(FDA這篇是在說抗體檢測不能判斷免疫能力或本身對病毒的抗性)
原文標題：
FDA In Brief: FDA Advises Against Use of SARS-CoV-2 Antibody Test Results to
Evaluate Immunity or Protection From COVID-19, Including After Vaccination
原文連結：
https://tinyurl.com/34znv66p
發布時間：
May 19, 2021
原文內容：
“The FDA is reminding the public of the limitations of COVID-19 antibody, or
serology, testing and providing additional recommendations about the use of
antibody tests in people who received a COVID-19 vaccination.
Antibody tests can play an important role in identifying individuals who may
have been exposed to the SARS-CoV-2 virus and may have developed an adaptive
immune response. However, antibody tests should not be used at this time to
determine immunity or protection against COVID-19 at any time, and especially
after a person has received a COVID-19 vaccination.
The FDA will continue to monitor the use of authorized SARS-CoV-2 antibody
tests for purposes other than identifying people with an adaptive immune
response to SARS-CoV-2 from a recent or prior infection.”
大致翻譯如下
FDA認為可以用SARS-CoV-2抗體來進行辨識接觸病毒歷史
但FDA表示抗體並不能代表免疫力或保護力(減少重症)
"尤其是使用過COVID-19之疫苗後"
(雖然這是常識啦XDDDD)
心得/評論：
該篇宣告和國產疫苗本身只有中和抗體數據沒絕對關係
國產疫苗二期只有中和抗體效價的數據 (補充，中和抗體和總抗體是不同的東西)
也就是說，依照此數據推估出來的效力或是保護力，都無法經過檢驗或承認
所以上至高官或抗疫英雄，下至人體受試者或網拍業者
說國產疫苗二期數據好棒棒效力一定很棒的都是未經過驗證說法
(我原本說是謠言，經過版友指正認為帶有情緒且容易誤導為無效，這邊修正)
沒有三期雙盲測試的數據根本無法談效力，美國FDA也不會承認
用抗體想去建立VE模型? 目前是沒有任何學理上的支持
一個沒有效力數據的疫苗要怎麼進行戰略調度呢?
至於出口，就不用說了