Tag: vaccines

There is no scientific definition of vaccine in US biological product law.

Reader question:

Is there a formal definition of vaccine in law?

My reply:

There is no scientific definition of vaccine in statute or regulation.

That’s why I urged Kirk Moore to ask DOJ to provide proof that what they supplied to his office was a vaccine.

DOJ can’t provide that proof, because the proof doesn’t exist.

Congress added the term ‘vaccine’ to the biological products law in 1970 for the first time but did not define the term or direct the executive agencies to adopt or promulgate scientific definitions in regulations.

There is a financial definition of ‘vaccine’ and a definition based on the design intention, adopted by Congress in 1987.

1987/12/22 – Congress and President Reagan passed Omnibus Budget Reconciliation Act of 1987, PL 100-203, 101 Stat. 1330, including Sec. 9201, Manufacturers Excise Tax on Certain Vaccines, to establish an excise tax on vaccines ordered and purchased by US government and manufactured by private companies, to fund the Vaccine Injury Compensation Trust Fund established in 1986.

This act is the only act through which Congress has ever defined the term ‘vaccine,’ defining ‘vaccine’ as “any vaccine (A) which is listed in the table contained in [26 USC 4131(b)(1)], and (B) which is manufactured or produced in the United States or which entered into the United States for consumption, use or warehousing.”

Congress in 1987 defined vaccine in the form that now appears at 26 USC 4132a(2) — “any substance designed to be administered to a human being for the prevention of 1 or more diseases” — but has never defined the term “vaccine” in physical, chemical or pharmacological terms, and neither has the HHS-FDA.

See Dean v. HHS, No. 16–1245V, 2018 WL 3104388, at * 9 (Fed. Cl. Spec. Mstr. May 29, 2018), cited in 86 FR 6249, HHS Final Rule, National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, “(defining ‘‘vaccine’’ as ‘‘any substance designed to be administered to a human being for the prevention of 1 or more diseases’’) (quoting 26 U.S.C. 4132(a)(2)).”

The lack of scientific definition for vaccine was reinforced/corroborated in 2011 by the US Supreme Court in Bruesewitz v. Wyeth, when the majority opinion stated at p. 13:

“Design defects…do not merit a single mention in the [1986 National Childhood Vaccine Injury Act] or the FDA’s regulations. Indeed, the FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.”

Justice Scalia did not write, but it is also true, that FDA has never spelled out in regulations the criteria it uses to identify a product as a vaccine.

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Will Congress Thwart RFK Jr.’s Data Audit and Recall of the COVID-19 Shots?

Congress’s December 4, 2024, Coronavirus Pandemic Report has inspired hope for justice in prosecuting US federal agencies and individuals who engaged in egregious acts of willful injury against Americans and global citizens (i.e. Dr. Anthony Fauci), while frequently citing 18 U.S.C 1001 (that it’s a crime to lie to Congress).

The Congressional report also ignited controversy amongst many members of the medical freedom movement. The major point of controversy comes from one bullet point on page-2 of Chairman Brad Wenstrup’s opening letter for the 557-page Subcommittee report.

“Operation Warp Speed was a tremendous success and a model to build upon in the future. The vaccines, which are now probably better characterized as therapeutics, undoubtedly saved millions of lives by diminishing likelihood of severe disease and death.”

This statement, combined with Trump’s and RFK Jr.’s recent Mar-a-lago meeting with the CEO’s of Pfizer, Eli Lilly, and PhRMA, are causing many health freedom leaders to contemplate if every current and even future government official of our federal, legislative and judicial branches under Trump is inevitably a “deep state operative.” Some medical freedom influencers continue to assert that we are simply watching more “good cop, bad cop theatre.”

A key question naysayers raise is, “Why would House Representative Wenstrup make a key point in the Coronavirus Pandemic Report be, ‘The COVID-19 vaccines undoubtedly saved millions of lives,’ unless everyone involved in the government, including Congress, were deep state operatives?”

Because Naysayers and Their Followers Only Read the 1st Two Pages of the 557-Page Report

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President Trump Named TIME Magazine Person of the Year, They Refuse to Use His Iconic Image, and Slap Him with a Fake Fact-Check

President Donald Trump was named TIME Magazine Person of the Year on Thursday morning.

TIME Magazine refused to use the iconic image of President Trump facing the assassin’s bullet.

That would be obvious and too honest for the TIME staff.

TIME also couldn’t help themselves and fake fact-checked President Trump on the link between vaccines and Autism.

TIME says without hesitation that there is no link. They got this from Big Pharma.
Millions of Americans today would disagree.

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Pfizer Accused of Hiding Deaths in COVID-19 Vaccine Trials, Including ‘Subject 11141050’ in Kansas, Team Research Alleges

A team of researchers analyzing Pfizer’s clinical trial data has accused the pharmaceutical giant of concealing deaths during its COVID-19 vaccine trials.

