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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

更新1-歐盟審查現代納新冠肺炎助推器注射的數據
reuters ·  2021/09/27 11:20

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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-歐盟(EU)藥品監管機構週一表示,正在評估莫德納公司的MRNA.O新冠肺炎疫苗能否在12歲以上人羣接種兩針療程的第二針後至少六個月進行加強劑量的注射。

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

歐洲藥品管理局(EMA)上週發表聲明稱,計劃在10月初決定是否支持輝瑞-BioNTech PFE.N的增強劑,之後進行了這項審查。

BNTX.O vaccine, nearly a month after it started the evaluation process.

BNTX.O疫苗,在開始評估過程近一個月後。

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.

雖然與美國不同,歐洲當局尚未批准任何冠狀病毒疫苗的強化注射,但激增的病例和突破性感染可能會促使他們採取額外的預防措施。

"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.

歐盟監管機構表示:“儘管歐洲疾病預防控制中心和歐洲疾病預防控制中心並不認為在普通人羣中迫切需要新冠肺炎疫苗強化接種,但該機構正在評估目前的申請,以確保有證據支持必要時進一步接種。”

The application for the Moderna vaccine, called Spikevax, has been submitted by the U.S.-based company and includes results from an ongoing trial.

現代疫苗的申請名為Spikevax,已經由這家總部位於美國的公司提交,其中包括一項正在進行的試驗的結果。

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.

儘管面臨更高的法律風險,但許多歐盟國家仍決定實施增強劑量,因為沒有得到EMA的正式批准,監管機構認為這一決定有價值。

<^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ 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-歐盟藥品監管機構將於10月初決定輝瑞疫苗增強劑

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(Reporting by Pushkala Aripaka and Yadarisa Shabong in Bengaluru; Editing by Anil D'Silva)

(Pushkala Aripaka和Yadarisa Shabong在孟加拉國報道;Anil D‘Silva編輯)

((Yadarisa.Shabong@thomsonreuters.com; Twitter:

(Yadarisa.Shabong@thomsonreurs.com;推特:

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