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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,辉瑞公司要求监管机构将其新冠肺炎疫苗的紧急使用范围扩大到青少年
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日电-BioNTech SE:*辉瑞和BioNtech要求监管机构将其新冠肺炎疫苗的紧急使用范围扩大至青少年*要求修改辉瑞-BioNTech疫苗的美国EUA,以扩大在12至15岁青少年中的使用*基于有或没有SARS-COV-2感染先前证据的12至15岁青少年关键阶段3期试验的数据提出的请求*公司计划在未来几天要求全球其他监管机构做出类似裁决Eikon的源文本:进一步的公司报道:(Reurs.Briefs@thomsonreurs.com;)

译文内容由第三方软件翻译。


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