Official Submission to FDA for "Vaccines and Related Biological Products Advisory Committee"

Docket No. FDA-2025-N-1146 for Vaccines and Related Biological Products Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—
2025-2026 formula for COVID-19 vaccines for use in the United States.

Comment for consideration by Health Freedom Defense Fund, Inc.

Health Freedom Defense Fund is a non-profit 501(c)(3) that has successfully funded and pursued legal remedies for the violation of rights committed under public health emergencies, and for the inappropriate use of executive power outside of statutory guardrails (successfully challenged the Biden administration’s CDC travel mask mandate).

The Health Freedom Defense Fund insists that the FDA, and the VRBPAC specifically, must immediately recommend and/or act to withdraw the SARS-CoV-2 mRNA injections from its formula. This should happen due to three primary reasons:

Overwhelming safety signals and public concern—the reported severe adverse event (SAE) rate in the official reporting systems far exceeds any previous vaccination by an order of magnitude, including those that have been recalled in the past, like the Swine Flu vaccine (after approximately 25 deaths) and RotaShield (after 10–15 bowel intussusceptions). Systematic censorship by public and private actors of vaccine injury testimonials and pressure from clinics and hospitals to avoid scandal and “vaccine hesitancy” obscured the true rate of injury reporting in both VAERS (which only captures a fraction of injuries) and the media more broadly.
Unique legal immunity persists due to PREP Act and EUA designation—mRNA vaccinations are still considered a “covered countermeasure” due to the suspension of required legal and regulatory processes for this category of product under the PREP Act and the specific Emergency Use Authorization (EUA) for the products, even with subsequent “full” approval from the FDA. These are compounded by non-stringent supervision of manufacturing practices, the blurring of the lines between BLA and EUA application data, unavailability or alleged manipulation of underlying clinical trial data and limited post-licensing follow-up and enforcement by FDA officials.
Failure to provide promised public benefits—the miscategorization of this family of products as a vaccine, rather than more appropriately as a novel therapeutic, and the underlying failure of mRNA technology to produce the advertised and publicized outcomes of stopping transmission and protecting others has resulted in a generational shift toward distrust in the FDA, CDC, and HHS more generally. Advertisements to “protect others” without side effect warnings still can be seen and heard on mass media (unlike other vaccine advertisements, due to the PREP Act provisions), violating the basic principle of informed consent and engendering further lack of trust.

Due to these three primary factors of safety, nested legal immunity, and broken promises, the public has measurably lost trust in the agencies under the Department of Health and Human Services in a way that can only be repaired by responsible action by both this committee and FDA leadership. For that reason, and in the interests of public safety, an immediate halt to the inclusion of mRNA products pending further study is warranted.

Supplemental commentary for your consideration:

Reported rates of SAE, peer-reviewed evidence of harm, correction of key peer-reviewed studies by CDC officials

It is a rarely reported fact that there were more deaths in the intervention group than the control group in Pfizer-BioNTech’s original clinical trial report. Even within that data, adverse events like those experienced by Maddie DeGaray, one of the 1,131 participants in the 12–15-year-old Pfizer clinical trial, which included half-body paralysis within 24 hours of her second injection—a paralysis she experiences to this day—were listed merely as “functional abdominal pain” in her case, and she has received no follow-up or compensation. Pfizer told the public there were “no vaccine related serious adverse events” on May 27, 2021, in its publication on that trial. With cases like this, doubt is cast on the reliability of the clinical trial data submitted under EUA and its descendants under the BLA process.

Beyond the clinical trial period, this novel intervention has received more reports of injury in general, and childhood deaths specifically, in the VAERS and Vaccine Safety Datalink system than all vaccines administered to date in the system, despite pressure from (and upon) hospitals and clinics not to report side effects for fear of engendering “vaccine hesitancy.” Additionally, this system itself is almost certainly an undercount of the damage, as the VAERS system was determined to capture only 1% of vaccine injuries in a government-funded study by Harvard Pilgrim.¹ In the other direction, chance of false injury reports is negligible. This is due to the fact that SARS-CoV-2-related injuries carry a significantly lower chance of receiving compensation compared to previous vaccinations, given legal constraints. Almost all injuries sustained due to the mRNA injections during the last four years have not resulted in any legal, financial, or commensurate remedy. The already challenging process required under the National Childhood Vaccine Injury Act of 1986 has been compounded by the evocation of the PREP Act, which courts have repeatedly cited as providing a full protective tort shield against any person implementing a “covered countermeasure.”

