HeroSmurf
2021-10-15
My heart also pumped 3% faster too :)
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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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":824161686,"tweetId":"824161686","gmtCreate":1634291299410,"gmtModify":1634291299508,"author":{"id":3585642689958579,"idStr":"3585642689958579","authorId":3585642689958579,"authorIdStr":"3585642689958579","name":"HeroSmurf","avatar":"https://static.tigerbbs.com/6015b234d96461c6ef8db8d919ac3473","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":12,"crmLevelSwitch":0,"individualDisplayBadges":[],"wearingBadges":[],"fanSize":23,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"title":"","extraTitle":"","html":"<html><head></head><body><p>My heart also pumped 3% faster too :)</p></body></html>","htmlText":"<html><head></head><body><p>My heart also pumped 3% faster too :)</p></body></html>","text":"My heart also pumped 3% faster too :)","highlighted":1,"essential":1,"paper":1,"likeSize":9,"commentSize":1,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/824161686","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>在 FDA 顾问小组的支持下，Moderna 加强注射，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>为美国食品和药物管理局提供建议的疫苗专家周四以 19 票对 0 票建议授权额外注射一剂 Moderna 公司的 Covid-19 疫苗，这是让数百万人获得加强剂量的关键一步。</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给65岁及以上的成年人注射Moderna加强针，以及65岁以下的成年人，这些成年人由于其工作、生活条件或潜在的医疗条件而面临严重新冠肺炎或严重并发症的高风险。</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，这是前两剂剂量的一半。FDA预计将在几天内决定是否授权加强剂量。</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授权后很快提供。</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>美国食品和药物管理局的疫苗顾问小组成员支持 Moderna 的加强剂量，尽管其证据来自一项小型研究，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>“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（Patrick Moore）说：”这更多的是一种直觉，而不是基于真正严肃的数据。“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的”。</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对疫苗进行评估的常规组成部分，也是授权 Covid-19 加强剂的最新举措。美国食品和药物管理局在决定是否批准某种药品之前，经常会要求其专家顾问分享他们的观点，而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年人接种 Covid-19 疫苗后，美国食品和药物管理局最近几个月一直在评估申请，以将疫苗的使用范围扩大到更年轻的年龄段，并增加一剂额外的剂量，以增强接种者的免疫防御能力，尤其是抵御德尔塔变异毒株病毒的免疫防御能力。</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 已批准辉瑞公司和合作伙伴 BioNTech SE 的疫苗用于青少年。该机构还已经批准了辉瑞-BioNTech疫苗的加强剂量，用于老年人和新冠肺炎高风险成年人，这些老年人和成年人已经接种了疫苗，并且距离第一次接种疫苗至少过去了六个月。</blockquote></p><p> It also has authorized boosters of the Pfizer-BioNTech and Moderna vaccines forcertain people with weakened immune systems.</p><p><blockquote>它还授权辉瑞-BioNTech和Moderna疫苗的加强剂用于免疫系统较弱的人。</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的一个顾问小组定于10月20日召开会议，考虑在向公众提供额外的Moderna剂量之前批准该剂量。疾病预防控制中心不必接受专家小组的建议，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小组被称为疫苗和相关生物制品咨询委员会，会议召开之际，由传染性德尔塔变异毒株引起的新冠肺炎病例在该国许多地区从高点下降，尽管在一些州它们正在增加。</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，特别是针对德尔塔的人。</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，在未来几周内，将有多达 6000 万人有资格接种辉瑞公司的加强针。</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 的额外注射将大大扩大美国的加强疫苗接种活动。据美国疾病预防控制中心称，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 授权一种加强剂，该加强剂的剂量为前两剂疫苗剂量的一半，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，加强注射增加了大约170人的免疫反应。美国食品和药物管理局工作人员说，增强剂对免疫反应的影响达到了研究中的一个目标，但在另一个目标上略有不足。</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研究规模较小表示担忧，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>该小组还开始辩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，他们对是否需要给每个接种疫苗的人注射额外剂量持怀疑态度，因为疫苗似乎效果很好，为年轻人提供了持久的保护。</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）说：”我认为没有必要为所有接种过疫苗的人发起某种让它撕裂的运动。