The company has tested the BA.5-specific vaccine only on mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorization.
In the study, eight mice that were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original vaccine generated an immune response.
“To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows,” said John Moore, a vaccine and virology expert at Weill Cornell Medicine in New York. “It doesn’t mimic the human situation,” where many people were vaccinated more than a year ago and have since been boosted.
原文：这次辉瑞疫苗针对BA5的加强针没有进行人体临床，数据来自八只小白鼠，它们之前没有打过辉瑞疫苗。
因为mRNA疫苗第四针接种者人数下降，所以白宫，FDA和CDC准备大力推广。
这次辉瑞疫苗针对BA5的加强针没有进行人体临床，数据来自八只小白鼠，它们之前没有打过辉瑞疫苗。
The only data we''ve seen for the BA.5 booster so far is in mice (N=8)
The monovalent (BA.5 only) induced twice the level of neutralizing antibodies than bivalent (BA.5 + original)
(The mice didn''t get 3 or 4 prior shots with original vaccine)
https://fda.gov/media/159496/download
因为太过离奇，文章给出了链接，我核实了一下
第一张截图，显示的是Omicron 单价和双价疫苗在55岁以上（分别注射30和50 ug) 抗体反应
第二张截图，显示动物实验结果。注意说明中 similar to clinical data，意思是说，跟临床实验数据相似。没有临床数据何来相似？
这些阴谋论经常就是欺负很多人不懂英语·或者不会去看原文。上述资料来自发帖者自己提供的数据连接
1. 柳叶刀文章发表于2020年，那时Covid疫苗还在研究，文章只是提出一个假设，没有任何数据
2. 文章担心的原因是之前有一款腺病毒载体为基础的HIV疫苗在实验测试阶段（不是使用后发现的）有可能增加HIV感染危险
3.这感染危险不是疫苗本身，是生产疫苗的病毒载体
4. 柳叶刀文章发表时，有些处于研究阶段的Covid 疫苗同样使用腺病毒载体，所以研究者担心会出现类似的问题
5.mRNA疫苗不需要腺病毒载体，不存在这个危险
美国批准使用的疫苗没有听说过有这个问题
里面的Bivalent是原始毒株+BA1，根本不是原始毒株+BA5。这里经常见到不少七窍只通六窍的大肆攻击别人的科普文，给人戴帽子说什么阴谋论，反疫苗。。。
1）你说的阴谋论文字来自于这位医生，他本身非常支持疫苗：
https://twitter.com/EricTopol/status/1562455444714426370?
2）https://www.usatoday.com/story/news/health/2022/08/22/pfizer-covid-booster-omicron-submitted-fda-emergency-authorization/7844312001/
The company has tested the BA.5-specific vaccine only on mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorization.
In the study, eight mice that were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original vaccine generated an immune response.
“To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows,” said John Moore, a vaccine and virology expert at Weill Cornell Medicine in New York. “It doesn’t mimic the human situation,” where many people were vaccinated more than a year ago and have since been boosted.
3）https://www.npr.org/sections/health-shots/2022/08/18/1117778748/whats-behind-the-fdas-controversial-strategy-for-evaluating-new-covid-boosters?utm_campaign=storyshare&utm_source=twitter.com&utm_medium=social
For the first time, the FDA is planning to base its decision about whether to authorize new boosters on studies involving mice instead of humans.
临床数据。Pfizer用于证明OMI BA.4/5疫苗有效的数据确实只是8只实验老鼠的数据（看最后的两张图表）。
文中几次提到Clinical data,但仔细看那些都不是感染率/重症率/死亡率这些FDA Clinical trial所考察的临床数据，而是中和抗体滴度和中和反应等等这些实验室数据。唯一与临床有关的数据是文中提到的“接种后一个月没被感染”，可结合前面的资料，那些病人接种的是不同剂量的OMI BA.1疫苗，而不是BA.4/5疫苗。文章开始时提到不同剂量的单价双价疫苗时，图表很清楚地注明是OMI BA.1疫苗，可后来的数据就把BA.1抹掉了，都统称为OMI单价双价疫苗。个人感觉Pfizer在这里玩文字游戏，混淆有关的概念。
你上面引用的两个图表中，上方标记的BA.1和BA.4/5（第一个图）和Reference strain，Omicron BA.1, Omicron BA.4/5(第二个图），这些指的都是COVID病毒的不同的变异病毒株（株=strain），而不是指疫苗。这两张图都显示不同的变异病毒对不同疫苗（在图的下方）的反应区别。
我感觉这些为支持Pfizer OMI BA.4/5新疫苗的数据中，名词/定义混乱，本应该是BA.4/5疫苗的资料，可看到的都是遮遮掩掩的BA.1疫苗的数据。本来基本上都是实验室数据，可又加上了个Clinical data。
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-use