Tag: vaccines

Was My Paper on Flu Vaccine Studies a “Hot Potato” for Editors?

Ithink the answer is “yes,” but here is the story for you to judge.

Each year the CDC publishes estimates of the effectiveness of the flu vaccine in the previous season. Reported by several networks, these estimates are based on a research design that is called a test-negative case-control study.

Over the years, the various authors have shared a similar analytical strategy: Early respiratory events were considered differently from later respiratory events (on the assumption that no effect is expected until immunity is built up). “Early” has typically been within two weeks post-vaccination.

Several months ago, I realized that this special handling of early events is a source of bias called “immortal time.” To expose the bias, I used causal diagrams, formally called “directed acyclic graphs (DAGs).” DAGs were introduced in landmark publications from the 1990s and are widely recognized in epidemiology as a methodological tool.

I wrote a short paper with a scary title: “Immortal time bias in test-negative studies of the flu vaccine.” I illustrated the bias by two simple DAGs that encoded the analytical approaches as described in those CDC-associated studies. The paper may be summarized in three bullet points:

  • Immortal time is an overlooked bias in test-negative, case-control studies of the flu vaccine.
  • The causal structure corresponds to misclassification bias or selection bias, depending on how early events were handled.
  • The bias can be avoided by considering all events and estimating built-up vaccine effectiveness by consecutive post-vaccination days.

I submitted the paper sequentially to three respected epidemiology journals. Surprisingly, the editor-in-chief of each journal rejected the paper within one week using boilerplate text. It was not sent for peer review. Why?

There are three possible reasons:

  1. The message was not sufficiently important.
  2. The paper was poorly written.
  3. Soliciting peer review was not needed. The editor decided that the bias did not exist. 

I can quickly eliminate the first reason. Exposing entrenched bias in studies of the annual flu vaccine is of utmost importance. I didn’t need to compete with any “more important” papers.

Was it poorly written? I have published many scientific papers and two books. I am not a newcomer to epidemiology and even served as an associate editor for one of the three journals. So, that was not the reason.

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Shapiro Tries To Arm Pennsylvania Health Bureaucrats With Warrantless Entry Powers And Forced Vaccine Databases — Voters Already Said No Once

Pennsylvania Governor Josh Shapiro is pursuing autocratic powers for public health that Pennsylvania voters removed five years ago, and he is doing it behind the scenes through regulations not legislation.

A 502-page proposal for modifications to the Pennsylvania health code, published on August 8, grants the Pennsylvania Department of Health vast new powers to enter premises without warrants, access medical records without consent, direct a statewide vaccine data system, impose masking mandates during an outbreak, as well as masking mandates in an effort of “prevention” for any “condition” the department has determined warrants an intervention.

It is important to digest the implications of this. The proposed regulations define “condition” to mean “noninfectious medical ailment or other health-related event”. That gives far reaching powers to the department of health in the guise of public health.

“The administration’s draft rules on masks and infectious diseases are deeply troubling,” said Pennsylvania lawmaker Michele Brooks. “These include standards that establish ‘rule by fiat’ for the imposition of masking, distancing, and virtually any other disease control measures; a state vaccine registry with mandatory reporting; the power to control attendance at funerals; and the broadest powers to track and collect private health information and to enter private property.”

Pennsylvanians know where this goes. Former Governor Tom Wolf instituted some of the most draconian COVID-19 lockdown orders in the U.S. from March 2020 to June 2021. Shapiro, then Attorney General, issued the mandates, and in defense of the state’s school mask mandate, called concerned parents “self-centered” in a 2021 filing to the Pennsylvania Supreme Court.

The Supreme Court ultimately handed down a judgment against Shapiro, ruling the Department of Health acted outside of its authority. However, the Court did write that the Department of Health had the ability to change its own rules. Shapiro seems to have taken this to heart.

In May 2021, Pennsylvanians passed a constitutional amendment constraining governors’ emergency powers to three weeks. Shapiro’s regulatory maneuver is designed to circumvent this democratic outcome entirely, granting a permanent, non-emergency power to a department he controls.

Randall Wenger, chief counsel of the Independence Law Center, fearful that health care workers will be allowed to access schools and interrogate children in private, said that parents deserve the right to care for their children as they see fit. “These regulations allow a bureaucrat to go into a school to meet with a child without parents’ knowledge and telling the school officials that they can’t even interfere with this. That’s unconscionable,” Wenger told The Daily Wire.

Shapiro comes from the Democrat buzz saw of presidential candidates and is potentially running in 2028. What he is doing in Pennsylvania is not public health — it is building a system of surveillance and compliance to be used nationwide. Pennsylvania did not vote for this system. Shapiro is doing it anyway, and whether the legislative branch steps in tells us how much the voters value the limits to power they voted for this year.

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FDA Acting Commissioner Woodcock Admits Adverse Events After COVID-19 Vaccination

This one email from FDA Acting Commissioner Janet Woodcock in May 2021 epitomizes everything wrong with our government’s treatment of vaccines and the vaccine injured.

Woodcock emails Fauci and Collins (head of NIH) to inform them that “a number of people” including healthcare workers she personally knows contacted her about injuries from every one of the available Covid-19 vaccines. She admits that:

(1) these injuries would not be picked up by FDA or CDC surveillance systems;
(2) there is no money set aside to study these harms (while billions are given to pharma companies for vaccines);
(3) no one will take these injured people seriously;
(4) no one knows how to treat them;
(5) there is no effort to study this serious issue; and
(6) “the industry” will not support the necessary studies.

