During that initial placebo period, the document reports that the infection rate of this group was “12.6 cases per 1,000 person-years,” which equates to a 1.3% infection rate. Following their injections, there were “43.4 cases per 1,000 person- years” or a 4.34% infection rate.
“So, when they weren’t injected, their infection rate was 1.3%, and when they got injected, it was 4.34%. It went up by over 300%,” Kingston observed. “That 300% increase is a correlation, it’s not an anomaly.”
这个报告所使用的数据主要是对这些辉瑞疫苗实验人群中没有感染新冠的人员，进行的在delta爆发期间感染情况的分析。因此，分组情况仍然跟原来的一样，1组是从一开始就打了辉瑞疫苗的，participants who completed the 2-dose primary series early in the study，（originally randomized to BNT162b2）；一组是开始是placebo组 ，后来crossed over到BNT162b2的，those who completed the 2-dose primary series later in the study (i.e., those who were originally randomized to placebo and then crossed over to BNT162b2)。
结果1），在delta疫情期间，第一组是70.3 cases per 1,000 person-years，而第二 组是51.6 cases per 1,000 person-years，可见，由于第二组打疫苗时间更迟，其对 delta的保护作用更好。
结果2），也是谣言传出来的地方，让我们先来看看原文怎么写的。
The reported incidence of COVID-19 among study participants who completed the primary series <4 months="" prior="" to="" the="" start="" of="" the="" analysis="" period="" was="">43.4 cases per 1,000 person years.
对于那些原先在placebo组，但是在7月1号前4个月内打了疫苗的人，他们(在7月1日到8月31日之间)的感染率为43.4 cases per 1,000 person years.括号里面内容是我加的 ，要说明清楚这是在分析这些人在delta爆发期间，疫苗的防范效果。
In contrast, during the blinded, placebo-controlled follow-up period of the study with data cutoff of March 13, 2021 (prior to the Delta variant surge), the incidence of COVID-19 among BNT162b2 recipients in the Evaluable Efficacy Population (nearly 60% of whom had 4 months or more of blinded follow-up post-Dose 2) was 12.6 cases per 1,000 person-years.
This observation suggests that while waning immunity is one potential factor that may have contributed to the higher incidence breakthrough cases during the Delta variant surge, it is possible that other factors (e.g., dynamics of Delta variant transmission and potential differences in vaccine effectiveness against the Delta variant vs. strains circulating during the placebo-controlled portion of the trial) may also have contributed.
6.4.6. COVID-19 cases among C4591001 study participants during the Delta variant surge Responding to an FDA request, Pfizer performed a post hoc analysis of protocol-specified COVID-19 cases accrued during the period of July 1, 2021 through August 31, 2021 (corresponding to the Delta variant surge) among participants 16 years of age and older who completed the 2-dose primary series. The analysis compared rates of COVID-19 among participants who completed the 2-dose primary series early in the study (i.e., those who were originally randomized to BNT162b2) vs. those who completed the 2-dose primary series later in the study (i.e., those who were originally randomized to placebo and then crossed over to BNT162b2). Study participants included in the analysis were those who remained at risk for first occurrence of COVID-19 following the BNT162b2 primary series (i.e., participants who previously reported COVID-19 or who received additional study vaccinations after the primary series were excluded). The analysis used data extracted on September 2, 2021 from the study’s live database; the datasets were not submitted to FDA.
Although not independently verified by FDA, the post hoc analysis appears to indicate that the incidence of SARS-CoV-2 during the analysis period among 18,727 study participants originally randomized to BNT162b2 (mean of 9.8 months post-Dose 2 at the beginning of the analysis period) was 70.3 cases per 1,000 person-years, compared with an incidence of 51.6 cases per 1,000 person-years among 17,748 study participants originally randomized to placebo and crossed over to BNT162b2 (mean of 4.7 months post-Dose 2 at the beginning of the analysis period). An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period. Only 3 severe COVID-19 cases were reported during the analysis period, all of which occurred among study participants originally randomized to BNT162b2. The reported incidence of COVID-19 among study participants who completed the primary series <4 months="" prior="" to="" the="" start="" of="" the="" analysis="" period="" was="" 43.4="" cases="">per 1,000 personyears. In contrast, during the blinded, placebo-controlled follow-up period of the study with data cutoff of March 13, 2021 (prior to the Delta variant surge), the incidence of COVID-19 among BNT162b2 recipients in the Evaluable Efficacy Population (nearly 60% of whom had 4 months or more of blinded follow-up post-Dose 2) was 12.6 cases per 1,000 person- years. This observation suggests that while waning immunity is one potential factor that may have contributed to the higher incidence breakthrough cases during the Delta variant surge, it is possible that other factors (e.g., dynamics of Delta variant transmission and potential differences in vaccine effectiveness against the Delta variant vs. strains circulating during the placebo-controlled portion of the trial) may also have contributed.
