Safety and efficacy have always NOT been, in the COVID-19 shot context

Revisiting the 162nd FDA Advisory Committee reviews Pfizer's Covid-19 vaccine — 12/10/2020 where we discuss Pfizer's clinical trial data wrt Bell's Palsy

I was inspired by a fantastic investigation written and published by Dr Ah Kahn Syed this morning that summarizes some of the findings in the 2 million pages of Pfizer data (forced by FOIA to the public eyes by Aaron Siri - thank you!). You can read that here. And here:

The Pfizer Job

Many irrefutable observations made from Pfizer’s own efficacy data and the FDA’s wildly lame (and impossible) review of it are revealed in this article, including how the whole 95% efficacy thing was a sham. By the way, that 95% efficacy claim was based on relative risk reduction (RRR) not absolute risk reduction (ARR).¹² I explain the difference here.

But I would like to focus on the 162nd FDA Advisory Committee reviews Pfizer’s COVID-19 vaccine that took place on December 10th, 2020, also heavily referenced in Dr. Syed’s amazing article.

Please watch this video and archive it. The YouTube video I shared below starts the viewer at Susan Wollersheim’s presentation of the FDA’s assessment of the Pfizer phase 2/3 clinical trial data in terms of safety and efficacy as of November 14, 2020. She was selected as one of two of the clinical reviewers of the original application for the BLA (Biologics License Application) for the Pfizer/BioNTech Comirnaughty product. She’s a pediatric MD out of Georgetown University, and she is listed on the presentation as being affiliated with CBER (Center for Biologics Evaluation and Research), I imagine via her role as a clinical reviewer. But to be honest, I am not sure why she would have been selected to be a clinical reviewer or the presenter of this data as she did not do the analysis.

Question: Who did do the analysis? Because they should be fired, in my opinion.

I would like to focus on the part of this presentation where Susan speaks on pharmacovigilance. It starts at 6:09:30.

As we all know, pharmacovigilance is of utmost importance, especially when dealing with experimental biological products under EUA with no long-term data attached to them. After all, it’s all about prevention of emergent unsolicited adverse events (AEs) when it comes to pharmaceutical products!

Here’s the schematic that Susan used in her presentation to make sure that everyone felt awesome about the fact that post-injection AEs were going to be closely monitored by FDA and CDC via rigorous reporting of AEs to a variety of pharmacovigilance databases. Look at all of those pointy blue arrows and those gorgeous primary colors! Kudos on that!

Well, I’m convinced. AEs will be reported - and investigated - if a signal is detected by FDA or CDC using one of these systems. Phew. Glad that’s nothing we had to worry about.

Here’s a quote from her presentation found at 6:12:30:

Both FDA and CDC will take a collaborative and complementary approach on reviewing in AEs. FDA will individually review all serious adverse events on a daily basis, and FDA will also examine other sources for adverse events, produce the literature and perform data mining to determine if adverse events are disproportionately reporting for the candidate vaccine compared to all other vaccines in VAERS.

Any potential safety signal identified will be investigated [irrespective of attribution to the vaccination].

Sounds great, right? How could they possibly ever miss safety signals from VAERS if both the FDA and the CDC would be fine-tooth combing the data and investigating any potential safety signal?

Never forget: Remember NIAID Director Dr. Anthony Fauci and CDC Director Dr. Rochelle Walensky testified before the Senate on July 20, 2021 to provide updates on the COVID-19 response? They said:

Our work did not end with authorization of these vaccines though, we have to share as much information as we can with the public to help with trust and transparency. We’re also deeply involved with CDC on safety surveillance for the vaccines, as they go into millions of healthy people, to understand what adverse events might be related. And we continue to find that the known and potential benefits of these vaccines far outweigh the known risks, even as additional rare risks have been discovered.³

Additional “rare risks”, eh? Which ones? Death, perhaps?

To answer my own question as to how they could possibly ever “miss” safety signals and/or not investigate them, I can think of at least two ways this might happen: 1. If they do not look for them, or 2. If they find them and keep it a secret/hide it from the public.

If Pfizer, Moderna, FDA, CDC, CBER, Health Canada, TGA, or other entities identified safety signals or rare risks associated with COVID-19 “vaccines”, concealed them from the public, and promoted the vaccines as safe - sometimes under government mandates - to drive sales for [personal] profit, such actions could constitute legal fraud.

Black’s Law Dictionary defines it in the following way:

All multifarious means which human ingenuity can devise, and which are resorted to by one individual to get an advantage over another by false suggestions or suppression of the truth. It includes all surprises, tricks, cunning or dissembling, and any unfair way which another is cheated.⁴

Intentional deception by a pharmaceutical company (or its subsidiaries) to mislead regulators, healthcare providers, insurers, or consumers for financial gain, often violating laws like the False Claims Act (FCA) or Food, Drug, and Cosmetic Act (FDCA) constitutes fraud.⁵

It sounds to me like everyone in the legal realm would agree that if a pharmaceutical company and/or revolving-door backer (FDA - the EUA authorizer) makes money off of an unsafe product that they persistently - as in, throughout administration of shots and collection of AE data that clearly indicated unsolicited emergent SAEs - promoted as safe, then that’s fraud.

