Matta, M. K., Zusterzeel, R., Pilli, N. R., Patel, V., Volpe, D. A., Florian, J., … & Kemp, S. (2019). Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial. Jama, 321(21), 2082-2091.
相較於過去的臨床試驗,這次新冠疫情造成的社會經濟影響與傷亡人數皆十分巨大,而疫苗研發在這段期間,也比往常來得更快。因此,有些疫苗在開始施打後,才發現其他安全性上的問題,例如 AZ 跟嬌生在上市後,才發現有些施打者出現了血栓 Thrombosis with Thrombocytopenia Syndrome(TTS)反應。
不過,未來 T 淋巴球的相關指標,可能會是免疫橋接的重要指標。目前市面上的新冠疫苗,皆是設計成對抗最原始的病毒株,而在新冠肺炎流行一年多的現在,病毒也產生了變種,這導致施打疫苗後所產生的抗體,對於變種病毒的中和效果變差。但是,T 淋巴球的功能卻沒有減弱,因此 T 淋巴球被認為在對抗變種病毒中扮演重要角色。
在衛福部公布的「COVID-19 疫苗緊急使用授權審查標準」中的「療效評估標準」提到,國產疫苗的有效性評估是使用免疫橋接來確認,將國產疫苗所產生的抗體濃度與 AZ 疫苗做比較,然此條件僅考慮中和抗體。另外,在「疫苗專家審查會議」的會議紀錄中提及,高端疫苗臨床二期試驗數據,並未包含相關 T 淋巴球及變種病毒株之相關資訊,因此疫苗有效性尚待更多驗證 [23]。
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但是要創造出長久的價值,就不像表面那麼容易了。二○○六年接管這家公司時,這位年輕的執行長立刻複習一遍他的企管碩士教戰守冊—積極尋找收購和結盟的機會。但就算他成功地製造出話題,根據《亞洲貨幣》(AsiaMoney)的說法,蘭伯西的損益表底線卻在「下降中」。蘭伯西不得不撤回收購德國最大學名藥公司的那場標案。後來又碰 FDA 的作梗。在他看來,美國的監管機關真的「很討人厭」,不管他怎麼保證公司一定會改革,怎麼暗示它們為這家公司留點面子,對方就是無動於衷。
但在美國,你召集不到自衛部隊,而且 FDA 也拒絕讓步。身為蘭伯西最大股東的辛格兄弟發現這些問題已經有損他們的損益表底線。但就在這些紛擾當中,馬爾溫德注意到紐約有家公司的顧問傳了一則很有趣的訊息給他。日本製藥公司第一三共(Daiichi Sankyo)裡一個叫做宇根勉(Tsutomu Une,暫譯名)的傢伙想跟他談一下策略合夥的事。馬爾溫德嗅到了商機。
但是宇根勉仍有一些懸而未決的疑問。眾所皆知聯邦探員曾在二月突襲蘭伯西的美國總部,發出警告函抵制它的兩家主要工廠:帕奧恩塔薩希布和德瓦斯。但是沒有人知道這場調查的嚴重性究竟到什麼程度,或者這家公司的可能法律責任。馬爾溫德曾在電話裡詢問宇根勉:「你在擔心什麼?」宇根勉只能自行揣測美國司法部底下的檢察官和這世上最難纏的 FDA 監管人員到底在追查什麼。這是他的顧問們必須找到的答案。不到一個月,馬爾溫德和宇根勉在德里祕密會面,雙方都各自帶著律師和一小群高級主管。宇根勉明白表示,不管美國政府對蘭伯西進行的各種調查最後會查出什麼,都會影響第一三共的未來動作。但馬爾溫德表情淡定,保證會提供協助,對整個過程坦誠以對。他同意辦一場盡職調查會(due diligence meeting),將所有跟調查案有關的文件全攤在第一三共面前。