【 在 yyyy78 (yyyy) 的大作中提到: 】 : 'Not Supposed To Happen': US State With Highest Vaxx Rate Sees Record Surge : In COVID Cases : https://www.zerohedge.com/covid-19/not-supposed-happen-us-state-highest- vaxx : -rate-sees-record-surge-covid-cases
likely-to-get-covid-insider-leaks-fda-study/
During that initial placebo period, the document reports that the infection rate of this group was “12.6 cases per 1,000 person-years,” which equates to a 1.3% infection rate. Following their injections, there were “43.4
cases per 1,000 person- years” or a 4.34% infection rate.
“So, when they weren’t injected, their infection rate was 1.3%, and when
they got injected, it was 4.34%. It went up by over 300%,” Kingston
observed. “That 300% increase is a correlation, it’s not an anomaly.”
我只能说这些人不学无术，到处造谣。现在让我们把原始的内容拿出来分析一下，原文在最后面。
辉瑞在最早进行疫苗的clinical trial时设计了两组人来验证疫苗的可靠性和有效性。一组是一开始就打了辉瑞疫苗的，一组是placebo组。但随着2020年12月14日疫苗获得
紧急授权以后，实验开始揭盲，placebo组成员可以接受两针辉瑞疫苗。
这个报告所使用的数据主要是对这些辉瑞疫苗实验人群中没有感染新冠的人员，进行的在delta爆发期间感染情况的分析。因此，分组情况仍然跟原来的一样，1组是从一开始就打了辉瑞疫苗的，participants who completed the 2-dose primary series early in the study，（originally randomized to BNT162b2）；一组是开始是placebo组
，后来crossed over到BNT162b2的，those who completed the 2-dose primary
series later in the study (i.e., those who were originally randomized to
placebo and then crossed over to BNT162b2)。
数据分析的时间段是2021那年7月1日到8月31日，重点考察的是这两个人群在delta疫情期间的表现情况。到7月1日为止，第一组人群平均打完疫苗时间为9.8月，而第二组人
群平均打完疫苗时间为4.7月。
结果1），在delta疫情期间，第一组是70.3 cases per 1,000 person-years，而第二
组是51.6 cases per 1,000 person-years，可见，由于第二组打疫苗时间更迟，其对
delta的保护作用更好。
结果2），也是谣言传出来的地方，让我们先来看看原文怎么写的。
The reported incidence of COVID-19 among study participants who completed
the primary series <4 months="" prior="" to="" the="" start="" of="" the="" analysis="" period="" was="">43.4 cases per 1,000 person years.
对于那些原先在placebo组，但是在7月1号前4个月内打了疫苗的人，他们(在7月1日到8月31日之间)的感染率为43.4 cases per 1,000 person years.括号里面内容是我加的
，要说明清楚这是在分析这些人在delta爆发期间，疫苗的防范效果。
In contrast, during the blinded, placebo-controlled follow-up period of the study with data cutoff of March 13, 2021 (prior to the Delta variant surge), the incidence of COVID-19 among BNT162b2 recipients in the Evaluable
Efficacy Population (nearly 60% of whom had 4 months or more of blinded
follow-up post-Dose 2) was 12.6 cases per 1,000 person-years.
