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A Pivotal Meeting
On October 22, 2020, a meeting took place at the FDA. With whom did high FDA officials meet? With the members of their VRBPAC committee. The awful acronym stands for ‘Vaccines and Related Biological Products Advisory Committee.’
What is the role of this committee? It’s easy to explain the role of the VRBPAC committee now that most Americans have heard about ACIP.
ACIP (Advisory Committee on Immunization Practices) belongs to the CDC and votes on to whom the CDC recommends vaccines.
VRBPAC belongs to the FDA and votes on whether a vaccine should be approved or not.
These ‘votes’ are not legally binding; they don’t obligate the CDC and FDA in any way. They are purely ‘advisory.’ But the FDA, almost always, does exactly what its advisory committee advises.
Why even bother then to have these committees? Oh, they are important. Very important in fac. They are needed to build consensus, create legitimacy and secure stakeholder buy-in for the agencies’ decisions.
This legitimizing spectacle isn’t staged for average Americans (because, at least in the past, no normal American even knew about the existence of these committees). No, it’s staged for the army of vaccine enforcers: hospital administrators, doctors, nurses. They must know the line, tow the line and then get, ideally, the entire population aligned.
The October 2020 VRBPAC meeting had disastrous consequences. Not because it went wrong but because everything went according to plan. There was no chance that it would not have gone to plan. It was a very carefully staged, polite spectacle of the cruelest kind.
Preparing Stakeholders for the Covid Shot Emergency Use Authorization
The VRBPAC meeting that day was a purely informational meeting. No voting took place.
It was a long meeting: it lasted pretty much the entire day. It was a virtual meeting, of course, since it happened during the pseudo-pandemic.
The purpose of the meeting was to prepare the ground for the coming Emergency Use Authorization of the mRNA shots. The top officials at the FDA most likely had known for a while that the shots would be EUA authorized but telling the rest of the world had to be managed carefully.
The problem was that the true meaning of an EUA had to be concealed from every member of the VRBPAC committee. Sure, these guys were reliable allies for the FDA and some of them, like Paul Offit, had worked for one or the other federal health agency in the past. But still, could all of them be completely trusted if they knew what an EUA really meant? Maybe, maybe not.
Who Attended the Meeting?
As you can see below, the majority of the attendees came from the FDA and other federal health agencies. They are not members of the VRBPAC.
Unsurprisingly, it’s these officials from the federal health agencies that set the agenda, set the goals and then stage the meetings to make sure that their narrative prevails and that the VRBPAC members vote in the “correct” way.
The pages below are from the meeting’s transcript showing the attendees.
I added the color codes to show who is who: attendees from HHS agencies are orange; members of the VRBPAC are yellow. Most members are medical doctors from universities and hospitals and many of them are pediatricians specializing in infectious diseases.
There was one attendee from the pharmaceutical industry: Paula Annunziato from Merck. She was the industry representative at the meeting. Industry representatives are not voting VRBPAC members.
High FDA, CDC, NIH, NIAID, BARDA Officials Must Be Held Accountable
The meeting on October 22, 2020 is highly incriminatory. If any of these high FDA, CDC, NIH, NIAID and BARDA officials who gave presentations that day are ever being held accountable, there is a wealth of incriminating data in their many presentations.
Did they know they were telling lies? It’s likely. Certainly, the FDA’s legal counsels who approved the presentations must have known that they were riddled with lies, obfuscations and misleading statements. They must be held accountable as well.
In our VRBPAC series, Sasha and I are going over the individual presentations given that day in detail to show the falsehoods, omissions, and conflations - and point out some occasional truths. Presenters, all high officials from various HHS agencies, made it impossible for VRBPAC committee members to get a clear idea of what an EUA actually meant.
Ten health agency employees gave slide show presentations during the meeting. Many of them were long and dense. Since it was a public meeting, all the meeting material is public as well, You can access everything here:
Anyone could have signed up and attended the virtual meeting. But very few who weren’t part of the cabal knew.
Dr. Marion Gruber: Director of Vaccine Research & Review
The FDA’s Director of Vaccine Research and Review, Dr. Marion Gruber, gave the first presentation.
