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Pfizer Pregnancy Trial Showed the COVID Shots Increased AESIs (Like Major Congenital Abnormalities) in Newborns by Over 4X

Pfizer Pregnancy Trial Showed the COVID Shots Increased AESIs (Like Major Congenital Abnormalities) in Newborns by Over 4X

By STEVE KIRSCH

There was no benefit in terms of reduced COVID infections. But vaccinated moms had major adverse events happen to their babies at a rate 4.2X higher than unvaxxed moms. Does anyone care?

This is the conclusion of Dr. Thorp’s most recent paper (“Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the U.S. Government,Medical Organizations, and Pharmaceutical Industry Claim?”) which was accepted for publication in a peer reviewed journal and will be available soon.

Executive summary

Pfizer recently updated the results of their randomized clinical trial of the COVID shots on pregnant women entitled “To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older. ClinicalTrials.gov ID NCT04754594.

This prompted me to have a second look at these results which were first posted on July 14, 2023, over a year ago.

Did you know that the study showed that if you were assigned the vaccine, your child had a stunning 4.2X higher rate of AESIs such as MAJOR congenital abnormalities and developmental delays in just the first 6 months after birth?

Because the trial enrolled fewer women than planned, the effect size reached only the 90% level of significance. Based on just this trial, we are 90% certain that the vaccines made things worse. However, when you look at other data, the certainty approaches 100%.

4.2X is jaw dropping for an effect size for these types of major birth defect adverse events.

Was there a benefit? Nope. Moms in both groups got the same number of COVID infections (2 in each group). Vaccine efficacy estimated at a measly 3.8 (because the groups were different sizes). A perfect vaccine is 100. A vaccine which does nothing is 0. The 3.8 value was both tiny and NOT statistically significant. It’s entirely possible that the vaccine increased your risk of getting COVID. We can’t tell from the study.

This was all known more than 5 months ago when the results were first posted.

Why didn’t the CDC warn women that they were wrong?

This double-blinded placebo controlled trial which is considered to be the best evidence in medicine shows that it’s 90% likely it made things worse.

It’s Pfizer’s own data published on Clinical Trials.gov using gold-standard DB-RCT methodology. Anyone can analyze it. It’s in plain sight. Doesn’t get any better than this.

Today, more than 5 months after the lack of any COVID benefit was published on the NIH website (clinicaltrials.gov), the CDC is still silent on this.

Is the entire medical community blind, ignorant, or just corrupt? NOT A SINGLE MAINSTREAM doctor is speaking out. NOT ONE.

Dr. James Thorp got fired for speaking out about the vaccine harms to pregnant women so he’s not mainstream anymore since he’s out of the system. One of the few honest doctors and he gets fired. What does that tell you? His research which has been published in peer-reviewed journals, confirms the results of the Pfizer trial. In spades.

We have a very corrupt medical system where everyone is afraid to tell the truth.

About the Pfizer study on women getting the COVID shots during pregnancy

ClinicalTrials URL: NCT04754594

Start date: Feb 16, 2021
Announced date: February 18, 2021.
Planned enrollment: 4000
Actual enrollment: 683
First results posted: July 14, 2023
Results including COVID rates posted: June 24, 2024

Participants in the study were enrolled between 24 and 34 weeks of gestation, as part of the inclusion criteria. The trial specifically required healthy women with uncomplicated, singleton pregnancies within this range. 348 maternal participants were enrolled and randomized to receive either the vaccine or placebo. Blinded follow-up: From Day 1 to one month post-delivery. Unblinded follow-up: Extended up to 6 months post-delivery for participants initially vaccinated with BNT162b2.

Why they didn’t do the same for the people who got the placebo is a mystery to me. The reason usually given is that it’s unethical to withhold the COVID vaccine from those that got the placebo.

The study showed it’s 90% certain that the shots increased the rate of special interest adverse events like MAJOR congenital abnormalities and developmental delays in the first 6 months of life, most likely by a factor of 4.2X.

Read the description of AESI which I highlighted in purple for you:

There were 8 AESI’s in the treatment group and only 2 in the larger placebo group.

Let’s do our own statistical analysis on these numbers using a Fisher exact test.

What this means is:

  1. We are 90% certain that women who got the shots had higher AESIs than those getting the placebo
  2. The most likely estimate of the magnitude of the effect is that it was 4.2X more likely in pregnant women who got Pfizer COVID shot

What mother wants that? MAJOR congenital abnormalities and developmental delays??!!

Was there a benefit? Nope.

The trial also showed that the COVID vaccine did NOT work; both groups got EXACTLY the same number of COVID infections!

