美FDA警告:Novavax疫苗心肌炎風險引憂 - 股票QA

By Gilbert
at 2022-06-04T10:44
at 2022-06-04T10:44
Table of Contents
原文標題:
美FDA警告:Novavax疫苗心肌炎風險引憂 股價慘跌14%
原文連結:https://www.ettoday.net/news/20220604/2265603.htm
發布時間:2022年06月04日 10:00
記者署名:記者陳宛貞/綜合外電報導
原文內容:
美國藥廠諾瓦瓦克斯(Novavax)研發新冠疫苗NVX-CoV2373,實驗數據顯示
其可降低輕症至重症風險,5月中宣布向台灣申請緊急使用授權(EUA)。不
過美國食品藥品監督管理局(FDA)3日表示,Novavax疫苗導致心臟炎症的風
險引發憂慮,該公司股價因此下跌14%。
《路透》報導,Novavax公司2020年12月至2021年9月進行3萬人實驗,注射疫
苗後20天內出現4起心肌炎個案。FDA於3日發布簡報文件指出,這些案例與疫
苗的因果關係令人憂心,並要求Novavax將心肌炎及心包膜炎列為該疫苗的「
重要已知風險」,不過該公司並未同意列入。
FDA文件曝光後,Novavax公司股價下跌近14%。該公司對此則回應,臨床實驗
出現的心肌炎個案數量在預期範圍內,「基於我們對所有支持NVX-CoV2373疫
苗臨床數據的解釋,我們認為沒有足夠的證據證明兩者之間存在因果關係」,
試驗中也有一名患者接種安慰劑後出現心肌炎。
另一方面,FDA此次分析Novavax疫苗在Omicron及Delta變種成為主流毒株以前
的試驗數據,結果指出,該疫苗對Omicron引起的感染提供有意義的防護,尤
其可降低重症風險。
心得/評論:
1) FDA希望把心肌炎納入該疫苗的"重要已知風險",公司不同意
2) 孿生技術的高端還有未來嗎?
--
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