Marion Gruber grew up in Germany and studied biology at the University of Ulm. Then she got her PhD in microbiology and immunology in Kiel, Northern Germany. Afterwards she came to America for a three year post-doctoral fellowship in immunology at the Oklahoma Medical Research Foundation. In 1992, she was employed by the FDA’s Center for Biologics Evaluation & Research. Over the following two decades she rose through the ranks until she reached the high position of Director of Vaccines Research & Review in 2011.
About a year after the VRBPAC’s October 2020 meeting, Gruber left the FDA and became Vice President of Public Health and Regulatory Affairs at a non-profit called IAVI.
Gruber reported to Peter Marks, the Director of the Center for Biologics Evaluation and Research. Marks, by the way, was present at the October 2020 meeting.
In 2021, before she left the FDA, she received an award that, remarkably, she lists to this day (May 22, 2026) in the About section of her LinkedIn profile:
“FDA Innovator Award in 2021, for an unswerving commitment to facilitating development and ensuring the quality, safety and effectiveness of COVID-19 vaccines deploying during the pandemic under Emergency Use Authorization.”
Ensuring the quality, safety and effectiveness of Covid-19 “vaccines” deployed (!) during the pandemic under EUA? What a cruel joke.
As already mentioned, since January 2022 Gruber has been working for a non-profit called IAVI. It was founded in 1996 and its website says “IAVI is a global nonprofit biomedical research organization that develops vaccines and antibodies for HIV, tuberculosis, and emerging infectious diseases.”
Have a look at some of their funders. No wonder IAVI was interested in getting someone like Marion Gruber on board of their non-profit:
Gruber Spoke First
As FDA’s Director of Vaccine Research and Review, Gruber gave the first presentation.
What she said about the Emergency Use Authorization was confusing and misleading. Her words contained falsehoods and impossible promises. Much of what she should have said about the Emergency Use Authorization’s legal framework remained unsaid.
Voting members of the VRBPAC committee who did not have a prior understanding of what an Emergency Use Authorization meant in regulatory terms would have formed a very wrong conception of it by listening to this high FDA official. They would have been assured that EUAs for Covid shots were not something to worry about: The shots would be safe and effective, no doubt.
Apart from the EUA, Gruber told the committee two disturbing truths about the soon to be approved “vaccines.” She pointed out that it wasn’t clear whether the shots were effective, whether they would prevent infection with Covid-19. And she also alerted the VRBPAC to the danger that the “vaccines” could cause Covid-19 and a particularly severe form of it (“enhanced disease”). See the last section of my post.
The Big Lie about EUA Products
During her presentation, Gruber consistently (and often) refers to the EUA authorized vaccines as ‘investigational products.’ See for example on the slide below where she even bolded the word investigational.
US law makes it very clear that EUA products are not regarded as investigational products. And that’s a huge deal in its ramifications. See 21 U.S.C. § 360bbb-3(k). It says:
You can read the full text of the Emergency Use Authorization (21 U.S.C. § 360bbb-3, Section 564 of the FDCA) here: https://www.law.cornell.edu/uscode/text/21/360bbb-3
If EUA products are not considered clinical investigations, then they are not investigational products.
The logical next question is: What are they if not investigational products? Well, if they are not investigational, then it stands to reason that they are experimental products. Which means it’s not clear if they work and if they are safe because nobody investigated the products.
And that means that it is unknown if the benefits of an EUA product outweigh its harms because neither the benefits nor the harms are known.
Nonetheless, her slide above reads: “Issuance of an EUA requires a determination that the known and potential benefits of the investigational product outweigh its known and potential risks.”
Did Gruber know that EUA Products are Non-investigational?
Almost certainly. As Director of Vaccine Research and Review at CBER (which belongs to the FDA) she must have been familiar with the regulatory and legal meaning of an Emergency Use Authorization. If for some strange reason she would not have been, then FDA’s legal counsel should have brought her up to speed.
But there is pretty compelling evidence that Gruber knew very well that EUA products fall completely outside of the realm of investigational product development.