Among the allegations is the failure to disclose the death of a Kansas participant who was part of the BNT162b2 vaccine trial. The death reportedly occurred 41 days after the participant received their second vaccine dose.

The accusations stem from a detailed report led by Dr. Jeyanthi Kunadhasan, an anesthetist and perioperative physician, and a member of the DailyClout research team.

The team alleges that Pfizer’s reporting practices during the critical juncture leading to the FDA’s Emergency Use Authorization (EUA) for the vaccine were flawed, with significant delays in documenting serious adverse events, including deaths.

“The Polack paper disclosed six deaths — two in the BNT162b2 arm, and four in the Placebo arm. In the journal article and the EUA approval documentation[9], the six deaths covered the period of July 27, 2020, through November 14, 2020,” Dr. Kunadhasan wrote in a letter sent to Kansas Attorney General Kris Kobach, who filed a lawsuit against Pfizer.

“This letter will demonstrate that Pfizer-BioNTech possessed records showing that eight deaths, four in the BNT162b2 arm and four in the Placebo arm, should have been disclosed by Pfizer to the FDA.  In addition, the two undisclosed deaths presented a cardiac event signal in the clinical trial’s BNT162b2 recipients. One of the undisclosed deaths in the vaccinated arm of the trial occurred in Kansas,” she added.

Subject 11141050, a 63-year-old Kansas woman, participated in Pfizer’s clinical trial at a research site in Newton, Kansas.

Despite her pre-existing conditions, including hypertension and depression, she met the trial’s inclusion criteria and received her second vaccine dose on September 8, 2020. She passed away on October 19, 2020, with the cause of death determined to be sudden cardiac arrest.

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Revealed: The Hidden Pfizer Report That Shows Heart Conditions in the Vaccinated Getting Worse Over Time

I told you here about Pfizer’s abstract of its Interim Report 5, showing at least 23-40% higher risk of some heart-related conditions in the vaccinated, but that the MHRA, the U.K. medicines regulator, was withholding publication of the full report. As I said at the time : “In summary, if, as I suspect, MHRA is worried by the results in Pfizer’s ‘Interim Report 5’ then no wonder it is sitting on it.”

Well, MHRA is still sitting on the report but I’ve managed to obtain a copy. It looks like I was right – the detailed results in the full report are even more worrying than the Hazard Ratios in the abstract which I reported last time.

To recap: this is a report of a Post Authorisation Safety Study (PASS) of Pfizer’s Covid vaccine. National regulators routinely require pharmaceutical manufacturers to conduct PASS studies as a condition of authorisation of most new medicines. The regulators provide data to the manufacturer covering millions of patients registered in national healthcare systems. The manufacturer then conducts analysis, matched for things like age and sex, to determine whether the medicine has increased the risk of specified health conditions.

Let’s dive straight in. Below are some heart-related cumulative incidence graphs from Pfizer’s full ‘Interim Report 5’. You will immediately notice that the incidence for each type of condition is significantly greater in the Covid vaccinated (bad) – but we already knew that from the Hazard Ratios in the abstract. What’s worse is that the curves diverge over time, i.e., the relative incidence between vaccinated and unvaccinated increases over the time period of the data in the report (December 8th 2020 – March 21st 2022). I wonder what happened subsequently.

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FDA must disclose more COVID-19 vaccine records, US judge rules

A federal judge has ordered the U.S. Food and Drug Administration to publicly disclose more information underpinning its authorization of COVID-19 vaccines, after failing to persuade the court to end the public records lawsuit.

In a ruling, opens new tab on Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, ordered the agency to produce its “emergency use authorization” file to a group of scientists who wanted to see licensing information that the FDA relied on to approve the Pfizer-BioNTech coronavirus vaccine.

“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” wrote Pittman, appointed in 2019 by then-President Donald Trump.

The lawsuit, filed in late 2021, attracted attention after the FDA said it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.

The FDA declined to comment.

Attorney Aaron Siri, representing the Public Health and Medical Professionals for Transparency, welcomed Pittman’s order.

“The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” Siri said.

He said the agency was “hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.”

