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2021-08-17

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Pfizer, BioNTech Seek FDA Clearance for Covid-19 Booster<blockquote>辉瑞和BioNTech寻求FDA批准Covid-19加强剂</blockquote>

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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":839290462,"tweetId":"839290462","gmtCreate":1629159772056,"gmtModify":1631888928564,"author":{"id":3586332417338594,"idStr":"3586332417338594","authorId":3586332417338594,"authorIdStr":"3586332417338594","name":"YangXH","avatar":"https://static.tigerbbs.com/2da16ba61657b694381bbd12971282c6","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[],"fanSize":8,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"extraTitle":"","html":"<html><head></head><body>Nice</body></html>","htmlText":"<html><head></head><body>Nice</body></html>","text":"Nice","highlighted":1,"essential":1,"paper":1,"likeSize":4,"commentSize":0,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/839290462","repostId":1166738043,"repostType":4,"repost":{"id":"1166738043","kind":"news","pubTimestamp":1629158127,"share":"https://www.laohu8.com/m/news/1166738043?lang=zh_CN&edition=full","pubTime":"2021-08-17 07:55","market":"us","language":"en","title":"Pfizer, BioNTech Seek FDA Clearance for Covid-19 Booster<blockquote>辉瑞和BioNTech寻求FDA批准Covid-19加强剂</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1166738043","media":"The Wall Street Journal","summary":"Early-stage study shows third dose of vaccine offers a higher level of protection, companies say\nThe","content":"Early-stage study shows third dose of vaccine offers a higher level of protection, companies say<blockquote>公司表示，早期研究表明第三剂疫苗可提供更高水平的保护</blockquote> <img src=\"https://static.tigerbbs.com/14a5e62531f6fe58f57ee8f19db73a40\" tg-width=\"860\" tg-height=\"573\" width=\"100%\" height=\"auto\">The addition of a third dose appeared safe, Pfizer and BioNTech said. A Covid-19 vaccination at a Schwenksville, Pa., pharmacy.<blockquote>辉瑞和BioNTech表示，添加第三剂似乎是安全的。宾夕法尼亚州施文克斯维尔的新冠肺炎疫苗接种。，药房。</blockquote> Pfizer&nbsp;Inc.&nbsp;and partner&nbsp;BioNTech SE&nbsp;have submitted data to U.S. health regulators needed to cleara Covid-19 booster shot among the general public.<blockquote>辉瑞公司和合作伙伴BioNTech SE已向美国卫生监管机构提交了在公众中清除Covid-19加强注射所需的数据。</blockquote> The companies said Monday they sent to the U.S. Food and Drug Administration results from a small, early-stage study showing a third dose of their vaccine generated higher levels of neutralizing antibodies against the original virus and against the Beta and Delta variants than the standard two-dose regimen.<blockquote>这些公司周一表示，他们向美国发送了。美国食品和药物管理局的一项小型早期研究结果显示，与标准的两剂方案相比，第三剂疫苗产生了更高水平的针对原始病毒以及针对β和δ变异体的中和抗体。</blockquote> The addition of the third dose also appeared safe in the trial, the companies said.<blockquote>两家公司表示，在试验中添加第三剂似乎也是安全的。</blockquote> Given the immune response boost from a third dose, the companies said, a booster shot within six months to a year after the second shot might help maintain protection against&nbsp;symptomatic Covid-19.<blockquote>两家公司表示，鉴于第三剂疫苗的免疫反应增强，在第二剂疫苗接种后六个月至一年内进行加强注射可能有助于保持对有症状的Covid-19的保护。</blockquote> Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA.<blockquote>辉瑞和BioNTech也在进行一项更大规模的后期研究，评估第三剂疫苗是否能安全地提供更多保护。两家公司表示，他们预计这些结果将很快公布，然后将向FDA提交数据。</blockquote> The FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.<blockquote>FDA正在考虑一个更广泛的加强策略，该机构可能会在未来几周内发布。</blockquote> Two doses of the Pfizer-BioNTech shot, given three weeks apart, are authorized for people ages 12 years and older.<blockquote>两剂辉瑞-BioNTech疫苗被授权用于12岁及以上的人群，间隔三周注射。