两剂疫苗剂量一半的加强剂，并在第二剂疫苗接种后至少六个月服用。</blockquote></p><p> The booster shot increased immune responses in about 170 people in a Moderna study. The booster’s effect on immune responses met one goal in the study but fell slightly short on another goal, FDA staff said.</p><p><blockquote>在Moderna的一项研究中，加强注射增强了约170人的免疫反应。FDA工作人员表示，加强剂对免疫反应的影响达到了研究中的一个目标，但略低于另一个目标。</blockquote></p><p> Some members of the advisory panel expressed concern about the small size of the study, saying it limited their ability to assess the safety of the booster shots. The FDA said the safety profile of the booster was largely consistent with the first two doses.</p><p><blockquote>顾问小组的一些成员对这项研究的规模较小表示担忧，称这限制了他们评估加强注射安全性的能力。FDA表示，加强剂的安全性与前两剂基本一致。</blockquote></p><p> The panel also began to debate whether to make booster doses more widely available beyond the categories currently authorized, which include seniors and adults at high risk because of medical conditions or where they work.</p><p><blockquote>该小组还开始讨论是否在目前授权的类别之外更广泛地提供加强剂量，其中包括因医疗条件或工作地点而处于高风险的老年人和成年人。</blockquote></p><p> Some members said they were skeptical about the need to give an extra dose to everyone who was vaccinated because the shots appear to be working well and offer lasting protection for younger people.</p><p><blockquote>一些成员表示，他们怀疑是否有必要给每个接种疫苗的人额外注射一剂疫苗，因为疫苗似乎效果良好，并为年轻人提供持久的保护。</blockquote></p><p></p><p> “I don’t necessarily see the need for a sort of let it rip campaign for boosters for everyone who has ever been vaccinated,” said Michael Kurilla, director of clinical innovation at the National Center for Advancing Translational Sciences at the National Institutes of Health.</p><p><blockquote>美国国立卫生研究院国家转化科学促进中心临床创新主任迈克尔·库里拉(Michael Kurilla)表示：“我不一定认为有必要为每个接种过疫苗的人开展一场让它撕裂的活动。”</blockquote></p><p> Peter Marks, director of the FDA’s center for biologics evaluation and research, said the U.S. sees booster doses as a potentially important part of its strategy to mitigate cases heading into the winter.</p><p><blockquote>FDA生物制品评估和研究中心主任彼得·马克斯表示，美国认为加强剂量是其缓解冬季病例战略的潜在重要组成部分。</blockquote></p><p> “The problem here is we don’t know what we don’t know,” he said. “There are models that predict that we could potentially have another wave of Covid-19 as people go inside this winter.”</p><p><blockquote>“这里的问题是我们不知道我们不知道什么，”他说。“有模型预测，随着人们今年冬天进入室内，我们可能会出现另一波Covid-19。”</blockquote></p><p> The advisory panel will meet again on Friday to considerJohnson & Johnson’s application for a second dose and to review data on mixing and matching vaccines and boosters.</p><p><blockquote>顾问小组将于周五再次开会，考虑强生公司的第二剂申请，并审查混合和匹配疫苗和加强剂的数据。</blockquote></p><p> Covid-19 vaccines from Moderna and J&J are authorized for use in people 18 years and older, while the Pfizer-BioNTech vaccine is cleared for people 12 years and over.</p><p><blockquote>Moderna和J&J的新冠肺炎疫苗被授权用于18岁及以上的人群，而辉瑞-BioNTech疫苗被批准用于12岁及以上的人群。</blockquote></p><p> Outside the U.S., Israel, the U.K. and the European Medicines Agency have cleared use of boosters, and many countries have been rolling out the shots. The World Health Organization, however, has encouraged rich nations to delay booster campaigns and send doses to countries with limited supplies.</p><p><blockquote>在美国以外，以色列、英国和欧洲药品管理局已批准使用加强针，许多国家也已推出疫苗。然而，世界卫生组织鼓励富裕国家推迟加强疫苗接种活动，并向供应有限的国家发送疫苗。</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1102010434","content_text":"Moderna shares jumped 3% in premarket trading as Moderna booster shot backed by FDA advisory panel.\n\nVaccine experts advising the Food and Drug Administration voted 19 to 0 Thursday to recommend authorization of an extra dose of Moderna Inc.’s Covid-19 shot, a key step in making booster doses available to millions more people.\nA vaccine-advisory panel voted in favor of giving a Moderna booster shot at least six months after the second dose, to adults 65 years and older, as well as adults under 65 who are at high risk of severe Covid-19 or serious complications because of their jobs, living conditions or underlying medical conditions.\nThe panel voted in favor of a booster shot that is half the dosage of the first two doses. The FDA is expected to decide on whether to authorize the booster dose within days.\nModerna said the booster doses can be drawn from the same vials that contain the original two-dose vaccine series, meaning the boosters will be available soon after authorization.\nMembers of the FDA’s vaccine-advisory panel supported Moderna’s booster dose even though the evidence for it was from a small study and had mixed results.\n“It’s more a gut feeling rather than based on really truly serious data,” said Patrick Moore, a member of the committee and a professor of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. “The data itself is not strong, but it is certainly going in the direction that is supportive of this vote.”