[問卦] 台灣超前以中和抗體為疫苗保護力指標

作者: JasperChang (PeterChou)   2021-06-13 22:49:02
剛剛滑 FB, 發現滿多人在瘋傳
https://www.nature.com/articles/s41591-021-01377-8
大意就是中和抗體效價跟保護力正相關 讚讚 (Published: 17 May 2021)
美國 FDA 認為目前不能當保護力參考 (Date Issued: May 19, 2021)
results from currently authorized SARS-CoV-2 antibody tests should not be
used to evaluate a person's level of immunity or protection from COVID-19 at
any time, and especially after the person received a COVID-19 vaccination.
https://reurl.cc/7rpx3y
嘛,WHO 也還在爭議並研究這點,
也有其他研究者嘗試歸納其他變因 (Published: 09 June 2021)
https://www.nature.com/articles/s41586-021-03681-2
抗體可能不是決定保護力的單一因素, 像 T cells (May 27, 2021)
https://reurl.cc/LbMGea
不過中和抗體也並非真的不可取, 美國 FDA 有討論擴大讓低齡施打 (June 10, 2021)
(前提: 成人有效, 臨床反應可能有差兼不適合對小屁孩試驗, 所以考慮用非劣試驗)
neutralizing antibodies can serve as a biomarker to infer COVID-19 vaccine
effectiveness in pediatric populations via immunobridging. Because no
specific neutralizing antibody titer has yet been established to predict
protection, rigorous immunobridging studies would compare the range of
neutralizing antibody responses in adult vs. pediatric populations by
evaluating both seroresponse rates...
https://www.fda.gov/media/149935/download
當全球正在實驗辯證那些指標可以做為保護力參考時
獨步世界的台灣 FDA 率先發難 (發布日期:2021-06-10)
研商以免疫橋接(immuno-bridging)方式,採用免疫原性(中和抗體)作為替代療效指標,
衡量國產疫苗誘發產生的免疫原性結果是否與國人接種國外已核准EUA的疫苗相當,
作為支持國產疫苗療效的佐證。
https://www.fda.gov.tw/TC/newsContent.aspx?cid=4&id=t600385
Google 一下不少醫療專區也超挺這個政策
這是否再次讓全世界看到台灣優秀的超前部署了?

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