</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>美国食品和药物管理局生物制剂评估与研究中心主任彼得-马克斯（Peter Marks）说，美国将加强剂量视为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>“他说：”这里的问题是我们不知道我们不知道什么。“有模型预测，随着今年冬天人们进入室内，我们可能会迎来另一波 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>咨询小组将于周五再次召开会议，审议强生公司第二剂疫苗的申请，并审查疫苗和加强剂混合搭配的数据。</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经批准使用加强剂，许多国家已经开始推广疫苗。然而，世界卫生组织鼓励富裕国家推迟加强活动，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>在 FDA 顾问小组的支持下，Moderna 加强注射，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>为美国食品和药物管理局提供建议的疫苗专家周四以 19 票对 0 票建议授权额外注射一剂 Moderna 公司的 Covid-19 疫苗，这是让数百万人获得加强剂量的关键一步。</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给65岁及以上的成年人注射Moderna加强针，以及65岁以下的成年人，这些成年人由于其工作、生活条件或潜在的医疗条件而面临严重新冠肺炎或严重并发症的高风险。</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，这是前两剂剂量的一半。FDA预计将在几天内决定是否授权加强剂量。</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授权后很快提供。</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>美国食品和药物管理局的疫苗顾问小组成员支持 Moderna 的加强剂量，尽管其证据来自一项小型研究，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>“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（Patrick Moore）说：”这更多的是一种直觉，而不是基于真正严肃的数据。“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的”。</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对疫苗进行评估的常规组成部分，也是授权 Covid-19 加强剂的最新举措。美国食品和药物管理局在决定是否批准某种药品之前，经常会要求其专家顾问分享他们的观点，而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年人接种 Covid-19 疫苗后，美国食品和药物管理局最近几个月一直在评估申请，以将疫苗的使用范围扩大到更年轻的年龄段，并增加一剂额外的剂量，以增强接种者的免疫防御能力，尤其是抵御德尔塔变异毒株病毒的免疫防御能力。</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 已批准辉瑞公司和合作伙伴 BioNTech SE 的疫苗用于青少年。该机构还已经批准了辉瑞-BioNTech疫苗的加强剂量，用于老年人和新冠肺炎高风险成年人，这些老年人和成年人已经接种了疫苗，并且距离第一次接种疫苗至少过去了六个月。</blockquote></p><p> It also has authorized boosters of the Pfizer-BioNTech and Moderna vaccines forcertain people with weakened immune systems.</p><p><blockquote>它还授权辉瑞-BioNTech和Moderna疫苗的加强剂用于免疫系统较弱的人。</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的一个顾问小组定于10月20日召开会议，考虑在向公众提供额外的Moderna剂量之前批准该剂量。疾病预防控制中心不必接受专家小组的建议，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小组被称为疫苗和相关生物制品咨询委员会，会议召开之际，由传染性德尔塔变异毒株引起的新冠肺炎病例在该国许多地区从高点下降，尽管在一些州它们正在增加。</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，特别是针对德尔塔的人。</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，在未来几周内，将有多达 6000 万人有资格接种辉瑞公司的加强针。</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 的额外注射将大大扩大美国的加强疫苗接种活动。据美国疾病预防控制中心称，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 授权一种加强剂，该加强剂的剂量为前两剂疫苗剂量的一半，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，加强注射增加了大约170人的免疫反应。美国食品和药物管理局工作人员说，增强剂对免疫反应的影响达到了研究中的一个目标，但在另一个目标上略有不足。</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研究规模较小表示担忧，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>该小组还开始辩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，他们对是否需要给每个接种疫苗的人注射额外剂量持怀疑态度，因为疫苗似乎效果很好，为年轻人提供了持久的保护。</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）说：”我认为没有必要为所有接种过疫苗的人发起某种让它撕裂的运动。</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>美国食品和药物管理局生物制剂评估与研究中心主任彼得-马克斯（Peter Marks）说，美国将加强剂量视为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>“他说：”这里的问题是我们不知道我们不知道什么。“有模型预测，随着今年冬天人们进入室内，我们可能会迎来另一波 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>咨询小组将于周五再次召开会议，审议强生公司第二剂疫苗的申请，并审查疫苗和加强剂混合搭配的数据。</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经批准使用加强剂，许多国家已经开始推广疫苗。然而，世界卫生组织鼓励富裕国家推迟加强活动，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":803,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"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":30,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/824161686"}
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