完整标题：
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
发稿单位：
U.S. Food & Drug Administration
发稿时间：
May 19, 2021
撰 稿 者：
Tim Stenzel, M.D., Ph.D
原文连结：
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.”
大致翻译如下:
FDA认为可以用SARS-CoV-2抗体来进行辨识接触病毒历史
但FDA强烈表示抗体并不能代表免疫力或保护力(减少重症)
"尤其是使用过COVID-19之疫苗后"
结论:
想要用中和抗体去建立VE模型，看起来美国FDA是不允许的
不管疫情如何，三期的双盲测试还是必须才能理解疫苗的保护力
同时三期大量收案也可以让疫苗安全性以及潜在副作用揭露更多资讯
所以现在任何对于使用抗体推估效力的说法，都属于未被验证且无根据之言论