Pfizer post PARTIAL results of their "COVID vaccine in pregnancy" trial

They were only able to enroll 349 patients into the trial so all the adverse event signals were NOT statistically significant. So now they can claim that there were no safety signals!

Note

I originally wrote this article when the Pfizer trial results were first announced in July 2023. It has been sitting in my drafts because I wanted to make it perfect. I’m publishing it now because it is relevant to the article I just published on my survey results. The tl;dr of this article is that they are still withholding data and not being transparent. If it was safe, there would be a paper on this. There is no paper.

You don’t need to be a rocket scientist to figure out what that means.

Executive summary

Pfizer quietly posted the results of their pregnancy trial and didn’t tell anyone.

I found out about it by accident.

The trial results are here.

Since they enrolled only 349 women, none of the safety signals were statistically significant.

There were a number of things in the filing that should cause a great deal of concern:

1. some outcomes. 3 of 8 primary and 6 of 8 of secondary lacked data Why? July 2024 mentioned

2. 2x of defects

3. 3x of xxxx thorp AE

4. No detail given in the effects (e.g., sec 6). Lumped into 1

5. Inconsistencies confuses critical thinkers like me (billiruben from thorp)

6. Never mentioned birth defects, pregnancy losses, miscarriages, spontaneous abortions omitted neonatal deaths

7. the word miscarriage, abortion never mentioned. How is that possible?

8. This was all done quietly with no press release.

I will detail all of these defects in this article.

It appears I was the first journalist to notice these results were posted and point out these problems.

Introduction

Like the rest of the world, I have been anxiously awaiting the results of the Pfizer clinical trial NCT04754594 officially entitled “A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER.”

The trial, which began in Feb 2021, originally intended to enroll 4,000 women, but enrollment stopped in late 2021 with just 349 participants.

Why? They claimed it was because all women wanted to get the vaccine so they were unable to recruit any more subjects. Details in this excellent Substack article: EXCLUSIVE: Whatever happened to Pfizer's covid vaccine trial in pregnant women?

So they changed the description in clinicaltrials.gov to match what they had enrolled: “in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation.”

The official trial completion date was July 15, 2022. By law, they have 1 year from that data to post their results on clinicaltrials.gov.

And in compliance with the law, they filed the outcomes on the very last day possible to still be in compliance with the law: July 14, 2023. See proof here.

The government reviewed their filing, found it deficient, and published it with their commentary on August 4, 2023 that they didn’t comply with the law and withheld information. The government then updated this on August 7, 2023 according to the record

What they posted

You can read it here.

There was a lot of detail for things that nobody cares about like injection site issues:

For injection site reactions, they DID publish the comparison!

But when it came to the really “interesting” data (Primary Outcome #6), they provided no detail whatsoever!!! Just the overall event rates in the two groups. They did NOT list which events happened. This is nuts. This is a HUGE RED FLAG. But nobody is questioning this except me. You always list the serious AEs by type and number. For example, if there were 10 cardiac arrests in the treatment group, and 1 event of 6 different types in the placebo group, that would be huge. But they provided no detail!

Many outcomes lacked data entirely

How could Pfizer possibly not know what the outcomes were by now in ever? This is impossible that they don’t know.

The most likely reason: the results are really bad so they are keeping the results secret forever.

Statistically significant

Outcome #19:

4X more likely to get an SAE in the child

No detail!

What this means

This whole report is extremely suspicious.

I only found out about it because a “fact checker” (John Gregory, the health editor at newsguardtech.com) is writing a hit piece on my Substack to discredit me, so I decided to check if the trial results were published yet in formulating a response to one of his questions designed to discredit me. So it was a stroke of dumb luck that I stumbled upon the publication of these results.

More importantly, how is there zero coverage in the mainstream media anywhere in the entire world on this?

Don’t people want to know whether the drug is safe in pregnancy or not?

The CDC has been claiming it was safe, but they had no evidence for those claims because the study had never even started when they made those claims.

Apparently, Congress doesn’t care about this either. I seriously doubt any representative from Pfizer will be called to answer questions like, “Why were no results published?”

And of course, nobody in the mainstream media wants to know the answer to this either. Nor will anyone ask the FDA, “How will you sanction Pfizer for not complying with the federal regulation?”

About the federal regulation

The requirement to post clinical trial results on ClinicalTrials.gov within one year of trial completion is not a federal law itself, but it is mandated by federal regulations. The requirement comes from the Final Rule of the U.S. Food and Drug Administration Amendments Act (FDAAA) of 2007. It stipulates that certain clinical trials must submit summary results, including outcomes and adverse events, to the ClinicalTrials.gov database within one year of the trial's completion date. This rule aims to improve transparency and public access to clinical trial data.

There can be consequences if you don't follow the federal regulation and fail to post clinical trial results on ClinicalTrials.gov as required. The U.S. Food and Drug Administration (FDA) can take enforcement actions against sponsors of applicable clinical trials who do not comply with the reporting requirements. This can include warning letters, fines, and other regulatory actions. Non-compliance with these regulations can also impact the reputation of the sponsor and their ability to conduct future clinical trials. It's important to adhere to these regulations to ensure transparency, accountability, and the integrity of clinical research.

But… since it is Pfizer, the FDA won’t do anything. Clearly, Pfizer is allowed to violate the regulations without being punished or reprimanded at all; that’s just the way science works.

Also, their vaccine can kill as many people as they want including unborn babies, and there will NEVER be any criminal liability for any of this.

That’s just the way it goes.

For more information

Please see my tweet which I published at 2:30am this morning and it already has nearly 500K views:

See also my other post where I questioned why the mainstream media isn’t demanding answers from Pfizer or the FDA. They are basically silent and do not care at all how many pregnancies were affected by these vaccines:

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Summary

There is no reason for Pfizer withholding the key outcomes of this important study. The only reason they would do this is if the study results were bad.

By not filing their outcomes as required by law, Pfizer is basically saying, “We can violate federal regulations with impunity. We will not be held accountable.”

And they are right. Nobody is holding them accountable. The mainstream media, mainstream medical community, and lawmakers in Congress are all giving them a pass to do whatever they want.

People are being harmed.

But none of these people will hold the drug companies accountable. They are not committed to exposing the truth. They are, in fact, committed to suppressing the truth.

History will not look kindly on any of these people.