\nThe meeting is a regular part of the federal government’s evaluation of the vaccines and the latest move toward authorizing Covid-19 boosters. The FDA often asks its expert advisers to share their views before the agency decides whether to clear a medicine, and the agency usually follows the advisers’ recommendations.\nAfter clearing Covid-19 vaccines for adults starting late last year, the FDA has been in recent months evaluating applications to expand use of the shots to younger ages and to add an extra dose to bolster vaccinated people’s immune defenses, especially against the Delta variant.\nThe FDA has authorized the vaccine from Pfizer Inc.and partner BioNTech SE for adolescents. The agency also has already greenlighted booster doses of the Pfizer-BioNTech vaccine for seniors and adults at high risk of Covid-19 who received the shots already and are at least six months past their first vaccination.\nIt also has authorized boosters of the Pfizer-BioNTech and Moderna vaccines forcertain people with weakened immune systems.\nA Centers for Disease Control and Prevention advisory panel is scheduled to meet Oct. 20 to weigh endorsing an additional Moderna dose, before it becomes available to the general public. The CDC doesn’t have to accept the panel’s recommendation but usually does.\nThe meeting of the FDA panel, called the Vaccines and Related Biological Products Advisory Committee, comes as Covid-19 cases caused by the contagious Delta variant drop from highs in many parts of the country, though they are increasing in some states.\nFederal health officials have pushed for boosters to sustain the immune protection in people who have been previously vaccinated, especially against Delta.\nUp to 60 million people will become eligible for Pfizer’s booster shot in the coming weeks, the Biden administration has said.\nAdding Moderna’s additional shot would significantly expand the U.S. booster campaign. More than 69 million people in the U.S. are fully vaccinated with Moderna’s shot, according to the CDC.\nModerna has asked the FDA to authorize a booster that is half the dosage of the first two vaccine doses, and is taken at least six months after the second dose.\nThe booster shot increased immune responses in about 170 people in a Moderna study. The booster’s effect on immune responses met one goal in the study but fell slightly short on another goal, FDA staff said.\nSome members of the advisory panel expressed concern about the small size of the study, saying it limited their ability to assess the safety of the booster shots. The FDA said the safety profile of the booster was largely consistent with the first two doses.\nThe panel also began to debate whether to make booster doses more widely available beyond the categories currently authorized, which include seniors and adults at high risk because of medical conditions or where they work.\nSome members said they were skeptical about the need to give an extra dose to everyone who was vaccinated because the shots appear to be working well and offer lasting protection for younger people.\n“I don’t necessarily see the need for a sort of let it rip campaign for boosters for everyone who has ever been vaccinated,” said Michael Kurilla, director of clinical innovation at the National Center for Advancing Translational Sciences at the National Institutes of Health.\nPeter Marks, director of the FDA’s center for biologics evaluation and research, said the U.S. sees booster doses as a potentially important part of its strategy to mitigate cases heading into the winter.\n“The problem here is we don’t know what we don’t know,” he said. “There are models that predict that we could potentially have another wave of Covid-19 as people go inside this winter.”\nThe advisory panel will meet again on Friday to considerJohnson & Johnson’s application for a second dose and to review data on mixing and matching vaccines and boosters.\nCovid-19 vaccines from Moderna and J&J are authorized for use in people 18 years and older, while the Pfizer-BioNTech vaccine is cleared for people 12 years and over.\nOutside the U.S., Israel, the U.K. and the European Medicines Agency have cleared use of boosters, and many countries have been rolling out the shots. The World Health Organization, however, has encouraged rich nations to delay booster campaigns and send doses to countries with limited supplies.","news_type":1,"symbols_score_info":{"MRNA":0.9}},"isVote":1,"tweetType":1,"viewCount":929,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":["JE"],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":41,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/824148087"}
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