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Gates Foundation Awards $8.6 Million to Expand Development of Multi-Dose Pediatric Vaccines Using Novel Adjuvants

On Dec. 5, 2024, formulation technology company VitriVax, Inc. of Boulder, Colorado was awarded a two-year, $3.6 million grant by the Bill & Melinda Gates Foundation to help “fund development of a polio vaccine formulation for possible inclusion in combination pediatric vaccines.” “We are honored to be part of the global drive to protect children from polio infection and contribute to polio eradication efforts,” said VitriVax’s CEO Romulo Colindres, MD, MPH.1 2

According to Vitrivax, it “will be applying its proprietary Atomic Layering Thermostable Antigen and Adjuvant (ALTA) technology to new polio vaccine candidates composed of virus-like particles (VLPs) for use in future combination hexavalent (six in one) vaccines.” It noted that use of VLPs is being studied for the next generation of polio vaccines. VitriVax believes that its ALTA technology could “facilitate the co-formulation of multiple, otherwise incompatible, antigens in a single injection.1 2

New Adjuvant Technology Could Revolutionize Vaccines

On its website, Vitrivax acknowledges that there are “two central technological challenges” that often limit the expanded use of some vaccines. The first challenge is to maintain a vaccine’s thermostability—the ability to resist irreversible change in its chemical or physical structure—during transport and storage. The second is the need to give multiple doses of a vaccine to allow for the most robust immune response possible to infections. VitriVax believes that ALTA is a revolutionary technology that has the potential to enable the production of more thermostable, multiple-dose vaccines and, thus, “redefine the future of vaccine technology.”3 4

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Leading doctors sign HOPE Accord calling for the suspension of all covid mRNA “vaccines”

Thousands of doctors and healthcare professionals have signed a petition calling for the immediate suspension of all covid-19 mRNA products because they are contributing to an alarming rise in disability and in excess deaths. 

The online petition, known as the HOPE accord makes 5 calls for the international community concerning the covid mRNA vaccines that were given emergency use authorisation stating that “a growing body of evidence suggests that they are contributing to an alarming rise in disability and in excess deaths.”

The petition calls for “independent investigations to be properly resourced to allow a comprehensive re-evaluation of all covid-19 products. There must be a full exploration of mechanisms of harm to provide insight into their effect on the human body both short and long term.”

There are additional calls for immediate recognition and support for the vaccine injured. “The vaccine injured must be recognised and every effort be made to understand their conditions. Support should include readily accessible multidisciplinary clinics offering investigation and treatment as well as appropriate compensation for all those who have been harmed.” 

It also states, “The medical profession must lead by admitting we lost our way. By drawing attention to these medical and ethical issues surrounding the covid-19 response, we hope to validate and amplify the call to ensure the relevant facts and ensure vital lessons are learned. An honest and thorough investigation is needed, addressing the root cause that has led us to this place, including institutional groupthink, conflicts of interest and the suppression of scientific debate.” 

An open letter to the General Medical Council of the UK written by Consultant Cardiologist Dr Aseem Malhotra and copies in several leaders in health also refer to the petition of which he is a co-founder.  They include the chief medical officer, Sir Chris Whitty, the Chief scientific adviser to the British government, Patrick Valance and the secretary of state for health, Wes Streeting. 

Dr. Malhotra says that given the level of evidence of unprecedented harm, their position to not suspend the covid mRNA products is now untenable. Re-analysis of Pfizer and Moderna’s original randomised controlled trials on the covid mRNA products by independent experts that included the associate editor of The BMJ revealed a greater risk of serious harm from the vaccine than being hospitalised with covid. This rate of serious harm is 1 in 800 at two months suggesting harms are likely much greater as it does not take into consideration medium to long-term harms that include heart attacks, strokes and cancer. Conversely, the level of benefit in the highest risk group, those over 90, according to UKHSA data for 2024 is 1 in 7,000 to prevent a covid hospitalisation. In other words, at least eight times greater risk of harm than benefit in this group.

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Structures found in mRNA injection samples are neither “nanobots” nor contaminants; they are lipid nanostructures

Over the years, Dr. Ana Maria Mihalcea and Dr. David Nixon have done a lot of work documenting self-assembly nanotechnology in various injections including those marketed as covid vaccines.  They are not the only ones investigating the unusual microstructures in mRNA injections.  In July 2024, Young Mi Lee and Daniel Broudy published a paper in the International Journal of Vaccine Theory, Practice, and Research which reported these conspicuous microscopic objects as “nano-robots.”

Dr. Anne Ulrich gives a completely different perspective on what these objects are.   Responding to Lee and Broudy’s paper, Dr. Ulrich published an article in the same journal in September.

Dr, Ulrich, a biochemistry professor at the Karlsruhe Institute of Technology, has been working for 20 years on lipid bilayers and bio membranes.  She has seen a lot of lipid structures and the shapes they can make.

The “conspicuous microscopic objects in mRNA vaccines” interpreted as “nano-robots” is a misconception, she wrote. “Because the wide range of  different shapes can be readily explained in terms of self-assembling lipids (including cholesterol), as are used for transfection.”  She continued:

As conveyed [by Lee and Broudy] and elsewhere, the angular platelets discovered in the covid-19 injectables have a technical appearance that is reminiscent of microchips, the extended sheets and bubbles have been interpreted as graphene, and some of the soft ribbons and spirals look like parasites. Concerned readers and influencers are rightfully wondering whether well-documented phenomena are responsible for some of the injuries following vaccination? Or, as implied in said article, whether the manufacturer might even have covertly spiked the injections with “nano-robots” that can be “programmed” to spring into action?

