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May 21, 2025
美國要聞

FDA不再常規性批準健康人群接種新冠疫苗

川普政府週二公佈一項重大政策調整,健康的兒童和年輕人今後將不再例行獲得年度 COVID-19 疫苗接種批准。

根據食品藥品監督管理局(FDA)最新發布的框架,65 歲及以上的老年人及患有潛在健康問題的高風險人群仍將優先獲得疫苗。而對健康群體,企業必須提供長期臨床研究數據,才能獲得批准。

FDA 此舉引發質疑,專家擔心這可能會降低疫苗的可獲得性和保險覆蓋率。疫苗專家奧菲特醫生表示,新政也模糊了由誰決定個體是否屬於高風險人群的標準。

此次指南由FDA局長馬卡里(Marty Makary)和疫苗負責人普拉薩德(Vinay Prasad)撰寫,批評美國「一刀切」的疫苗推薦方式,並指出與歐洲相比,美國疫苗推廣力度過強。

該政策的出臺也凸顯了現任衛生部長小肯尼迪對疫苗政策的批評立場。FDA已將該指南作為草案公佈,並開放公眾評論。

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