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July 22, 2021
Uncategorized

輝瑞今提交新冠疫苗緊急使用授權申請

輝瑞與德國BioNTech 20日共同宣布,已向食品藥品監督管理局(FDA)提交mRNA新冠疫苗BNT162b2的緊急使用權申請,該疫苗有望於今年12月中旬至年底前在全美的高危人群中使用。

兩天前,兩家公司曾宣布,合作研發的新冠疫苗有效率達到95%,且沒有發現嚴重的安全隱患。此次緊急使用權申請也正基於該研究數據。除了在美國提交緊急使用權的申請,兩家公司還在全球啟動了滾動申請,包括澳洲、加拿大、歐洲、日本、英國等國家和地區。

同時,輝瑞和BioNTech還打算在未來幾天向全球其他監管機構提交申請。兩家公司表示,預計到2020年全球將生產多達5000萬劑疫苗,到2021年將生產多達13億劑疫苗,並將在獲得批准後的幾個小時內開始分發疫苗。

傳染病專家福奇博士(Anthony Fauci)表示,疫苗可以在明年4月或7月之前向所有美國人提供。約翰霍普金斯大學彙編的數據顯示,新冠病毒繼續在全美迅速蔓延,截至週五,已有超過171萬人感染了這種病毒,至少25.2萬人死亡。

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