美國FDA表示抗體不能驗證疫苗效力 - 股票

(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


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