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UPDATE 1-EU reviewing data on Moderna's COVID-19 booster shot
UPDATE 1-EU reviewing data on Moderna's COVID-19 booster shot
(Adds background)
Sept 27 (Reuters) - The European Union's (EU) drug regulator said on Monday it was evaluating whether a booster dose of Moderna's MRNA.O COVID-19 vaccine could be given at least six months after the second shot of the two-dose course in people over 12 years of age.
The review by the European Medicines Agency (EMA) comes after its statement last week that it aims to decide in early October whether to endorse a booster for Pfizer-BioNTech PFE.N
BNTX.O vaccine, nearly a month after it started the evaluation process.
While European authorities have yet to approve any booster shots for coronavirus vaccines unlike their U.S. counterpart, surging cases and breakthrough infections may prompt them to take additional precautionary measures.
"Although EMA and ECDC (European Centre for Disease Prevention and Control) do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary," the EU regulator said.
The application for the Moderna vaccine, called Spikevax, has been submitted by the U.S.-based company and includes results from an ongoing trial.
Many EU countries have decided to administer a booster dose despite facing higher legal risks as there is no formal approval from the EMA, a decision the regulator thinks has merits.
<^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ FACTBOX-Countries weigh need for booster COVID-19 shots
UPDATE 1-EU drugs regulator to decide on Pfizer vaccine booster in early October
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
(Reporting by Pushkala Aripaka and Yadarisa Shabong in Bengaluru; Editing by Anil D'Silva)
((Yadarisa.Shabong@thomsonreuters.com; Twitter:
+919742735150;))
(Adds background)
(增加背景)
Sept 27 (Reuters) - The European Union's (EU) drug regulator said on Monday it was evaluating whether a booster dose of Moderna's MRNA.O COVID-19 vaccine could be given at least six months after the second shot of the two-dose course in people over 12 years of age.
路透9月27日-欧盟(EU)药品监管机构周一表示,正在评估莫德纳公司的MRNA.O新冠肺炎疫苗能否在12岁以上人群接种两针疗程的第二针后至少六个月进行加强剂量的注射。
The review by the European Medicines Agency (EMA) comes after its statement last week that it aims to decide in early October whether to endorse a booster for Pfizer-BioNTech PFE.N
欧洲药品管理局(EMA)上周发表声明称,计划在10月初决定是否支持辉瑞-BioNTech PFE.N的增强剂,之后进行了这项审查。
BNTX.O vaccine, nearly a month after it started the evaluation process.
BNTX.O疫苗,在开始评估过程近一个月后。
While European authorities have yet to approve any booster shots for coronavirus vaccines unlike their U.S. counterpart, surging cases and breakthrough infections may prompt them to take additional precautionary measures.
虽然与美国不同,欧洲当局尚未批准任何冠状病毒疫苗的强化注射,但激增的病例和突破性感染可能会促使他们采取额外的预防措施。
"Although EMA and ECDC (European Centre for Disease Prevention and Control) do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, EMA is evaluating the present application to ensure evidence is available to support further doses as necessary," the EU regulator said.
欧盟监管机构表示:“尽管欧洲疾病预防控制中心和欧洲疾病预防控制中心并不认为在普通人群中迫切需要新冠肺炎疫苗强化接种,但该机构正在评估目前的申请,以确保有证据支持必要时进一步接种。”
The application for the Moderna vaccine, called Spikevax, has been submitted by the U.S.-based company and includes results from an ongoing trial.
现代疫苗的申请名为Spikevax,已经由这家总部位于美国的公司提交,其中包括一项正在进行的试验的结果。
Many EU countries have decided to administer a booster dose despite facing higher legal risks as there is no formal approval from the EMA, a decision the regulator thinks has merits.
尽管面临更高的法律风险,但许多欧盟国家仍决定实施增强剂量,因为没有得到EMA的正式批准,监管机构认为这一决定有价值。
<^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ FACTBOX-Countries weigh need for booster COVID-19 shots
UPDATE 1-EU drugs regulator to decide on Pfizer vaccine booster in early October
更新1-欧盟药品监管机构将于10月初决定辉瑞疫苗增强剂
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
(Reporting by Pushkala Aripaka and Yadarisa Shabong in Bengaluru; Editing by Anil D'Silva)
(Pushkala Aripaka和Yadarisa Shabong在孟加拉国报道;Anil D‘Silva编辑)
((Yadarisa.Shabong@thomsonreuters.com; Twitter:
(Yadarisa.Shabong@thomsonreurs.com;推特:
+919742735150;))
+919742735150;))
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在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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