</blockquote> Some physicians and scientists in the U.S. say there isn’t a clear answer yet on whether boosters are needed for the general population, partly because of evidence that shows vaccines continue to be highly effective at preventing severe disease.<blockquote>美国的一些医生和科学家表示，对于普通人群是否需要加强剂，目前还没有明确的答案，部分原因是有证据表明疫苗在预防严重疾病方面仍然非常有效。</blockquote> Studies indicate the vaccine is still highly effective in people&nbsp;six months after their second dose. Yet there is some evidence its efficacy might diminish over longer periods, and the shot isn’t as effective againstt&nbsp;he Delta variant, prompting research into adding a third dose.<blockquote>研究表明，该疫苗在接种第二剂疫苗六个月后仍然非常有效。然而，有一些证据表明，随着时间的推移，它的功效可能会减弱，而且这种疫苗对德尔塔变异毒株病的疗效并不那么有效，这促使研究增加第三剂。</blockquote> Last week, the FDA authorized a third dose of an mRNA vaccine like the Pfizer-BioNTech shot&nbsp;for certain people with weakened immune systems, in a bid to bolster their immune defenses against Covid-19.<blockquote>上周，FDA批准为某些免疫系统较弱的人注射第三剂mRNA疫苗，例如辉瑞-BioNTech疫苗，以增强他们对Covid-19的免疫防御。</blockquote> In the early-stage study looking at a booster among generally healthy people, subjects got a third 30-microgram dose, Pfizer and BioNTech said. The subjects received the extra dose eight to nine months after receiving their second dose.<blockquote>辉瑞和BioNTech表示，在针对一般健康人群的早期研究中，受试者接受了第三剂30微克剂量。受试者在接受第二剂后8至9个月接受额外剂量。</blockquote> Then researchers measured in subjects their levels of neutralizing antibodies, which play a crucial role in protection against the virus, the companies said.<blockquote>两家公司表示，然后研究人员测量了受试者的中和抗体水平，中和抗体在预防病毒方面发挥着至关重要的作用。</blockquote> The levels rose against the initial strain of the virus, as well as the Beta and Delta variants, the companies said. After the booster dose, neutralizing antibodies against the variants were similar to the earlier strain, the companies said.<blockquote>两家公司表示，针对病毒的初始毒株以及Beta和Delta变种，水平有所上升。两家公司表示，加强剂量后，针对变种的中和抗体与早期菌株相似。</blockquote> Pfizer presented some of the scientific data during its second-quarter earnings presentation last month, but hasn’t detailed the results yet. After a third shot, antibody levels were up more than five times among people ages 18 to 55 and more than 11 times in people ages 65 to 85, compared with two doses, according to Pfizer’s data.<blockquote>辉瑞在上个月的第二季度财报中公布了一些科学数据，但尚未详细说明结果。辉瑞的数据显示，第三次注射后，与注射两剂相比，18至55岁人群的抗体水平上升了5倍以上，65至85岁人群的抗体水平上升了11倍以上。</blockquote>","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>Pfizer, BioNTech Seek FDA Clearance for Covid-19 Booster<blockquote>辉瑞和BioNTech寻求FDA批准Covid-19加强剂</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\">\nPfizer, BioNTech Seek FDA Clearance for Covid-19 Booster<blockquote>辉瑞和BioNTech寻求FDA批准Covid-19加强剂</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nThe Wall Street Journal2021-08-17 07:55\n\n</h4>\n</header>\n<article>\nEarly-stage study shows third dose of vaccine offers a higher level of protection, companies say<blockquote>公司表示，早期研究表明第三剂疫苗可提供更高水平的保护</blockquote> <img src=\"https://static.tigerbbs.com/14a5e62531f6fe58f57ee8f19db73a40\" tg-width=\"860\" tg-height=\"573\" width=\"100%\" height=\"auto\">The addition of a third dose appeared safe, Pfizer and BioNTech said. A Covid-19 vaccination at a Schwenksville, Pa., pharmacy.<blockquote>辉瑞和BioNTech表示，添加第三剂似乎是安全的。宾夕法尼亚州施文克斯维尔的新冠肺炎疫苗接种。，药房。</blockquote> Pfizer&nbsp;Inc.&nbsp;and partner&nbsp;BioNTech SE&nbsp;have submitted data to U.S. health regulators needed to cleara Covid-19 booster shot among the general public.<blockquote>辉瑞公司和合作伙伴BioNTech SE已向美国卫生监管机构提交了在公众中清除Covid-19加强注射所需的数据。</blockquote> The companies said Monday they sent to the U.S. Food and Drug Administration results from a small, early-stage study showing a third dose of their vaccine generated higher levels of neutralizing antibodies against the original virus and against the Beta and Delta variants than the standard two-dose regimen.