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
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;)
(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日電-輝瑞(Pfizer Inc.)及其德國合作伙伴BioNTech SE週五表示，他們已要求美國食品和藥物管理局(FDA)擴大其新冠肺炎疫苗的緊急使用範圍，適用於12至15歲的青少年。今年3月，製藥商表示，在一項臨牀試驗中，該疫苗被發現是安全、有效的，並在12至15歲的兒童中產生了強大的抗體反應。新冠肺炎疫苗是否有效，對兒童是否安全，是製藥商試圖回答的一大問題。根據專家的説法，為兒童和年輕人接種疫苗被認為是實現“羣體免疫力”和馴服疫情的關鍵一步。兩家公司計劃在未來幾天要求全球其他監管機構做出類似的裁決。輝瑞/BioNTech雙針疫苗已經獲准在16歲以下的人羣中使用。(Mrinalika Roy在孟加盧市報道；編輯者：Ramakrishnan M.)(mrinalika.roy@thomsonreurs.com；在美國境內+1 646 2238780，美國境外+91 806749 8325；)
譯文內容由第三人軟體翻譯。
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