完整標題：
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
發稿單位：
U.S. Food & Drug Administration
發稿時間：
May 19, 2021
撰 稿 者：
Tim Stenzel, M.D., Ph.D
原文連結：
https://tinyurl.com/34znv66p
“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強烈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"
結論:
想要用中和抗體去建立VE模型，看起來美國FDA是不允許的
不管疫情如何，三期的雙盲測試還是必須才能理解疫苗的保護力
同時三期大量收案也可以讓疫苗安全性以及潛在副作用揭露更多資訊
所以現在任何對於使用抗體推估效力的說法，都屬於未被驗證且無根據之言論