<blockquote>这些公司周一表示，他们向美国发送了。美国食品和药物管理局的一项小型早期研究结果显示，与标准的两剂方案相比，第三剂疫苗产生了更高水平的针对原始病毒以及针对β和δ变异体的中和抗体。</blockquote> The addition of the third dose also appeared safe in the trial, the companies said.<blockquote>两家公司表示，在试验中添加第三剂似乎也是安全的。</blockquote> Given the immune response boost from a third dose, the companies said, a booster shot within six months to a year after the second shot might help maintain protection against&nbsp;symptomatic Covid-19.<blockquote>两家公司表示，鉴于第三剂疫苗的免疫反应增强，在第二剂疫苗接种后六个月至一年内进行加强注射可能有助于保持对有症状的Covid-19的保护。</blockquote> Pfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA.<blockquote>辉瑞和BioNTech也在进行一项更大规模的后期研究，评估第三剂疫苗是否能安全地提供更多保护。两家公司表示，他们预计这些结果将很快公布，然后将向FDA提交数据。</blockquote> The FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.<blockquote>FDA正在考虑一个更广泛的加强策略，该机构可能会在未来几周内发布。</blockquote> Two doses of the Pfizer-BioNTech shot, given three weeks apart, are authorized for people ages 12 years and older.<blockquote>两剂辉瑞-BioNTech疫苗被授权用于12岁及以上的人群，间隔三周注射。</blockquote> Some physicians and scientists in the U.S. say there isn’t a clear answer yet on whether boosters are needed for the general population, partly because of evidence that shows vaccines continue to be highly effective at preventing severe disease.<blockquote>美国的一些医生和科学家表示，对于普通人群是否需要加强剂，目前还没有明确的答案，部分原因是有证据表明疫苗在预防严重疾病方面仍然非常有效。</blockquote> Studies indicate the vaccine is still highly effective in people&nbsp;six months after their second dose. Yet there is some evidence its efficacy might diminish over longer periods, and the shot isn’t as effective againstt&nbsp;he Delta variant, prompting research into adding a third dose.<blockquote>研究表明，该疫苗在接种第二剂疫苗六个月后仍然非常有效。然而，有一些证据表明，随着时间的推移，它的功效可能会减弱，而且这种疫苗对德尔塔变异毒株病的疗效并不那么有效，这促使研究增加第三剂。</blockquote> Last week, the FDA authorized a third dose of an mRNA vaccine like the Pfizer-BioNTech shot&nbsp;for certain people with weakened immune systems, in a bid to bolster their immune defenses against Covid-19.<blockquote>上周，FDA批准为某些免疫系统较弱的人注射第三剂mRNA疫苗，例如辉瑞-BioNTech疫苗，以增强他们对Covid-19的免疫防御。</blockquote> In the early-stage study looking at a booster among generally healthy people, subjects got a third 30-microgram dose, Pfizer and BioNTech said. The subjects received the extra dose eight to nine months after receiving their second dose.<blockquote>辉瑞和BioNTech表示，在针对一般健康人群的早期研究中，受试者接受了第三剂30微克剂量。受试者在接受第二剂后8至9个月接受额外剂量。</blockquote> Then researchers measured in subjects their levels of neutralizing antibodies, which play a crucial role in protection against the virus, the companies said.<blockquote>两家公司表示，然后研究人员测量了受试者的中和抗体水平，中和抗体在预防病毒方面发挥着至关重要的作用。</blockquote> The levels rose against the initial strain of the virus, as well as the Beta and Delta variants, the companies said. After the booster dose, neutralizing antibodies against the variants were similar to the earlier strain, the companies said.<blockquote>两家公司表示，针对病毒的初始毒株以及Beta和Delta变种，水平有所上升。两家公司表示，加强剂量后，针对变种的中和抗体与早期菌株相似。</blockquote> Pfizer presented some of the scientific data during its second-quarter earnings presentation last month, but hasn’t detailed the results yet. After a third shot, antibody levels were up more than five times among people ages 18 to 55 and more than 11 times in people ages 65 to 85, compared with two doses, according to Pfizer’s data.<blockquote>辉瑞在上个月的第二季度财报中公布了一些科学数据，但尚未详细说明结果。辉瑞的数据显示，第三次注射后，与注射两剂相比，18至55岁人群的抗体水平上升了5倍以上，65至85岁人群的抗体水平上升了11倍以上。