Nearly every day, new peer-reviewed articles reveal the immediate and long-term aftermath of this family of products: clinical trial data shows how lipid nanoparticles accumulate in specific organs (most notably ovaries), how the allegedly temporary spike protein production continues to persist for years in patients and may cross the blood-brain barrier,² how menstrual changes are clearly demonstrated,³ and how batch variation drives outcomes.⁴

This occurred against the background of furtive moves at the regulatory agencies—these injuries and negative clinical outcomes occurred while the public’s primary source of information, the CDC, quietly changed its public definition of vaccine, changed its representation of how the injection stays at the site of muscular administration, and tolerated amorphous definitions of a SARS-CoV-2 “case” which made any rigorous population-level investigation nearly impossible, with the unblinded initial trials being the only (questionable, given it was conducted under EUA) source of rigorous information.

Legal immunity, institutional impunity

The legal cocoon that shrouds the mRNA injection is a result of compounding legislative protections. The National Childhood Vaccine Injury Act of 1986 provides general vaccine product immunity, the PREP Act serves to evoke emergency law provisions for SARS-CoV-2 as a covered condition, and the EUA for the two mRNA products’ inclusion as “covered countermeasures” against that condition. These nested legal protections result in an accountability-free environment, wherein no product can be “deemed adulterated or misbranded” by statute. Further, protections and quality assurance measures have eroded due to changes to the Federal Register by the FDA Commissioner Gottlieb since May 2, 2019, when the requirement for regular FDA inspections for even BLA biologics was removed (21 CFR 600.21).

Issues also remain with manufacturing processes for this specific product—for example, during the EUA proposal stage, there were two distinct processes that allowed a chemically distinct “Process 2” to be granted the same regulatory approvals for public use as “Process 1,” which Pfizer initially utilized to manufacture its product during the clinical trial. Overall, there are serious issues with the integrity of the BLA applications by Pfizer and Moderna, the data that was shared and how it was represented. Substantial allegations of data mismanagement during the clinical trial period were leveled and covered extensively by British Medical Journal and other peer-reviewed journals.⁵

Lastly, key peer-reviewed articles used to sway the public on mRNA vaccine safety for pregnant mothers, some authored by CDC leadership themselves, have been substantially corrected quietly in a way that no longer supports the headline assertions of “safe for pregnant women.” The researchers promised the New England Journal of Medicine upon correction that they would follow up to amend the data, which they have failed to do, and intentional destruction of CDC data among the researchers in this case is being alleged by a U.S. Senator.⁶

Broken promises and misrepresentations to the public

Simply put, the mRNA injection platform was a misrepresentation to the public. It did not deliver on the representations and fundamental promises made by the public-facing representatives of CDC, HHS, and the leadership of pharmaceutical companies themselves.⁷ In the original EUA clinical trial, reanalysis in The Lancet shows the actual risk reduction (ARR) for the reduction of a single nonspecific symptom—which does not include useful clinical endpoints like death, transmission, or severe outcomes—is lower than 1% for the Pfizer-BioNTech injection, a far cry from the 95% relative risk reduction advertised without caveat across the world.⁸

Indeed, Pfizer representatives admitted during testimony before the European Parliament that they did not study transmission in their clinical trials.⁹ “Fact-checking” of this testimony mainly emphasizes that this was not required for the EUA application, which does not address the issue that the heads of U.S. health agencies, and the President himself, stated publicly that the vaccine prevents “getting COVID,” “becoming a dead end to the virus,” repeatedly and in public.¹⁰

The largest observational studies from institutions like the Cleveland Clinic show increasing rather than decreasing rates of positive tests for infection with each subsequent mRNA injection.¹¹ Again, “fact-checking” online mainly emphasizes that this was not the study’s goal to discover, and that there could be (unsubstantiated) confounding factors, but does not actually claim the information in the study is incorrect.

Note on comments submitted so far: As of the morning of May 14, 2025, the public comment section for this docket is full of advocacy for approval for Novavax, with many comments noting the lack of efficacy or even dangerous profile of the novel mRNA technology options currently on the schedule. Even among those who think vaccination against SARS-CoV-2 is appropriate, there is little public appetite for the mRNA technology to complete that task. The primary backers of this technology are not the general public, nor even physicians or hospital systems, but rather those that have invested billions into the development and commercialization of the mRNA platform for multiple disease areas.

Official Submission to FDA for “Vaccines and Related Biological Products Advisory Committee”

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