Re: [新聞] 疫苗製造商Novavax再度延後向美國申請EUA

作者: Aqqqa (Aqqqa)   2021-08-11 10:15:17
※ 引述《deathdecay (VOID)》之銘言:
: 經濟日報
: 編譯洪啟原/綜合外電
: Novavax執行長爾克(Stanley Erck)說:「要讓所有的製造、分析、疫苗效力及純度檢
: 驗都保持一致、合格且合規,這是耗時的過程。」
: 爾克表示,預計第4季呈交兩劑式疫苗的EUA資料給美國食品藥物管理局(FDA)。Novavax
: 先前已把這個時程延從第2季延至第3季。
主要是美國政府下令停止在美國製造Novavax, 除非品管都一致, 且通過FDA認證
https://reurl.cc/2rR3vO
節錄自Science
Novavax, the small, Maryland-based company that has been struggling for
months to bring its promising protein-based COVID-19 vaccine to market,
announced a setback yesterday in its quest for an emergency use authorization
(EUA) in the United States, sending its share prices tumbling today. The U.S.
government has ordered Novavax to stop making vaccine in the United States
and said it will offer the company no more manufacturing funding until it
passes muster with the Food and Drug Administration’s (FDA’s) strict
manufacturing requirements, such as ensuring each lot of vaccine has the same
potency.
美國很多家新聞媒體都有寫
因為各批次品質不穩定
所以退回EUA申請 且嚴格要求品質的穩定
我們高端雖是系出同門
但一定青出於藍
所以火速通過EUA

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