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BRIEF-BioNTech Says Pfizer,Co Request Regulatory Agencies Expand Emergency Use Of Their Covid-19 Vaccine To Adolescents

BRIEF-BioNTech Says Pfizer,Co Request Regulatory Agencies Expand Emergency Use Of Their Covid-19 Vaccine To Adolescents

Brief-BioNTech表示,輝瑞公司要求監管機構將其新冠肺炎疫苗的緊急使用範圍擴大到青少年
路透社 ·  2021/04/10 00:58

April 9 (Reuters) - BioNTech SE :
   * PFIZER AND BIONTECH REQUEST REGULATORY AGENCIES EXPAND EMERGENCY USE OF THEIR COVID-19 VACCINE TO ADOLESCENTS
   * REQUESTED AMENDMENTS TO U.S. EUA OF THE PFIZER-BIONTECH VACCINE TO EXPAND USE IN ADOLESCENTS 12 TO 15 YEARS OF AGE
   * REQUESTS BASED ON DATA FROM PIVOTAL PHASE 3 TRIAL IN ADOLESCENTS 12 TO 15 YEARS OF AGE WITH OR WITHOUT PRIOR EVIDENCE OF SARS-COV-2 INFECTION
   * COMPANIES PLAN TO REQUEST SIMILAR RULINGS BY OTHER REGULATORY AUTHORITIES WORLDWIDE IN COMING DAYS

Source text for Eikon:  Further company coverage:

((Reuters.Briefs@thomsonreuters.com;)

路透4月9日電-BioNTech SE:*輝瑞和BioNtech要求監管機構將其新冠肺炎疫苗的緊急使用範圍擴大至青少年*要求修改輝瑞-BioNTech疫苗的美國EUA,以擴大在12至15歲青少年中的使用*基於有或沒有SARS-COV-2感染先前證據的12至15歲青少年關鍵階段3期試驗的數據提出的請求*公司計劃在未來幾天要求全球其他監管機構做出類似裁決Eikon的源文本:進一步的公司報道:(Reurs.Briefs@thomsonreurs.com;)

譯文內容由第三人軟體翻譯。


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