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://www.wsj.com/articles/pfizer-biontech-seek-fda-clearance-for-covid-19-booster-11629136057?mod=hp_lead_pos6\">The Wall Street Journal</a>\n为提升您的阅读体验，我们对本页面进行了排版优化\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"PFE":"辉瑞","BNTX":"BioNTech SE"},"source_url":"https://www.wsj.com/articles/pfizer-biontech-seek-fda-clearance-for-covid-19-booster-11629136057?mod=hp_lead_pos6","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1166738043","content_text":"Early-stage study shows third dose of vaccine offers a higher level of protection, companies say\nThe addition of a third dose appeared safe, Pfizer and BioNTech said. A Covid-19 vaccination at a Schwenksville, Pa., pharmacy.\nPfizer Inc. and partner BioNTech SE have submitted data to U.S. health regulators needed to cleara Covid-19 booster shot among the general public.\nThe companies said Monday they sent to the U.S. Food and Drug Administration results from a small, early-stage study showing a third dose of their vaccine generated higher levels of neutralizing antibodies against the original virus and against the Beta and Delta variants than the standard two-dose regimen.\nThe addition of the third dose also appeared safe in the trial, the companies said.\nGiven the immune response boost from a third dose, the companies said, a booster shot within six months to a year after the second shot might help maintain protection against symptomatic Covid-19.\nPfizer and BioNTech are also conducting a larger late-stage study evaluating whether a third dose safely provides more protection. The companies said they expect those results shortly and will then submit the data to the FDA.\nThe FDA is considering a broader booster strategy, which the agency could issue in the next few weeks.\nTwo doses of the Pfizer-BioNTech shot, given three weeks apart, are authorized for people ages 12 years and older.\nSome physicians and scientists in the U.S. say there isn’t a clear answer yet on whether boosters are needed for the general population, partly because of evidence that shows vaccines continue to be highly effective at preventing severe disease.\nStudies indicate the vaccine is still highly effective in people six months after their second dose. Yet there is some evidence its efficacy might diminish over longer periods, and the shot isn’t as effective againstt he Delta variant, prompting research into adding a third dose.\nLast week, the FDA authorized a third dose of an mRNA vaccine like the Pfizer-BioNTech shot for certain people with weakened immune systems, in a bid to bolster their immune defenses against Covid-19.\nIn the early-stage study looking at a booster among generally healthy people, subjects got a third 30-microgram dose, Pfizer and BioNTech said. The subjects received the extra dose eight to nine months after receiving their second dose.\nThen researchers measured in subjects their levels of neutralizing antibodies, which play a crucial role in protection against the virus, the companies said.\nThe levels rose against the initial strain of the virus, as well as the Beta and Delta variants, the companies said. After the booster dose, neutralizing antibodies against the variants were similar to the earlier strain, the companies said.\nPfizer presented some of the scientific data during its second-quarter earnings presentation last month, but hasn’t detailed the results yet. After a third shot, antibody levels were up more than five times among people ages 18 to 55 and more than 11 times in people ages 65 to 85, compared with two doses, according to Pfizer’s data.","news_type":1,"symbols_score_info":{"BNTX":0.9,"PFE":0.9}},"isVote":1,"tweetType":1,"viewCount":335,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":4,"xxTargetLangEnum":"ORIG"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/839290462"}