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Pfizer/BioNTech Seek FDA Emergency Nod For Updated COVID-19 Shot For Kids Under 11 Years

Pfizer/BioNTech Seek FDA Emergency Nod For Updated COVID-19 Shot For Kids Under 11 Years

辉瑞/生物科技为11岁以下儿童更新新冠肺炎疫苗寻求FDA紧急批准
Benzinga Real-time News ·  2022/09/26 07:54

  • Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have completed an FDA submission seeking Emergency Use Authorization (EUA) for a 10-μg booster dose for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

  • The emergency use request of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies' bivalent Omicron BA.1-adapted vaccine, non-clinical & manufacturing data, and pre-clinical data.

  • Related Content: Europe Backs Approval Of Omicron-Adapted COVID-19 Vaccines.

  • An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine for 5-11 years children will be submitted to the European Medicines Agency (EMA) in the coming days.

  • The companies have also initiated a Phase 1/2/3 study to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of Pfizer/BioNTech's Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children six months - 11 years.

  • 辉瑞(纽约证券交易所股票代码：PFE)和BioNTech SE纳斯达克(纳斯达克股票代码：BNTX)已经完成了向美国食品和药物管理局提交的奥密克戎BA.4/BA.5改编的双价新冠肺炎疫苗的紧急使用授权，该疫苗用于5至11岁的儿童，剂量为10 Gb g加强剂。

  • 奥密克戎BA.4/BA.5适应二价疫苗在该年龄段的紧急使用请求得到了来自两家公司的奥密克戎BA1二价适应疫苗的安全性和免疫原性数据、非临床和生产数据以及临床前数据的支持。

  • 相关内容: 欧洲支持批准奥密克戎改装的新冠肺炎疫苗.

  • 将奥密克戎BA.4/BA.5适应的双价疫苗扩展到5-11岁儿童的申请将在未来几天内提交给欧洲药品管理局(EMA)。

  • 两家公司还启动了一项1/2/3期研究，以评估不同剂量和剂量方案的辉瑞/生物技术奥密克戎BA.4/BA.5适应的新冠肺炎疫苗在6个月至11岁儿童中的安全性、耐受性和免疫原性。

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