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July 22, 2021
Uncategorized

FDA批准12-15歲打輝瑞疫苗 降低校園染疫風險

聯邦食品暨藥物管理局(FDA)10日批准輝瑞與BioNTech新冠疫苗,在美國的接種對象擴大至12至15歲青少年;此舉將可在全國青少年秋季返校前提供保護。

FDA的批准可望降低開學後教室內病毒傳播的威脅,還有機會讓數百萬名青少年參加夏令營,與朋友一起相聚或過夜。

不過FDA的批准並非最後一道關卡,聯邦疾病防治中心(CDC)諮詢委員會預計很快評估相關數據,提供12至15歲青少年接種疫苗的建議;若該委員會如預期支持輝瑞疫苗為該年齡層接種,基本上便可即刻開打。

在臨床試驗中,輝瑞與BioNTech徵求2,260名12至15歲的參與者,間隔三周接種兩劑疫苗或安慰劑;研究人員表示,安慰劑組18人確診且無症狀,疫苗組則無人確診,這顯示輝瑞疫苗具高度有效預防新冠疾病。以副作用而言,相較於16至25歲的試驗參與者,輝瑞疫苗似乎對12至15歲族群更安全。

輝瑞3月展開5至11歲孩童接種疫苗的試驗,4月進一步延伸試驗至2至5歲幼童,接下來擬將試驗對象年齡降低至6個月至2歲。

莫德納為12至17歲青少年接種疫苗的試驗結果可望在近幾周出爐。

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