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2021-12-20
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EU regulator backs Novavax shot as region's fifth COVID-19 vaccine<blockquote>欧盟监管机构支持Novavax作为该地区第五种COVID-19疫苗</blockquote>
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The European Medicines Agency started a rolling review of the data in February.</p><p><blockquote>欧盟的监管程序也比预期的要长。欧洲药品管理局于2月份开始对数据进行滚动审查。</blockquote></p><p> Novavax and the EU reached a preliminary deal in December 2020 for the supply of the vaccine, but due to regulatory and production issues the final contract for up to 200 million doses was only signed in August.</p><p><blockquote>Novavax和欧盟在2020年12月就该疫苗的供应达成了初步协议，但由于监管和生产问题，最多2亿剂的最终合同直到8月才签署。</blockquote></p><p> The company said on Monday it would start shipping vaccines to the EU's 27 member states in January.</p><p><blockquote>该公司周一表示，将于1月份开始向欧盟27个成员国运送疫苗。</blockquote></p><p> The shot received its first regulatory greenlight in Indonesia last month and is awaiting approval in Japan, where it would be manufactured and distributed by Takeda Pharmaceutical .</p><p><blockquote>该疫苗上个月在印度尼西亚首次获得监管批准，目前正在日本等待批准，由武田制药在日本生产和分销。</blockquote></p><p></p>","source":"lsy1612507957220","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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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\">\nEU regulator backs Novavax shot as region's fifth COVID-19 vaccine<blockquote>欧盟监管机构支持Novavax作为该地区第五种COVID-19疫苗</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Reuters</strong><span class=\"h-time small\">2021-12-20 21:31</span>\n</p>\n</h4>\n</header>\n<article>\n<p>Dec 20 (Reuters) - The European Union's drug regulator on Monday approved use of the COVID-19 vaccine from U.S.-based Novavax in people 18 years and older, paving the way for a fifth coronavirus shot in the region as the Omicron coronavirus variant spreads.</p><p><blockquote>路透12月20日-欧盟药品监管机构周一批准在18岁及以上人群中使用美国Novavax的COVID-19疫苗，为随着奥密克戎冠状病毒变种在该地区注射第五剂冠状病毒铺平了道路传播。</blockquote></p><p> Data from two large studies showed the vaccine has an efficacy of around 90%, the European Medicines Agency (EMA) said, adding that there was currently limited data on its efficacy against some variants of concern, including Omicron.</p><p><blockquote>欧洲药品管理局(EMA)表示，两项大型研究的数据显示，该疫苗的有效性约为90%，并补充说，目前关于其对包括奥密克戎病毒在内的一些令人担忧的变种的有效性的数据有限。</blockquote></p><p> \"After a thorough evaluation, EMA's human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality,\" the regulator said.</p><p><blockquote>该监管机构表示：“经过彻底评估，EMA人类药物委员会(CHMP)一致得出结论，该疫苗的数据可靠，符合欧盟的功效、安全性和质量标准。”</blockquote></p><p> COVID-19 infections have broken records in parts of Europe in recent weeks, with governments and researchers scrambling to bolster defences against the fast-spreading Omicron coronavirus variant, prompting renewed curbs ahead of the holidays.</p><p><blockquote>最近几周，欧洲部分地区的COVID-19感染人数打破了记录，各国政府和研究人员争先恐后地加强对快速传播的奥密克戎冠状病毒变种的防御，促使在假期前重新采取限制措施。</blockquote></p><p> The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorisation in the United States, where Novavax has had to resolve manufacturing issues and expects to file for approval by the end of the year.</p><p><blockquote>Nuvaxovid品牌的两剂疫苗的批准远远早于美国可能获得授权，Novavax必须在美国解决生产问题，预计将在今年年底前申请批准。</blockquote></p><p> The regulatory process in the EU has taken longer than expected too. The European Medicines Agency started a rolling review of the data in February.</p><p><blockquote>欧盟的监管程序也比预期的要长。欧洲药品管理局于2月份开始对数据进行滚动审查。</blockquote></p><p> Novavax and the EU reached a preliminary deal in December 2020 for the supply of the vaccine, but due to regulatory and production issues the final contract for up to 200 million doses was only signed in August.</p><p><blockquote>Novavax和欧盟在2020年12月就该疫苗的供应达成了初步协议，但由于监管和生产问题，最多2亿剂的最终合同直到8月才签署。</blockquote></p><p> The company said on Monday it would start shipping vaccines to the EU's 27 member states in January.</p><p><blockquote>该公司周一表示，将于1月份开始向欧盟27个成员国运送疫苗。</blockquote></p><p> The shot received its first regulatory greenlight in Indonesia last month and is awaiting approval in Japan, where it would be manufactured and distributed by Takeda Pharmaceutical .</p><p><blockquote>该疫苗上个月在印度尼西亚首次获得监管批准，目前正在日本等待批准，由武田制药在日本生产和分销。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://finance.yahoo.com/news/1-eu-regulator-backs-novavax-131648310.html\">Reuters</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NVAX":"诺瓦瓦克斯医药"},"source_url":"https://finance.yahoo.com/news/1-eu-regulator-backs-novavax-131648310.html","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1116982212","content_text":"Dec 20 (Reuters) - The European Union's drug regulator on Monday approved use of the COVID-19 vaccine from U.S.-based Novavax in people 18 years and older, paving the way for a fifth coronavirus shot in the region as the Omicron coronavirus variant spreads.\nData from two large studies showed the vaccine has an efficacy of around 90%, the European Medicines Agency (EMA) said, adding that there was currently limited data on its efficacy against some variants of concern, including Omicron.\n\"After a thorough evaluation, EMA's human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality,\" the regulator said.\nCOVID-19 infections have broken records in parts of Europe in recent weeks, with governments and researchers scrambling to bolster defences against the fast-spreading Omicron coronavirus variant, prompting renewed curbs ahead of the holidays.\nThe endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorisation in the United States, where Novavax has had to resolve manufacturing issues and expects to file for approval by the end of the year.\nThe regulatory process in the EU has taken longer than expected too. The European Medicines Agency started a rolling review of the data in February.\nNovavax and the EU reached a preliminary deal in December 2020 for the supply of the vaccine, but due to regulatory and production issues the final contract for up to 200 million doses was only signed in August.\nThe company said on Monday it would start shipping vaccines to the EU's 27 member states in January.\nThe shot received its first regulatory greenlight in Indonesia last month and is awaiting approval in Japan, where it would be manufactured and distributed by Takeda Pharmaceutical .","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":3300,"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":7,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/693870376"}
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