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2021-11-02

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Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says<blockquote>Novavax COVID-19疫苗首次获得授权；首席执行官表示，预计几周内会有更多</blockquote>

(Reuters) -Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision

Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says<blockquote>Novavax COVID-19疫苗首次获得授权；首席执行官表示，预计几周内会有更多</blockquote>

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REUTERS/Dado Ruvic<blockquote>资料照片：在这张2020年10月30日拍摄的插图中，一名妇女在显示的Novavax标志前拿着一个贴有“冠状病毒COVID-19疫苗”标签的小瓶子和一个医用注射器。路透社/达多·鲁维奇</blockquote> Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.<blockquote>Novavax股价上涨约13%，此前该公司还表示已向加拿大和欧洲药品管理局提交了紧急使用该疫苗的申请。</blockquote> For Indonesia, the shot will be manufactured by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.<blockquote>对于印度尼西亚，该疫苗将由世界上最大的疫苗制造商印度血清研究所（SII）生产，并以印度公司的品牌Covovax销售。Novavax表示，预计即将开始向印度尼西亚发货。</blockquote> The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.<blockquote>世界卫生组织(WHO)也在审查Novavax的监管文件，这家美国制药商预计审查将在未来几周内得到解决，首席执行官斯坦利·埃尔克(Stanley Erck)周一在接受路透社电话采访时表示。</blockquote> A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.<blockquote>世卫组织的批准将为Novavax开始向COVAX计划运送疫苗奠定基础，该计划向低收入国家提供疫苗。Novavax和SII共同承诺向世卫组织共同领导的COVAX提供超过11亿剂疫苗。</blockquote> “I think we’ll get some doses to COVAX this year,” Erck said. “But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter” of 2022.<blockquote>“我认为我们今年会向COVAX提供一些剂量，”埃尔克说。“但我认为（Novavax）将在2022年第一季度真正开始能够向COVAX运送大量货物”。</blockquote> Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.<blockquote>Erck表示，Novavax已经解决了所有制造挑战，预计监管机构不会对其生产流程产生任何进一步的担忧。</blockquote> He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”<blockquote>他表示，Novavax“正在与美国FDA进行对话……我们预计将在未来几周内提交完整的申请。”</blockquote> Novavax had delayed filing for U.S. approval, and Politico reported last month that the company faced production and quality problems.<blockquote>Novavax推迟了申请美国批准的时间，Politico上个月报道称，该公司面临生产和质量问题。</blockquote> SII is authorized to make the Novavax vaccine and the U.S. company said it will apply for regulatory authorization for other facilities, such as its plant in the Czech republic, in the coming weeks.<blockquote>SII被授权生产Novavax疫苗，这家美国公司表示，将在未来几周内为其他设施申请监管授权，例如其在捷克共和国的工厂。</blockquote> Indonesia is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.<blockquote>据政府称，印度尼西亚今年预计将收到2000万剂基于蛋白质的疫苗。</blockquote> Penny Lukito, chief of the National Agency for Drug and Food Control of Indonesia, did not immediately respond to a Reuters request for comment.<blockquote>印度尼西亚国家药品和食品管制局局长彭妮·卢基托没有立即回应路透社的置评请求。</blockquote> Novavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.<blockquote>Novavax迄今已在多个国家申请EUA，包括英国、澳大利亚、印度和菲律宾。</blockquote> “It will be weeks, not months, for them to review” Novavax’s regulatory submissions and potentially clear the shot for use, Erck said.<blockquote>埃尔克表示，“他们需要几周而不是几个月的时间来审查”Novavax的监管文件，并可能批准使用该疫苗。</blockquote> The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.<blockquote>该公司与日本合作伙伴武田制药公司周五表示，正准备寻求监管部门批准明年初在日本推出。</blockquote> The Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.<blockquote>在美国的一项大型后期试验中，Novavax疫苗的有效性超过90%，包括针对各种令人担忧的冠状病毒变种。</blockquote>","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\">\nNovavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says<blockquote>Novavax COVID-19疫苗首次获得授权；首席执行官表示，预计几周内会有更多</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nReuters2021-11-02 07:54\n\n</h4>\n</header>\n<article>\n(Reuters) -Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.<blockquote>（路透社）-Novavax Inc.首席执行官告诉路透社，预计印度、菲律宾和其他地方的监管机构将在“几周”内对其COVID-19疫苗做出决定，此前该疫苗周一获得了印度尼西亚的首次紧急使用授权（EUA）。</blockquote> FILE PHOTO: A woman holds a small bottle labeled with a \"Coronavirus COVID-19 Vaccine\" sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic<blockquote>资料照片：在这张2020年10月30日拍摄的插图中，一名妇女在显示的Novavax标志前拿着一个贴有“冠状病毒COVID-19疫苗”标签的小瓶子和一个医用注射器。路透社/达多·鲁维奇</blockquote> Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.<blockquote>Novavax股价上涨约13%，此前该公司还表示已向加拿大和欧洲药品管理局提交了紧急使用该疫苗的申请。</blockquote> For Indonesia, the shot will be manufactured by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.<blockquote>对于印度尼西亚，该疫苗将由世界上最大的疫苗制造商印度血清研究所（SII）生产，并以印度公司的品牌Covovax销售。Novavax表示，预计即将开始向印度尼西亚发货。</blockquote> The World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.<blockquote>世界卫生组织(WHO)也在审查Novavax的监管文件，这家美国制药商预计审查将在未来几周内得到解决，首席执行官斯坦利·埃尔克(Stanley Erck)周一在接受路透社电话采访时表示。</blockquote> A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.<blockquote>世卫组织的批准将为Novavax开始向COVAX计划运送疫苗奠定基础，该计划向低收入国家提供疫苗。Novavax和SII共同承诺向世卫组织共同领导的COVAX提供超过11亿剂疫苗。