Here you go, right from the document:

In short, the number of cases (which they don’t actually disclose, just the person years in each group) was statistically identical in both arms.

Don’t take my word for it though. It’s right in their statistical analysis:

The VE estimated value was 3.8. Their VE is based on 100. So a perfect vaccine is 100. A vaccine which doesn’t do shit is 0. Their best estimate is 3.8 and the confidence intervals are so huge that it means that there was NO detectable efficacy. They could have had 100X more people and still it’s likely they wouldn’t have been able to find a signal.

There were other COVID infection incidence outcomes (see Outcomes 10 and 11) included in the results and those also were not statistically significant (2-Sided 95% CIs were -466.5 to 94.6 and -104.9 to 86.5, respectively).

It took over 3 years to tell us that there was no COVID infection rate difference!

The trial was announced on February 18, 2021.

The results were first published on clinicaltrials.gov on July 14, 2023, nearly 2.5 years later (see version 21), but many parts were not reported at the time. But the birth defects were reported (section 19) at that time. So we’ve known about the AESIs for 16 months now.

Section 9 (COVID incidence) was first reported in version 24 which was published on June 24, 2024 which was nearly one year later. So we’ve known it didn’t work for the last 5 months.

Notably, since the results were first published, it took almost a full year to count up the 2 COVID cases in each of the two groups (a total of 4 COVID cases) before they were reported. Why did that take so long?

This is truly the “speed of science” that they were able to do this in just over 3 years! Remarkable.

Bottom line: no difference in risk of COVID.

The Pfizer press release

They simply forgot to issue one!

So the mainstream media will not cover it.

They expect everyone to monitor clinicaltrials.gov and then read through gobs of pages to figure out what happened.

Fortunately, I don’t have a problem with reading through the data, because sometimes you stumble on stuff that they don’t want you to see.

Papers by Dr. James Thorp showing similar harms to vaccinated women

One doctor is speaking out. So they fired him.

COVID-19 Vaccines: The Impact on Pregnancy Outcomes and Menstrual Function
”When normalized by time-available, doses-given, or number of persons vaccinated, all COVID-19 vaccine AEs far exceed the safety signal on all recognized thresholds. These results necessitate a worldwide moratorium on the use of COVID-19 vaccines in pregnancy.”

Are COVID-19 Vaccines in Pregnancy as Safe and Effective as the U.S. Government, Medical Organizations, and Pharmaceutical Industry Claim? Part I
“Compared to influenza and all other vaccine products, COVID-19 vaccines in pregnancy have demonstrated unacceptable breaches in safety signals across all 37 AEs investigated, 27 antepartum and 10 postpartum/newborn. All 37 AEs breach CDC/FDA limits for safety and are consistent with the authors’ extensive clinical observations. Summary statistics for the deviation of safety signal breaches are described here: mean (n, range) of the PRR was 69.3 (46, 5.37 – 499), z statistic 9.64 (46, 3.29 – 27.0), and Chi-square was 74.7 (26, 28.9 – 148). The magnitude of these safety deviations is unparalleled given the CDC/FDA guidelines defining a PRR ≥ 2 or a Chi-square ≥ 4 as a cause for alarm. The z statistic is informative as it describes the standard deviation of AEs in the COVID-19 vaccines above other vaccines. Most p-values were in the range of one in a million or less.”

The final version of this paper was accepted for publication in a peer-reviewed journal and will be out soon. The new conclusion is at the start of this article. It is stunning to have this published in a peer-reviewed journal.

Increased risk of fetal loss after COVID-19 vaccination
“When normalized by time-available, doses-given, or number of persons vaccinated, all COVID-19 vaccine AEs far exceed the safety signal on all recognized thresholds. Specifically for miscarriage we found the global relative risk was 177 (95% CI 114.4–283.5) compared to influenza vaccination.”

Summary

The vaccine is a total shit show for pregnant women.

We now know that Pfizer’s own study shows no infection benefit, but a stunning 4.2X higher rate of AESIs such as major congenital abnormalities and developmental delays in just the first 6 months after birth. From Pfizer’s study alone, we are 90% certain the vaccine is harmful. Dr. Thorp’s work cited above reduces the chance of error to close to zero. In his study, all p values were ≤ 0.001 with the majority being <0.000001.

With no benefit and clear harms, the medical community should immediately stop recommending these shots for pregnant women.

Since these results have been known for 5 months and the medical community is still pushing the shots on pregnant women, I believe I can confidently predict that we should expect no changes will happen.

What will Trump’s proposed Surgeon General say? Will anyone dare ask?

 

Original source: https://kirschsubstack.com/p/pfizer-pregnancy-trial-showed-the

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