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July 22, 2021
Uncategorized

輝瑞:計劃11月底申請疫苗緊急使用授權

輝瑞製藥公司(Pfizer)週五表示,該公司可能會在11月下旬與德國合作夥伴生物科技公司(BioNTech)為正在研發的新冠疫苗申請批准,這使得該疫苗不太可能像總統特朗普承諾的那樣,在美國大選前上市。

輝瑞表示,一旦它們與德國生物科技公司BioNTech SE合力研發的新冠病毒疫苗在11月第三星期,達到食品藥品監督管理局(U.S. Food and Drug Administration,FDA)對疫苗的要求,它們將為疫苗申請緊急使用權。路透社報導,FDA表示,在授權緊急使用任何實驗性新冠病毒疫苗之前,其測試公司必須掌握至少兩個月的安全數據。

輝瑞首席執行官阿爾伯特·布爾拉(Albert Bourla)在一份聲明中說,「基於我們目前的試驗入組和給藥速度,預估將在11月份的第三周達到這一里程碑。」輝瑞稱,即使在早期階段宣布有效,也會繼續進行試驗,直到通過最後的分析點。這意味,疫苗將不會在美國總統大選之前上市。

輝瑞是在美國進行新冠疫苗後期臨床試驗的四家公司之一,其餘三家公司包括莫德納(Moderna)、阿斯利康(AstraZeneca)和強生(Johnson & Johnson)表示,今年年底的可能性更大,與聯邦衛生官員的預測相符。

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