Alrighty then, back to the 162nd presentation. Let’s rewind to the part where Susan presents some of the AE data as part of the Safety Data section of her presentation. There is a slide at 6:02:09 that summarizes the higher frequency AEs in “vaccine” group vs. placebo. It is odd that they wrote ‘non-serious’ in brackets beside AEs (ie: Unsolicited AEs (non-serious)), because one of the listed AEs is Bell’s Palsy (BP). I am not sure that the people who succumbed to this condition following injection with these experimental shots would consider this a non-serious outcome. I am not sure that anyone who has suffered from BP would consider their experience non-serious. It’s quite crippling, in fact, and involves a dysfunction of facial cranial nerve VII. Some believe that it is the result concurrent of viral infections, but the actual cause is not known.⁶ It can lead to irreversible damage to your facial nerve, irregular regrowth of nerve fibers, or partial or complete blindness of the eye that won’t close. That doesn’t sound non-serious to me.

Many people - like the wonderful and brave Canadian Carrie Sakamoto (COVID-19 shot injured since 2021) - have succumbed to Bell’s Palsy following their COVID-19 shots.

Following a thorough medical evaluation, Ms. Sakamoto was diagnosed with severe and permanent Bell’s Palsy attributed to the Pfizer vaccine.⁷

Carrie is now leading a class action lawsuit to get some kind of restitution.

…the lawsuit goes on to allege misfeasance in public office by health officials in various governmental agencies [including Health Canada and the Canadian Broadcasting Corporation].

GOD speed Carrie (and Eva Chipiuk and James Kitchen). You’re beautiful, by the way, inside and out.

So, Bell’s Palsy. You know what it is. Justin Bieber knows what it is. You know who Justin Bieber is.

I’ve written articles on this particular AE before, not for nothin’. The following one posted below is a write-up of a presentation I’ve given in the past (as in, 2022) where I used the Bradford Hill criteria to prove causation. I used BP as an example to demonstrate coherence because the signal for BP was found in both Moderna and Pfizer’s own clinical data, and it was also loud and clear in VAERS, even in early 2022. Even in early 2021! (See below.)

I wrote a couple more articles on this subject matter here and here.

Below is a screenshot from Susan’s presentation with data pertaining to a BP signal emanating from the Pfizer clinical trial (Study C4591001) data in the context of unsolicited AEs. An unsolicited AE is one that wasn’t expected to show up in the context of a ‘drug’. It’s like that annoying frat boy who shows up at your party who wants to throw ping pong balls into a cup so he can have an excuse to jump naked into a pool in an attempt to get a girl. Pro-tip: we’d rather you didn’t do that.

Read the last bullet point.

• Bell’s Palsy

  - Vaccine n = 4, placebo n=0

Of the 18,801 “vaccine” participants in the C4591001 phase 2/3 study analysis populations, there were 4 cases of BP reported. There were 0 cases reported in the placebo recipients of which there were an equivalent 18,785 total participants. That means that at the time of this presentation, those data had been compiled by someone, presented by Susan, and demonstrated a clear signal for BP in the “vaccine” group.

A simple odds ratio and relative risk calculation for BP yields 8.99 (95% CI: 1.08–74.78, p=0.04) for the “vaccine” group (4/18,801) compared to the placebo group (0/18,785), indicating a significantly increased risk associated with the vaccine.

But as opposed to the “Plausible relation to vaccination” notice in the case of Lymphadenopathy, according to this presentation, there is nothing to be concerned about with BP because the “Observed frequency [is] consistent with background rate in general population”. What background rate? In what context? Huh? What kind of sub-in statement for ‘Caused by the “vaccine”’ is that?

The background rates for occurrence of BP would be the same for everyone because they came from the same sample population. The “don’t be concerned” statement is irrelevant in the context of a clinical trial where the comparison groups share the same baseline characteristics, including the background incidence rate of Bell’s palsy (BP). Am I missing something here?

N.B. This is THEIR preliminary data, as in, from November 14, 2020. 2020!!

If those n-values for BP hadn’t been beside a dashed point, under a bullet point, under an afterthought, on a slide tucked into a rapid-fire presentation by a person who didn’t analyze the data, with the words ‘non-serious’ written in the title of the slide, than a whole whack of people might have raised more than an eyebrow, in my humble opinion.

Also on this slide underneath our n-values is the claim that there is “No clear basis upon which to conclude a causal relationship at this time”.

Well, Susan, CBER, VRBPAC and FDA, I would disagree. Even at that time, there was a clear signal with an established odds ratio that demonstrated more than a precautionary-principle-ish significant 9 times greater risk of BP development in “vaccine” context.

