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2021-11-19
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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 批准在美国为 18 岁及以上成年人接种加强剂量的 COVID-19 疫苗</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, Inc. 今天宣布，美国。美国食品药品监督管理局 (FDA) 已将 50 µg 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 首席执行官斯特凡-班塞尔（Stéphane Bancel）说：”这项紧急使用授权正值我们进入冬季的关键时刻，全国范围内 COVID-19 病例数和住院人数不断增加。“我们感谢美国食品和药物管理局的审查，并对强有力的临床证据充满信心，即 50 µg 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>加强剂量应在完成任何初级系列新冠肺炎疫苗接种后至少六个月施用。10 月 20 日，FDA 授权紧急使用 50 µg 剂量水平的 Moderna COVID-19 疫苗加强剂量，用于 65 岁及以上的人群以及 18 至 64 岁的成年人，他们处于严重 COVID-19 的高风险；以及经常在机构或职业中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。在此之前，100 µg mRNA 1273 第三剂已被批准用于免疫功能低下的个体。</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 基于该公司共享的所有科学证据，包括 mRNA-1273 2 期临床研究的数据分析，该研究经过修订，在第二次给药后 6-8 个月向感兴趣的参与者提供 50 µg 剂量水平的 mRNA-1273 加强剂量（n=344）。中和抗体滴度在加强之前已经减弱，特别是针对关注的变体，在大约6个月时。值得注意的是，50 µg 剂量水平的 mRNA-1273 加强剂量使中和滴度显著高于 3 期基准。加强剂量后的安全性特征与先前观察到的mRNA-1273剂量2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。美国疾病控制中心（CDC）免疫实践咨询委员会（ACIP）将召开会议，讨论向美国人推广 COVID-19 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 批准在美国为 18 岁及以上成年人接种加强剂量的 COVID-19 疫苗</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; 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}\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 批准在美国为 18 岁及以上成年人接种加强剂量的 COVID-19 疫苗</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>Moderna 宣布 FDA 批准在美国为 18 岁及以上成年人接种加强剂量 COVID-19 疫苗后，其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, Inc. 今天宣布，美国。美国食品药品监督管理局 (FDA) 已将 50 µg 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 首席执行官斯特凡-班塞尔（Stéphane Bancel）说：”这项紧急使用授权正值我们进入冬季的关键时刻，全国范围内 COVID-19 病例数和住院人数不断增加。“我们感谢美国食品和药物管理局的审查，并对强有力的临床证据充满信心，即 50 µg 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>加强剂量应在完成任何初级系列新冠肺炎疫苗接种后至少六个月施用。10 月 20 日，FDA 授权紧急使用 50 µg 剂量水平的 Moderna COVID-19 疫苗加强剂量，用于 65 岁及以上的人群以及 18 至 64 岁的成年人，他们处于严重 COVID-19 的高风险；以及经常在机构或职业中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。在此之前，100 µg mRNA 1273 第三剂已被批准用于免疫功能低下的个体。</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 基于该公司共享的所有科学证据，包括 mRNA-1273 2 期临床研究的数据分析，该研究经过修订，在第二次给药后 6-8 个月向感兴趣的参与者提供 50 µg 剂量水平的 mRNA-1273 加强剂量（n=344）。中和抗体滴度在加强之前已经减弱，特别是针对关注的变体，在大约6个月时。值得注意的是，50 µg 剂量水平的 mRNA-1273 加强剂量使中和滴度显著高于 3 期基准。加强剂量后的安全性特征与先前观察到的mRNA-1273剂量2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。美国疾病控制中心（CDC）免疫实践咨询委员会（ACIP）将召开会议，讨论向美国人推广 COVID-19 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":1161,"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":4,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/876508553"}
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