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July 22, 2021
Uncategorized

FDA發布會議報告及新冠疫苗接種指南

輝瑞公司和生物技術公司已經宣布,他們的新冠疫苗在三期實驗中獲得成功。FDA工作人員在今天發布的一份報告中稱,該疫苗的功效數據符合緊急使用授權的預期。專家們將討論是否建議16歲及以上人群注射輝瑞疫苗。

在這份長達53頁的報告中,文件顯示,輝瑞公司在疫苗的後期試驗中共有6人死亡,其中2人在接種疫苗的患者中死亡,其餘是在服用安慰劑的患者中死亡。但FDA的工作人員表示,這些死亡事件都以相似的速度在普通人群中發生。

報告還發現,目前沒有足夠的數據來對16歲以下的人、孕婦和免疫系統受損的人作出疫苗安全性的結論。

今天一個由獨立科學家組成的小組對FDA的首次通過審查進行甄別,然後再就疫苗是否對數百萬美國人安全有效提出建議。食品和藥物管理局通常遵循委員會的建議,預計將在審查後的幾天內作出決定。如果獲得批准,根據各州制定的計劃,首批受助者將是醫療工作者和療養院居民。

17日FDA將審核莫德納的新冠疫苗。疫苗計畫官員表示,本週結束前將開始發放290萬劑疫苗提供施打。

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