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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

輝瑞/生物科技為11歲以下兒童更新新冠肺炎疫苗尋求FDA緊急批准
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.

  • 輝瑞(紐約證券交易所股票代碼：PFE)和BioNTech SE納斯達克(納斯達克股票代碼：BNTX)已經完成了向美國食品和藥物管理局提交的奧密克戎BA.4/BA.5改編的雙價新冠肺炎疫苗的緊急使用授權，該疫苗用於5至11歲的兒童，劑量為10 Gb g加強劑。

  • 奧密克戎BA.4/BA.5適應二價疫苗在該年齡段的緊急使用請求得到了來自兩家公司的奧密克戎BA1二價適應疫苗的安全性和免疫原性數據、非臨牀和生產數據以及臨牀前數據的支持。

  • 相關內容: 歐洲支持批准奧密克戎改裝的新冠肺炎疫苗.

  • 將奧密克戎BA.4/BA.5適應的雙價疫苗擴展到5-11歲兒童的申請將在未來幾天內提交給歐洲藥品管理局(EMA)。

  • 兩家公司還啟動了一項1/2/3期研究，以評估不同劑量和劑量方案的輝瑞/生物技術奧密克戎BA.4/BA.5適應的新冠肺炎疫苗在6個月至11歲兒童中的安全性、耐受性和免疫原性。

声明：本內容僅用作提供資訊及教育之目的，不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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