And as for causation, the Bradford Hill criterion coherence is a great pick because according to both the Pfizer and the Moderna clinical trial data, there was a signal for BP (aka: Facial paralysis) in the “vaccine” groups that were not seen in the placebo groups.

Coherence in the Bradford Hill criteria refers to the compatibility of an observed association with existing knowledge (that would include data from clinical trials), theories, and established facts about the natural history and biology of a disease.

Here is a screenshot from an article I wrote summarizing some of Moderna’s clinical trial AE observations.

https://jessicar.substack.com/p/i-dont-know-what-to-say?utm_source=publication-search

For additional coherence, what other data did we have to go on just a little while into the injection campaign? What was that Susan said about pharmacovigilance? Something about FDA data mining to determine if AEs are disproportionately reported for the candidate “vaccine” compared to all other vaccines in VAERS? I haven’t seen these hardcore stealth data mining jobs by FDA or CDC peeps, but I have done some myself. I also went one step further from looking at ‘all other vaccines in VAERS’, I went back in time to 1990.

Here’s an example.

This chart shows the absolute count of Bell’s Palsy reports submitted to VAERS from 1990-2025, where I only queried the nucleoside modified RNA COVID-19 shots (Pfizer/Moderna) for 2021 onward. From 1990-2020, the query covers all vaccines combined.

Isn’t that interesting. Look at the increased number of reports in 2021 onward. One might even call that an anomalous surge in reporting. Was this surge not reviewed by the FDA/CDC? Was it ignored because BP is considered to be a non-serious AE? By the way, the fact that I only queried the nucleoside modified RNA COVID-19 shots (Pfizer/Moderna) for 2021 onward makes the BP reporting surge even more striking.

So what do you think CDC/FDA? Do we satisfy coherence?

The reason I felt so strongly about writing this up with a specific focus on BP is because it was so obvious as a safety signal in the clinical trial data for both Pfizer and Moderna. This was before it was EUAed/mandated into the general public. This was before the tragedy that has become the unspeakable scandal that has decimated lives, ruined small businesses and shattered faith in health agencies and government ensued.

IT WAS KNOWN. By Pfizer. By Moderna. By the FDA. By the CDC. By CBER. By VRBPAC. By the EMA. By HC. By the TGA:

BY EVERYONE involved. You can’t plead ignorance. Because it’s your data. The clinical and pharmacovigilance data are yours. To monitor. To investigate. To use to withdraw unsafe products when warranted.

QUESTION: Why were these signals dismissed at the time, and what were these so-called FDA/CDC vigilant data miners actually doing if not the required safety signal monitoring and emergent danger signal assessments (unsolicited!), to include Bradford Hill analyses and PRR assessments?

WHAT WERE THEY DOING?

To me, this is a clear case of fraud and misconduct. The BP signal was apparent in November 2020, and provably demonstrated risk during the clinical trials when comparing the drug and placebo arms. That’s what the clinical trials are for: to assess risk prior to market approval and administration. Even if one wished to argue (or screaming and crying on the floor) “emergency”, I would argue back that the risk AT LEAST must be acknowledged and informed consent provided.

People might have said: “I’ll take the risk and thank you for letting me know and giving me the right to choose”. But we weren’t given this chance or choice. That’s the part that rots me the most about all this. We were, and are, treated like brain-deficient cattle. A group of useless-eaters too unintelligent to make sovereign decisions on our own.

Well you know what, I disagree with that too, policy-makers. In fact, I think that we, as a group of independent thinkers and scientists, have done an exceptional job analyzing your data.

You’re welcome.

1. Marabotti C. Efficacy and effectiveness of covid-19 vaccine - absolute vs. relative risk reduction. Expert Rev Vaccines. 2022 Jul;21(7):873-875. doi: 10.1080/14760584.2022.2067531. Epub 2022 Apr 19. PMID: 35426755; PMCID: PMC9115787

2. Brown RB. Relative risk reduction: Misinformative measure in clinical trials and COVID-19 vaccine efficacy. Dialogues Health. 2022;1:100074. doi:10.1016/j.dial.2022.100074

3. https://www.rev.com/transcripts/fauci-walensky-covid-19-response-testimony-senate-hearing-transcript-july-20

4. Black’s Law Dictionary, 5th ed., by Henry Campbell Black, West Publishing Co., St. Paul, Minnesota, 1979

5. U.S. Department of Justice. Pfizer to Pay $2.3 Billion for Fraudulent Marketing. Press Release. September 2, 2009. Available at: https://www.justice.gov/opa/pr/pfizer-pay-23-billion-fraudulent-marketing. Accessed October 8, 2025

6. https://en.wikipedia.org/wiki/Bell’s_palsy

7. https://www.rebelnews.com/alberta_woman_files_10_5_mil_lawsuit_against_government_cbc_vaccine_misinformation