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July 22, 2021
Uncategorized

FDA批准強生疫苗期限延長6週 至4個半月

強生公司(Johnson & Johnson) 週四表示,美國監管機構將數百萬劑 COVID-19 疫苗的有效期延長了六週時間。

強生公司表示,食品和藥物管理局FDA的一項審查得出結論,這些疫苗針劑在至少 4 個半月內仍然安全有效。

FDA 最初授權強生的疫苗在正常冷藏水平下儲存長達三個月。週四宣布這一消息之前,州官員警告說,許多儲存的劑量將在本月底之前到期。

強生表示,根據正在進行的評估疫苗穩定性的研究數據,FDA 增加了六週時間。

FDA一直在審查全美所有三種授權疫苗的有效期,因為公司在首次推出疫苗後的幾個月裡繼續測試批次。

輝瑞和 Moderna 的疫苗於 12 月獲得批准,保質期為 6 個月。

先前有報導表示,強生至今為美國生產的2100萬劑疫苗,將近一半都未使用;有至少13批最晚將在6月27日到期,但是不清楚劑量數。

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