This evidence was discovered and archived by Katherine Watt: Two months before the October 22, 2020, VBRPAC meeting, another important meeting took place as part of what was called “Preparedness Summit,” organized by the FDA. The summit was for federal health agency employees only.
One of the summit’s meetings was a “FDA-CDC Joint Learning Session” with the title “Regulatory Updates on Use of Medical Countermeasures.”
At this meeting, FDA and CDC employees were told the truth about the dramatic regulatory ramifications of Emergency Use Authorizations.
This learning session was led by Elizabeth Sadove. Back then, Sadove was the Director of Medical Countermeasures Regulatory Policy at FDA’s Office of Counterterrorism and Emerging Threats (OCET).
Gruber, as the Director of the Office of Vaccines Research and Review within FDA’s Center for Biologics Evaluation and Research (CBER), certainly would have crossed paths with Sadove during the Pandemic and very likely earlier as well.
Its hard to imagine that their roles would not have intersected during the months leading to EUA authorization since Sadove dealt with the legal authority for EUAs, while Gruber’s job was to research and review new vaccines.
In fact, a document from the Senate Homeland Security and Governmental Affairs Committee (HSGAC) references both Sadove and Gruber in email chains related to FDA vaccine regulatory actions.
If Gruber had questions about the regulatory meaning of EUAs, she likely would have turned to Elizabeth Sadove for answers. Therefore it appears very unlikely that Gruber would have been ignorant of the fact that EUAs by-pass the regulatory pathway the FDA created for investigational products.
Good Manufacturing Practices Were “Loosened” for the EUA Shots
Since EUA products are non-investigational products, they do not necessarily have to comply with the FDA’s Good Manufacturing Practices (GMP).
This is what the law says (21 U.S.C. § 360bbb-3):
For the Pfizer and Moderna shots, Good Manufacturing Practices were not waived completely but the inspection enforcement was “loosened” by allowing “remote” inspections instead of in person inspections. That was just one of apparently many operational deviations from Good Manufacturing Practices.
The Chart that Tells the Truth
One of the slides in Elizabeth Sadove’s Preparedness Summit slideshow nicely shows the stark differences between non-investigational EUA products and Investigational products (IND and EAU):
The column ‘Clinical Trial’ in the table above should have been titled IND (Investigational New Drug). It doesn’t make sense to call it ‘Clinical Trial’ because the table shows the differences in information resulting from clinical trials for the three different regulatory pathways IND, EAU and EUA.
As you can see, the informational gain from clinical trials depends on whether it’s an investigational product like an IND, an Expanded Access Use or an EUA product.
Let’s zoom in on just the EUA pathway and what can be said about safety and efficacy of an EUA product after clinical trials:
Devastating, right? And it means that FDA and CDC employees heard the truth about EUA products during the Preparedness Summit. It stands to reason that Gruber knew as well.
An EUA product is in a regulatory class in its own, so much so that you never ever really want to take such a product because it’s too risky. It’s like playing Russian roulette. Neither you nor anyone else knows what might happen to you.
Let’s have a look at what the table above actually says:
A clinical trial for a product under EUA doesn’t produce any indications about efficacy: it is not likely “to inform effectiveness.”
Safety signals might be identified for EUA products during a clinical trial. Or might not be.
Clinical trials for EUA products are not likely to result in useful data that could benefit future patients.
An Institutional Review Board that oversees clinical trials is not required.
An EUA product is a black box: it’s not clear if it helps cure the disease it’s used for; it’s not clear whether and how much it harms the person taking the drug. Neither its benefits nor its risks are known.
What Marion Gruber Instead Told VRBPAC Members
Below, Gruber tells the committee members in bolded text that “FDA must ensure that vaccines that are approved or authorized under EUA are supported by adequate scientific data and clinical data.”
It’s, as we already know (and as Gruber almost certainly also knew), an impossibility for anyone, including the FDA, to ensure this. Elizabeth Sadove had told FDA employees two months earlier that there are no scientific and clinical data in EUA products that would allow such an assessment.
The bolded text is from Gruber (I added the red box around the bolded text):
Or look at what Gruber says here:
Unapproved products (meaning: EUA authorized products) mean investigational products? Not according to US law as we saw further up. This is plainly wrong - but who among the VRBPAC members would have known?
