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UPDATE 1-Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

UPDATE 1-Pfizer, BioNTech seek U.S. emergency nod for COVID-19 vaccine in adolescents

更新1-辉瑞,BioNtech寻求美国紧急批准青少年使用新冠肺炎疫苗
路透社 ·  2021/04/10 01:22

(Adds background)
   April 9 (Reuters) - Pfizer Inc and its German partner BioNTech SE said on Friday they have requested the U.S. Food and Drug Administration to expand the emergency use of their COVID-19 vaccine in adolescents aged 12 to 15.
   In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.
   Whether COVID-19 vaccines work and are safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step toward reaching "herd immunity" and taming the pandemic, according to experts.
   The companies plan to request similar rulings by other regulatory authorities globally in the coming days.
   The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.

(Reporting by Mrinalika Roy in Bengaluru; Editing by
Ramakrishnan M.)
((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;)

(增加背景)路透4月9日电-辉瑞(Pfizer Inc.)及其德国合作伙伴BioNTech SE周五表示,他们已要求美国食品和药物管理局(FDA)扩大其新冠肺炎疫苗的紧急使用范围,适用于12至15岁的青少年。今年3月,制药商表示,在一项临床试验中,该疫苗被发现是安全、有效的,并在12至15岁的儿童中产生了强大的抗体反应。新冠肺炎疫苗是否有效,对儿童是否安全,是制药商试图回答的一大问题。根据专家的说法,为儿童和年轻人接种疫苗被认为是实现“群体免疫力”和驯服疫情的关键一步。两家公司计划在未来几天要求全球其他监管机构做出类似的裁决。辉瑞/BioNTech双针疫苗已经获准在16岁以下的人群中使用。(Mrinalika Roy在孟加卢市报道;编辑者:Ramakrishnan M.)(mrinalika.roy@thomsonreurs.com;在美国境内+1 646 2238780,美国境外+91 806749 8325;)

译文内容由第三方软件翻译。


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