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2021-11-21
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Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older<blockquote>Moderna宣布FDA授权美国18岁及以上成年人接种新冠疫苗加强剂量</blockquote>
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This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.</p><p><blockquote>Moderna公司今天宣布，美国。美国食品药品监督管理局(FDA)已将50µg剂量水平的Moderna COVID-19疫苗加强剂量的紧急使用授权扩大到所有18岁及以上的成年人。这种加强剂可用于所有18岁及以上已完成任何其他授权或批准的新冠肺炎疫苗初次接种的个人。</blockquote></p><p> “This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” saidStéphane Bancel, Chief Executive Officer ofModerna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”</p><p><blockquote>Moderna首席执行官Stéphane Bancel表示：“这项紧急使用授权是在我们进入冬季并面临全国范围内不断增加的COVID-19病例数和住院人数的关键时刻发布的。”“我们感谢FDA的审查，并对强有力的临床证据充满信心，即50µg加强剂量的mRNA-1273可诱导针对COVID-19的强烈免疫反应。”</blockquote></p><p> The booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. OnOctober 20th, the FDAauthorizedfor emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 µg mRNA 1273 third dose in immunocompromised individuals.</p><p><blockquote>加强剂量将在完成任何初级系列新冠肺炎疫苗接种后至少六个月进行。10月20日，FDA授权65岁及以上人群以及18至64岁严重COVID-19高风险成年人紧急使用50µg剂量水平的Moderna COVID-19疫苗加强剂量；以及经常在机构或职业上接触新型冠状病毒的18至64岁人群。在许多国际市场上，Moderna新冠肺炎加强疫苗被授权用于18岁及以上的成年人，无论职业风险因素如何。此前，100µg mRNA 1273第三剂在免疫功能低下个体中获得批准。</blockquote></p><p> The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.</p><p><blockquote>FDA根据该公司分享的全部科学证据制定了该EUA，包括mRNA-1273 2期临床研究的数据分析，该研究经过修订，以提供50µg剂量水平的mRNA-1273加强剂量。第二次给药后6-8个月感兴趣的参与者(n=344)。中和抗体滴度在加强之前减弱，特别是针对关注的变体，在大约6个月时。值得注意的是，50µg剂量水平的mRNA-1273加强剂量将中和滴度提高到显著高于3期基准。加强剂量后的安全性概况与先前针对mRNA-1273剂量2观察到的相似。</blockquote></p><p> As a next step, theU.S. Centers for Disease Controland Prevention’s (CDC) Advisory Committee on Immunization Practices(ACIP) will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.</p><p><blockquote>下一步，美国。美国疾病控制和预防中心（CDC）免疫实践咨询委员会（ACIP）将开会讨论向美国人推出新冠肺炎加强剂的潜在建议。</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 Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older<blockquote>Moderna宣布FDA授权美国18岁及以上成年人接种新冠疫苗加强剂量</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 Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older<blockquote>Moderna宣布FDA授权美国18岁及以上成年人接种新冠疫苗加强剂量</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\">2021-11-19 21:10</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Moderna stock surged 4% in premarket trading after announcing FDA authorization of booster dose of COVID-19 Vaccine in the U.S. for adults 18 years and older.</p><p><blockquote>在宣布FDA授权美国18岁及以上成年人接种加强剂量的COVID-19疫苗后，Moderna股价在盘前交易中飙升4%。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/b8db683899273d344e819a53f4b3366b\" tg-width=\"850\" tg-height=\"620\" referrerpolicy=\"no-referrer\"></p><p><blockquote></blockquote></p><p> Moderna, Inc. today announced that theU.S. Food and Drug Administration(FDA) has extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.</p><p><blockquote>Moderna公司今天宣布，美国。美国食品药品监督管理局(FDA)已将50µg剂量水平的Moderna COVID-19疫苗加强剂量的紧急使用授权扩大到所有18岁及以上的成年人。这种加强剂可用于所有18岁及以上已完成任何其他授权或批准的新冠肺炎疫苗初次接种的个人。</blockquote></p><p> “This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” saidStéphane Bancel, Chief Executive Officer ofModerna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”</p><p><blockquote>Moderna首席执行官Stéphane Bancel表示：“这项紧急使用授权是在我们进入冬季并面临全国范围内不断增加的COVID-19病例数和住院人数的关键时刻发布的。”“我们感谢FDA的审查，并对强有力的临床证据充满信心，即50µg加强剂量的mRNA-1273可诱导针对COVID-19的强烈免疫反应。”</blockquote></p><p> The booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. OnOctober 20th, the FDAauthorizedfor emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 µg mRNA 1273 third dose in immunocompromised individuals.</p><p><blockquote>加强剂量将在完成任何初级系列新冠肺炎疫苗接种后至少六个月进行。10月20日，FDA授权65岁及以上人群以及18至64岁严重COVID-19高风险成年人紧急使用50µg剂量水平的Moderna COVID-19疫苗加强剂量；以及经常在机构或职业上接触新型冠状病毒的18至64岁人群。在许多国际市场上，Moderna新冠肺炎加强疫苗被授权用于18岁及以上的成年人，无论职业风险因素如何。此前，100µg mRNA 1273第三剂在免疫功能低下个体中获得批准。</blockquote></p><p> The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.</p><p><blockquote>FDA根据该公司分享的全部科学证据制定了该EUA，包括mRNA-1273 2期临床研究的数据分析，该研究经过修订，以提供50µg剂量水平的mRNA-1273加强剂量。第二次给药后6-8个月感兴趣的参与者(n=344)。中和抗体滴度在加强之前减弱，特别是针对关注的变体，在大约6个月时。值得注意的是，50µg剂量水平的mRNA-1273加强剂量将中和滴度提高到显著高于3期基准。加强剂量后的安全性概况与先前针对mRNA-1273剂量2观察到的相似。</blockquote></p><p> As a next step, theU.S. Centers for Disease Controland Prevention’s (CDC) Advisory Committee on Immunization Practices(ACIP) will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.</p><p><blockquote>下一步，美国。美国疾病控制和预防中心（CDC）免疫实践咨询委员会（ACIP）将开会讨论向美国人推出新冠肺炎加强剂的潜在建议。</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":"1138047553","content_text":"Moderna stock surged 4% in premarket trading after announcing FDA authorization of booster dose of COVID-19 Vaccine in the U.S. for adults 18 years and older.\n\nModerna, Inc. today announced that theU.S. Food and Drug Administration(FDA) has extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.\n“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” saidStéphane Bancel, Chief Executive Officer ofModerna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”\nThe booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. OnOctober 20th, the FDAauthorizedfor emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 µg mRNA 1273 third dose in immunocompromised individuals.\nThe FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.\nAs a next step, theU.S. Centers for Disease Controland Prevention’s (CDC) Advisory Committee on Immunization Practices(ACIP) will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.","news_type":1,"symbols_score_info":{"MRNA":0.9}},"isVote":1,"tweetType":1,"viewCount":720,"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":20,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/872362003"}
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