而与此对照的是，在2021年3月13日前，也就是delta疫情尚未爆发前，那些打了辉瑞疫苗的人（BNT162b2 recipients）对新冠病毒的感染率是12.6 cases per 1,000 person-years，其中60%以上是打了疫苗4个月以上的。由于2020年12月只是对placebo组进行
了揭盲，以便他们决定是否需要接受新冠疫苗，从一开始就在疫苗组的人员，仍处于
blinded, placebo-controlled follow-up period。
由此可以看出，43.4指的是，打了疫苗4个月之内的人，对delta的防范能力，12.6指的是，打了疫苗的人，对原始新冠病毒的防范能力，说打了疫苗后反而导致感染新冠的可能性上升了300%，就是张冠李戴，胡说八道。这也是为什么紧接着43.4和12.6这两个数据以后，报告在讨论为什么delta会导致比较高的breakthrough。
This observation suggests that while waning immunity is one potential factor that may have contributed to the higher incidence breakthrough cases during the Delta variant surge, it is possible that other factors (e.g., dynamics of Delta variant transmission and potential differences in vaccine
effectiveness against the Delta variant vs. strains circulating during the
placebo-controlled portion of the trial) may also have contributed.
下面是FDA上的原文链接，以及其中最重要一段文字。
https://www.fda.gov/media/152176/download
6.4.6. COVID-19 cases among C4591001 study participants during the Delta
variant
surge
Responding to an FDA request, Pfizer performed a post hoc analysis of
protocol-specified
COVID-19 cases accrued during the period of July 1, 2021 through August 31, 2021
(corresponding to the Delta variant surge) among participants 16 years of
age and older who
completed the 2-dose primary series. The analysis compared rates of COVID-19 among
participants who completed the 2-dose primary series early in the study (i.e., those who were
originally randomized to BNT162b2) vs. those who completed the 2-dose
primary series later in
the study (i.e., those who were originally randomized to placebo and then
crossed over to
BNT162b2). Study participants included in the analysis were those who
remained at risk for first
occurrence of COVID-19 following the BNT162b2 primary series (i.e.,
participants who
previously reported COVID-19 or who received additional study vaccinations
after the primary
series were excluded). The analysis used data extracted on September 2, 2021 from the study’s
live database; the datasets were not submitted to FDA.
Although not independently verified by FDA, the post hoc analysis appears to indicate that the
incidence of SARS-CoV-2 during the analysis period among 18,727 study
participants originally
randomized to BNT162b2 (mean of 9.8 months post-Dose 2 at the beginning of
the analysis
period) was 70.3 cases per 1,000 person-years, compared with an incidence of 51.6 cases per
1,000 person-years among 17,748 study participants originally randomized to placebo and
crossed over to BNT162b2 (mean of 4.7 months post-Dose 2 at the beginning of the analysis
period). An additional analysis appears to indicate that incidence of COVID-19 generally
increased in each group of study participants with increasing time post-Dose 2 at the start of the
analysis period. Only 3 severe COVID-19 cases were reported during the
analysis period, all of
which occurred among study participants originally randomized to BNT162b2.
The reported incidence of COVID-19 among study participants who completed
the primary
series <4 months="" prior="" to="" the="" start="" of="" the="" analysis="" period="" was="" 43.4="" cases="">per 1,000 personyears. In contrast, during the blinded, placebo-controlled
follow-up period of the study with data
cutoff of March 13, 2021 (prior to the Delta variant surge), the incidence
of COVID-19 among
BNT162b2 recipients in the Evaluable Efficacy Population (nearly 60% of whom had 4 months
or more of blinded follow-up post-Dose 2) was 12.6 cases per 1,000 person-
years.
This
observation suggests that while waning immunity is one potential factor that may have
contributed to the higher incidence breakthrough cases during the Delta
variant surge, it is
possible that other factors (e.g., dynamics of Delta variant transmission
and potential
differences in vaccine effectiveness against the Delta variant vs. strains
circulating during the
placebo-controlled portion of the trial) may also have contributed.
'Not Supposed To Happen': US State With Highest Vaxx Rate Sees Record Surge In COVID Cases
https://www.zerohedge.com/covid-19/not-supposed-happen-us-state-highest-vaxx-rate-sees-record-surge-covid-cases
11%没打完疫苗的，贡献了60%的新冠病人，还好意思来说是疫苗的错，真是脑子坏掉了。
【 在 yyyy78 (yyyy) 的大作中提到: 】
: 'Not Supposed To Happen': US State With Highest Vaxx Rate Sees Record
Surge
: In COVID Cases
: https://www.zerohedge.com/covid-19/not-supposed-happen-us-state-highest-
vaxx
: -rate-sees-record-surge-covid-cases