Novavax疫苗遭FDA指有導致心臟發炎風險

In Market Shorts
June 06, 2022
傳染病疫苗開發商Novavax Inc.備受矚目的COVID-19疫苗,遭美國食品藥品監督管理局(FDA)警告恐有導致心臟發炎風險,股價急跌。路透社、Investing.com、CNN等外電3日報導,FDA 3日釋出簡報指出,Novavax於2020年12月至2021年9月對將近3萬名受試者進行的臨床實驗顯示,其基於蛋白質的COVID-19疫苗可有效降低中至重症風險、接種兩劑後兩個半月內的有效度多達90.4%。不過,文件顯示,6名個案接種Novavax疫苗「NVX-CoV2373」後出現心肌炎(myocarditis)或心包炎(pericarditis)症狀,其中5名是男性、年齡介於16~67歲。這6名案例有5人住院,如今皆已康復。FDA認為,這些事件暗示心肌炎/心包炎與疫苗接種恐有因果關聯,情況類似mRNA COVID-19疫苗,要求Novavax必須標示警語。不過,Novavax尚未同意。Novavax對FDA回應指出,採樣規模只要夠大,自然會出現心肌炎案例,且年輕男性風險較高。心肌炎大都是感染不特定的病毒引發。根據該公司對本次臨床實驗數據的解讀,沒有足夠證據證實兩者間有因果關係。

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