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July 22, 2021
Uncategorized

FDA計畫宣布嚴格標準 疫苗恐難大選前上市

聯邦食品暨藥物管理局(FDA)傳出考慮收緊新冠疫苗緊急授權新標準,最快在本周公布,這表示新疫苗要在11月3日選舉日前獲准恐相當困難。

據報導,FDA正研究兩種要求向藥廠批出疫苗緊急許可的方案,將令疫苗可能最早要到11月底的感恩節才獲批。第一個方案是FDA將要求藥廠向所有臨床試驗者注射第二劑疫苗後2個月才可申請緊急許可,第二個方案是一半試驗者注射第二劑後2個月才可申請。

知情者稱,FDA憂慮新冠肺炎疫苗只提供短期免疫,2個月門檻可讓當局更容易預測相關疫苗能否產生長期免疫反應,指引會要求FDA更全面地跟進接種緊急授權疫苗人士的情況。指引亦會列出生產及測試疫苗的建議標準,確保疫苗安全。

美國藥廠輝瑞、Moderna及英國藥廠阿斯利康(AstraZeneca)均在美國展開疫苗臨床試驗,其中輝瑞及Moderna的疫苗處於第三階段,它們的疫苗均分為兩劑。輝瑞的臨床試驗者為4.4萬人,至周一有19,210人注射第二劑,不足一半人;Moderna則有3.3萬名試驗者,至上周五有11,879人接種了第二劑,亦未夠一半人。

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