Novavax Inc. 疫苗傳純度未達標 ,恐怕拖至明年底核准

In Market Shorts
October 21, 2021

Novavax Inc. 疫苗傳純度未達標 ,恐怕拖至明年底核准

美國傳染病疫苗生技開發商Novavax Inc.因市場謠傳其疫苗的製造品質問題比先前預期嚴重,股價一度大跌24%。Politico 於10月19日引述未具名消息人士報導,Novavax在證明其新冠肺炎(COVID-19)候選疫苗能符合主管機關品質標準時,面臨嚴重挑戰。報導直指,Novavax的「問題比之前大家理解的還要令人擔憂」,預測明(2022)年底前製造問題才有解,屆時才能贏得主管機構的授權、核可。報導指出,世界衛生組織(WHO)支持的新冠肺炎疫苗全球獲取機制(COVAX),原定要在明年底為中低收入國家提供超過20億劑疫苗,如今卻可能因為Novavax面臨製造挑戰,使整體供應量較目標短少超過10億劑。報導引述消息人士直指,Novavax用來測試疫苗純度的方法,並未達到主管機關要求的標準,該公司無法證明產出的疫苗能穩定達標。根據報導,美國食品藥品監督管理局(FDA)會依據2020年6月制定的新冠疫苗指導原則,針對每家廠商設定純度標準,一般是要求每批疫苗的純度至少需達90%。然而,熟知製程的消息人士直指,Novavax最近製出的疫苗純度僅70%左右。低純度會增加最終製品受到汙染或含有非必要物質的風險,進而降低疫苗有效度,未知物質也可能讓接種者產生不良反應。

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