Below, Gruber talks about “expedited” vaccine development. She means EUA products of course. And what she says is false:
What she doesn’t say is that the FDA’s “scientific rigor”, standards and regulatory decision making are deliberately thrown over board for Emergency Use Authorized products. It’s an emergency: there is no time for scientific rigor, standards and regulatory decision making. That’s the whole idea behind EUA products. But the committee members don’t know that, at least most of them had likely no clue.
She never tells her audience that EUA products are completely outside of the FDA’s usual decision making process. That they are truly experimental emergency products of the last resort in absolutely desperate situations when people are willing to take an unproven drug in the face of otherwise certain death.
EUA Products Cannot Meet Legal Requirements for Safety and Effectiveness
Look at the excerpt from the meeting’s transcript below. Here, Gruber says that the FDA must make sure that EUA products meet “the legal requirements for safety and effectiveness are met.”
What she doesn’t say is that there are no truly meaningful legal requirements for safety and effectiveness for EUA products. None.
What she also doesn’t say is that the “best available scientific and clinical evidence” for EUA products is so shoddy and so limited that it doesn’t allow judging the risk-harm ratio of such products.
And again she talks about “investigational products under Emergency Use Authorization” - something that doesn’t exist.
As we have seen further up, the legal requirements for EUA products are completely different from the legal requirements of investigational products. They are so low that it’s not possible to know whether EUA products are safe and whether they are effective.
FDA officials Had No Clue about the Effectiveness of the Covid Shots in October 2020
Gruber makes a remarkable admission in her presentation: the FDA had no clue whether the “vaccines” would be effective or not.
Incredibly, barely two months before the EUA product was approved by the VRBPAC committee at a point in time where already millions of doses of the shots had been manufactured, she admits the “current lack of an immune marker that will predict effectiveness.”
From the meeting transcript:
FDA Officials Knew About the “potential for vaccine-induced enhanced disease”
Also remarkable is that Gruber alerts the VRBPAC committee to the danger that the “vaccine” would cause Covid-19 and a particularly severe form, “enhanced disease.”
Again, that was two months before the Pfizer and Moderna shots were EUA approved. And it was at the same time when tens of millions of doses had already been manufactured.
The whole thing was rigged from the start with the VRBPAC meeting in October 2022 playing a small but important role in the stitch-up.
CHAPTERS
00:05 Introduction: What Is the October 2020 VRBPAC Meeting and Why It Matters
03:00 Understanding CBER and the VRBPAC Advisory Committee
06:33 How VRBPAC Votes Work — and Why They Are Non-Binding
08:08 The Revolving Door: Paul Offit and Regulatory Capture
09:00 Why This Meeting Had No Vote — No Data Had Been Submitted Yet
09:17 Who Was in the Room: Federal Agencies, Outside Academics, and Pharma
11:47 Dr. Marion Gruber Opens: Her Role and Her Opening Promises
12:58 The First Key Legal Misrepresentation: EUA Products Are Not Investigational
16:01 CMC: Chemistry, Manufacturing Controls - The Documentation Never Released
16:34 Promises of Safety and Efficacy With No Data in Hand
23:37 The Intent to Deceive: FDA Legal Counsel Approved the Misrepresentations
32:01 Conflating EUA With Standard Biologic Licensure
35:39 Manufacturing Standards, Facility Inspection, and the GMP Requirements
39:28 Creating the Illusion of Regulation — Vaporware of Oversight
45:20 The Case for Congressional Investigation of FDA Legal Counsel
48:40 No Informed Consent Under EUA
49:09 The Fact Sheet as a Waiver of Informed Consent Rights
53:17 Peter Marks Orders Vaccinators to Stop Providing Fact Sheets
54:30 The August 2021 Full Approval: A Fake BLA to Enable Mandates
59:24 The FDA’s October 2020 Emergency Use Authorization Guidance Document
1:03:03 “Investigational” Bolded in the Slides
1:07:25 A Series Is Needed — Every Presentation Deserves Its Own Episode
