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2021-11-19
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Pfizer and BioNTech SE stocks climbed about 2% in premarket trading<blockquote>辉瑞和 BioNTech SE 股票在盘前交易中上涨约 2%</blockquote>
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The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.</p><p><blockquote>辉瑞公司和BioNTech SE今天宣布，美国。美国食品药品监督管理局（FDA）已经扩大了辉瑞-BioNTech新冠肺炎疫苗加强剂量的紧急使用授权（EUA），将18岁及以上的个人包括在内。加强剂量应在初级系列完成后至少六个月施用，剂量强度与初级系列中的剂量相同。</blockquote></p><p> “As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”</p><p><blockquote>“辉瑞公司董事长兼首席执行官阿尔伯特-布尔拉（Albert Bourla）说：”随着我们抗击 COVID-19 的两年大关接近，我们又达到了一个重要的里程碑，扩大了 18 岁及以上人群接种 COVID-19 疫苗加强剂量的授权。“有了加强剂，更多的成年人现在将有机会帮助保持对这种疾病的高水平保护。我们感谢美国食品及药物管理局的严格审查，我们希望今天采取的行动将有助于加快我们摆脱这一大流行病的步伐。”</blockquote></p><p> “Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”</p><p><blockquote>“BioNTech公司首席执行官兼联合创始人、医学博士乌古尔-沙欣（Ugur Sahin）说：”今天美国食品和药物管理局的决定得到了临床数据的支持，这些数据显示，我们的疫苗加强剂量后会产生强劲的免疫反应，甚至超过了高效的两剂初级接种方案完成后的免疫反应。“这些数据表明，我们疫苗的加强剂量有可能对包括德尔塔在内的测试变种保持高水平的保护”。</blockquote></p><p> In October, the companies announced positive topline results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified.</p><p><blockquote>10 月，两家公司宣布了该试验的积极顶线结果显示，与未接受加强剂的人相比，对先前接受辉瑞-BioNTech 初级两剂系列的个体施用的加强剂量显示出 95% 的相对疫苗效力。到目前为止，这些是任何随机对照新冠肺炎疫苗加强试验中披露的第一个也是唯一一个疗效数据。不良事件概况与疫苗的其他临床安全性数据大致一致，未发现新的安全性问题。</blockquote></p><p> A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.</p><p><blockquote>辉瑞-BioNTech新冠肺炎疫苗的加强剂量此前已被FDA授权在65岁及以上的个体、18至64岁的严重新冠肺炎高风险个体和18至64岁的个体中紧急使用。经常在机构或职业中接触新型冠状病毒的18至64岁的个体，以及已完成不同授权新冠肺炎疫苗初次接种的合格个体。</blockquote></p><p> Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world.</p><p><blockquote>辉瑞和 BioNTech 根据与美国政府的现有供应协议继续供应疫苗，包括足够数量的加强剂，该协议将持续到 2022 年 4 月。这些公司预计今天的消息不会影响与世界各国政府和国际卫生组织现有的供应协议。</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>Pfizer and BioNTech SE stocks climbed about 2% in premarket trading<blockquote>辉瑞和 BioNTech SE 股票在盘前交易中上涨约 2%</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 and BioNTech SE stocks climbed about 2% in premarket trading<blockquote>辉瑞和 BioNTech SE 股票在盘前交易中上涨约 2%</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 21:32</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<p>Pfizer and BioNTech SE stocks climbed about 2% in premarket trading after they received expanded U.S. FDA emergency use authorization of booster to include individuals 18 and older.</p><p><blockquote>辉瑞和 BioNTech SE 的股价在盘前交易中上涨约 2%，此前它们获得了美国 FDA 扩大的加强剂紧急使用授权，将 18 岁及以上的个人包括在内。</blockquote></p><p> <img src=\"https://static.tigerbbs.com/a0ee0544027cc35ceeb2a44c7caf0848\" tg-width=\"850\" tg-height=\"619\" width=\"100%\" height=\"auto\"><img src=\"https://static.tigerbbs.com/026143e67c4e4f63fadd07b9b23e1301\" tg-width=\"850\" tg-height=\"617\" width=\"100%\" height=\"auto\"></p><p><blockquote></blockquote></p><p> Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.</p><p><blockquote>辉瑞公司和BioNTech SE今天宣布，美国。美国食品药品监督管理局（FDA）已经扩大了辉瑞-BioNTech新冠肺炎疫苗加强剂量的紧急使用授权（EUA），将18岁及以上的个人包括在内。加强剂量应在初级系列完成后至少六个月施用，剂量强度与初级系列中的剂量相同。</blockquote></p><p> “As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”</p><p><blockquote>“辉瑞公司董事长兼首席执行官阿尔伯特-布尔拉（Albert Bourla）说：”随着我们抗击 COVID-19 的两年大关接近，我们又达到了一个重要的里程碑，扩大了 18 岁及以上人群接种 COVID-19 疫苗加强剂量的授权。“有了加强剂，更多的成年人现在将有机会帮助保持对这种疾病的高水平保护。我们感谢美国食品及药物管理局的严格审查，我们希望今天采取的行动将有助于加快我们摆脱这一大流行病的步伐。”</blockquote></p><p> “Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”</p><p><blockquote>“BioNTech公司首席执行官兼联合创始人、医学博士乌古尔-沙欣（Ugur Sahin）说：”今天美国食品和药物管理局的决定得到了临床数据的支持，这些数据显示，我们的疫苗加强剂量后会产生强劲的免疫反应，甚至超过了高效的两剂初级接种方案完成后的免疫反应。“这些数据表明，我们疫苗的加强剂量有可能对包括德尔塔在内的测试变种保持高水平的保护”。</blockquote></p><p> In October, the companies announced positive topline results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified.</p><p><blockquote>10 月，两家公司宣布了该试验的积极顶线结果显示，与未接受加强剂的人相比，对先前接受辉瑞-BioNTech 初级两剂系列的个体施用的加强剂量显示出 95% 的相对疫苗效力。到目前为止，这些是任何随机对照新冠肺炎疫苗加强试验中披露的第一个也是唯一一个疗效数据。不良事件概况与疫苗的其他临床安全性数据大致一致，未发现新的安全性问题。</blockquote></p><p> A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.</p><p><blockquote>辉瑞-BioNTech新冠肺炎疫苗的加强剂量此前已被FDA授权在65岁及以上的个体、18至64岁的严重新冠肺炎高风险个体和18至64岁的个体中紧急使用。经常在机构或职业中接触新型冠状病毒的18至64岁的个体，以及已完成不同授权新冠肺炎疫苗初次接种的合格个体。</blockquote></p><p> Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world.</p><p><blockquote>辉瑞和 BioNTech 根据与美国政府的现有供应协议继续供应疫苗，包括足够数量的加强剂，该协议将持续到 2022 年 4 月。这些公司预计今天的消息不会影响与世界各国政府和国际卫生组织现有的供应协议。</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BNTX":"BioNTech SE","PFE":"辉瑞"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1144455380","content_text":"Pfizer and BioNTech SE stocks climbed about 2% in premarket trading after they received expanded U.S. FDA emergency use authorization of booster to include individuals 18 and older.\n\nPfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.\n“As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”\n“Today’s FDA decision is supported by clinical data showing robust immune responses following a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”\nIn October, the companies announced positive topline results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified.\nA booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.\nPfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. 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