Based on our scientific expertise and with full conviction, we would like to give reassurance that the abundant structures found in the mRNA vaccines are neither “nanobots” nor contaminants – but rather maturation and/or degradation products.

Here, we argue that the bizarre structures should not be considered alarming per se, as they are just made up of lipids. They clearly do not represent any allegedly “toxic protein secretions,” “long-lasting silica,” “graphene-coated polymers,” “conductors or semiconductors” or any other “undisclosed additional engineered components” made up of “not-natural/foreign material.”

[In this commentary] we shall look at the structure of lipid nanoparticles and explain their curious rearrangements into sheets, ribbons, filaments, spirals, tubes, chips, beads on a string and much more.No Nanobots in Vaccines – Just Lipids on the Loose: Commentary on Lee and Broudy (2024), Anne S. Ulrich, BA, MA, DPhil(Oxon), 10 September 2024

Joining Doctors for Covid Ethics in October, Dr. Ulrich discussed her article.

“Lipids are amphiphilic molecules,” she explained.  “Amphiphiles are known to self-assemble in many different sizes and shapes.”

The term “amphiphilic” comes from the Greek words “amphi,” meaning “both,” and “philos,” meaning “loving.” This refers to the property of a molecule having both hydrophilic (water-loving) and lipophilic (fat-loving) parts. “But this could [be not only fats but] also be peptides, polymers or any other amphiphilic components,” Dr, Ulrich said.

“Lipid molecules will assemble spontaneously into bilayers … when they are suspended in water.  And these bilayers make up what we call a cellular membrane,” she said.

She explained that pure lipids will close themselves up to form a hollow sphere shape but lipid mixtures or lipids with short chains can form other shapes such as long ribbons, which can grow in length and width and can stack into multilayers.  A Lipid ribbon will begin to coil or twist if it consists of chiral molecules. If a ribbon begins to twist it will give rise to a spiral or helix.  If the ribbon of the spiral grows in width, it can eventually close up into a tube. 

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New Study Finds Concerning Evidence of COVID-19 ‘Vaccine’ Shedding

A new study titled, Menstrual Abnormalities Strongly Associated with Proximity to COVID-19 Vaccinated Individuals, was just published in the International Journal of Vaccine Theory, Practice, and Research:

In Spring 2021, MyCycleStorySM launched a secure online survey to which 92.3% of 6049 respondents self-reported menstrual irregularities occurring after the rollout of the COVID-19 injectables. Each respondent served as her own control because prior to the rollout of COVID-19 vaccination, the vast majority had regular menstrual cycles. A subgroup of 3390 respondents were only indirectly exposed to COVID-19 vaccines or the SARS-CoV-2 virus. This subgroup reported 1) being unvaccinated for COVID-19; 2) having had no COVID-19 symptoms; and 3) no positive test for COVID-19, yet a substantial majority of these women, who were only indirectly exposed to COVID-19 injectables or COVID-19 infections still had many of the same menstrual abnormalities as the 2659 women who were directly exposed to a COVID-19 injection (798), or had COVID-19 symptoms (1347), or tested positive for COVID-19 (514). Generalized linear mixed modeling was used to examine the association (not assuming causation) between abnormal menses experienced after the COVID-19 vaccine rollout by respondents who were only indirectly exposed by some degree of proximity to persons. Chi-Square, Student’s t, Kruskal-Wallis or ANOVA tests were used to assess the statistical significance of the similarities of menstrual irregularities reported by the directly exposed and indirectly exposed groups.

The mean age of the entire cohort was 37.8 ± 0.1 years. The percentage of the indirectly exposed participants who reported being within 6 feet of a COVID-19 vaccinated person was 85.5%. Of these, 71.7% had irregular menstrual symptoms within one week and 50.1% had irregular menstrual symptoms within ≤3 days after exposure. When comparing daily proximity to a vaccinated person, the categories of “daily within 6 feet outside the household” versus “seldom/sometimes/daily outside 6 feet” had the highest relative risk at 1.34 (p<0.01) for heavier menstrual bleeding, early menses at more than 7 days early with a relative risk at 1.28 (p=0.03), and extended bleeding for more than 7 days with relative risk at 1.26 (p=0.04). Indirect exposure to COVID-19 vaccinated persons was significantly associated with the likelihood of the onset of menstrual irregularities. This study provides additional data to complement a growing body of evidence raising concerns regarding the safety of mRNA vaccines.

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