</blockquote> “I think we’ll get some doses to COVAX this year,” Erck said. “But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter” of 2022.<blockquote>“我认为我们今年会向COVAX提供一些剂量，”埃尔克说。“但我认为（Novavax）将在2022年第一季度真正开始能够向COVAX运送大量货物”。</blockquote> Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.<blockquote>Erck表示，Novavax已经解决了所有制造挑战，预计监管机构不会对其生产流程产生任何进一步的担忧。</blockquote> He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”<blockquote>他表示，Novavax“正在与美国FDA进行对话……我们预计将在未来几周内提交完整的申请。”</blockquote> Novavax had delayed filing for U.S. approval, and Politico reported last month that the company faced production and quality problems.<blockquote>Novavax推迟了申请美国批准的时间，Politico上个月报道称，该公司面临生产和质量问题。</blockquote> SII is authorized to make the Novavax vaccine and the U.S. company said it will apply for regulatory authorization for other facilities, such as its plant in the Czech republic, in the coming weeks.<blockquote>SII被授权生产Novavax疫苗，这家美国公司表示，将在未来几周内为其他设施申请监管授权，例如其在捷克共和国的工厂。</blockquote> Indonesia is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.<blockquote>据政府称，印度尼西亚今年预计将收到2000万剂基于蛋白质的疫苗。</blockquote> Penny Lukito, chief of the National Agency for Drug and Food Control of Indonesia, did not immediately respond to a Reuters request for comment.<blockquote>印度尼西亚国家药品和食品管制局局长彭妮·卢基托没有立即回应路透社的置评请求。</blockquote> Novavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.<blockquote>Novavax迄今已在多个国家申请EUA，包括英国、澳大利亚、印度和菲律宾。</blockquote> “It will be weeks, not months, for them to review” Novavax’s regulatory submissions and potentially clear the shot for use, Erck said.<blockquote>埃尔克表示，“他们需要几周而不是几个月的时间来审查”Novavax的监管文件，并可能批准使用该疫苗。</blockquote> The company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.<blockquote>该公司与日本合作伙伴武田制药公司周五表示，正准备寻求监管部门批准明年初在日本推出。</blockquote> The Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.<blockquote>在美国的一项大型后期试验中，Novavax疫苗的有效性超过90%，包括针对各种令人担忧的冠状病毒变种。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://www.reuters.com/article/health-coronavirus-novavax/update-3-novavax-covid-19-vaccine-gets-first-authorization-expects-more-within-weeks-ceo-says-idUSL4N2RS2MV\">Reuters</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":{"NVAX":"诺瓦瓦克斯医药"},"source_url":"https://www.reuters.com/article/health-coronavirus-novavax/update-3-novavax-covid-19-vaccine-gets-first-authorization-expects-more-within-weeks-ceo-says-idUSL4N2RS2MV","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1118798908","content_text":"(Reuters) -Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.\nFILE PHOTO: A woman holds a small bottle labeled with a \"Coronavirus COVID-19 Vaccine\" sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic\nNovavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.\nFor Indonesia, the shot will be manufactured by the world’s largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company’s brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.\nThe World Health Organization (WHO) is also reviewing Novavax’s regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.\nA green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.\n“I think we’ll get some doses to COVAX this year,” Erck said. “But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter” of 2022.\nErck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.\nHe said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”\nNovavax had delayed filing for U.S. approval, and Politico reported last month that the company faced production and quality problems.\nSII is authorized to make the Novavax vaccine and the U.S. company said it will apply for regulatory authorization for other facilities, such as its plant in the Czech republic, in the coming weeks.\nIndonesia is slated to receive 20 million doses of the protein-based vaccine this year, according to the government.\nPenny Lukito, chief of the National Agency for Drug and Food Control of Indonesia, did not immediately respond to a Reuters request for comment.\nNovavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.\n“It will be weeks, not months, for them to review” Novavax’s regulatory submissions and potentially clear the shot for use, Erck said.\nThe company, along with Japanese partner Takeda Pharmaceutical Co, said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.\nThe Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.","news_type":1,"symbols_score_info":{"NVAX":0.9}},"isVote":1,"tweetType":1,"viewCount":1723,"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":10,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}

Novavax COVID-19 vaccine gets first authorization; expects more within weeks, CEO says<blockquote>Novavax COVID-19疫苗首次获得授权；首席执行官表示，预计几周内会有更多</blockquote>

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