I also agree with her sentiment that, “if you let a problem fester, then it will come back to bite you later…” Later is here.

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SUCH A FRAUD: Margaret Brennan Says Biden Regime Did Not Mandate Vaccines for Children – Then This Previous Video of Margaret Brennan Surfaces

It must be difficult being a mainstream media mouthpiece these days. You have to sort through the all the lies from yesterday to promote the newest set of lies you promote to the American public.

Take for example, Margaret Brennan.

The silly CBS News anchor thinks we forgot about the BS she was shoving down our throats about COVID not so long ago.

On Sunday, Brennan lectured the brilliant Dr. Mehmut Oz, the current administrator of the Centers for Medicare & Medicaid Services (CMS), that the COVID vaccines were NOT forced on American children.

This proves she has no respect for the American public to push such trash on her audience.

Here is Margaret Brennan with Dr. Oz on Sunday:

Dr. Mehmut Oz: “The question again, this comes back to a much more fundamental issue, Margaret. Do parents have the right to ask questions? We already experienced what happened during COVID when we took away that right from parents. They were forced to give their kids COVID vaccines.

Margaret Brennan: (interrupting) They were not forced to give their kids vaccines…

Dr. Mehmut Oz: Well, they were pushed hard and oftentimes hindered from doing what they wanted to do, like going out socially if their kids were not included in these programs…

Margaret Brennan: (interrupting) No, of course it’s not up to the state.

Dr. Mehmut Oz: It’s not up to the federal government. It’s up to the states. States do this. The request of the president is to make sure that states offer parents either eligibility because of religious beliefs or other reasons why they may not want to have their kids take all the vaccines in order. Let’s pick a specific example. Hepatitis B. Hepatitis B vaccine I happen to like. I got the hepatitis B vaccine, but it helps adults avoiding issues if they’re involved. For example, in my case as a doctor, if I were to hit myself with a needle with a patient, but it usually is for drug abusers and for people who are involved in — or infants who could be exposed by a caregiver, by someone in their house, by parent unwittingly, which is why it is provided extraordinarily.

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Science by press release: Moderna cashes in on mRNA cancer vaccine without publishing trial results

hen the Food and Drug Administration approved Moderna’s mRNA flu vaccine, the first ever, two weeks ago, the pharmaceutical company that reaped billions from federal taxpayers with its mRNA COVID-19 vaccine didn’t wait for the agency to even publicly post the approval. Moderna rushed out the news at 10 p.m., with a 4% increase in its share price the next morning.

It was a promising market signal for a drugmaker whose revenue cratered following the collapse in demand for COVID vaccines, which also led Pfizer to cancel a trial this spring for its own updated mRNA COVID jab. 

What Moderna left out of the release Wednesday, and the media ignored: the mRNA flu jab’s disproportionately high rate of serious adverse events compared to a normal flu shot – the same problem with its Omicron-specific COVID vaccine three years ago – and the number of jabs required to prevent a single hospitalization, 5,000.

Yet the market and the media went crazy for Moderna this week when it announced “positive topline results” from a late-stage trial of its cancer vaccine with Merck, with a 177% spike in its share price on top of a 357% increase this year before the cancer vaccine news, despite no published trial data or FDA approval. 

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Two New Studies Raise Alarm Over Potential COVID-19 “Vaccine” Contamination of the Blood Supply

A newly published two-part scientific study raises major alarms about an issue that has received remarkably little scrutiny: What happens when blood from COVID-19-vaccinated donors is transfused into another person?

Blood banks routinely screen donations for recognized infectious threats. Yet the current blood supply is not routinely screened for vaccine-derived mRNA, spike protein, plasmid DNA, amyloid, fibrin-microclot complexes, or other relevant vaccine-associated constituents.

Our newly published two-part series investigates this blind spot from two complementary directions. The two studies were authored by James A. Thorp, MD; Claire Rogers, MSPAS, PA-C; R. Clinton Ohlers, PhD; M. Nathaniel Mead, PhD; Nicolas Hulscher, MPH (myself); Kirstin Cosgrove, CCRA; Sierra Hamm, RN; David Speicher, PhD; and Steven Hatfill, MD, M Med.

Part I presents a retrospective, hypothesis-generating case series of nine individuals who had not received a COVID-19 vaccine and subsequently experienced serious medical events after receiving blood transfusions.

Reported complications included thromboembolic disease, progressive clotting disorders, myocarditis, pericardial disease, disseminated intravascular coagulation, multi-organ system failure, and death.

We concluded that these cases, together with the existing literature, raise sufficient concern to warrant direct investigation of whether biologically active vaccine-derived constituents may be present in donated blood:

This study suggests that blood donated by COVID-19-vaccinated individuals may contain biologically active vaccine-derived constituents that could cause adverse clinical outcomes. The case reports and cited studies identify questions that warrant further investigation. All the pathogenic components of the COVID-19 vaccine or byproducts from it, have been found in several studies to be circulating in the blood of vaccinated donors. Healthcare providers must honor the ethical principles of patient autonomy and non-maleficence and support patients’ requests for autologous and directed designated donor blood. Screening blood donations for the presence of spike protein, amyloid, fibrin-microclot complexes, vaccine-derived mRNA, and plasmid DNA using quantitative assays and PCR-based methods should be considered for further evaluation by relevant public health and regulatory authorities, including the CDC and FDA.

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Sanofi Didn’t Follow Protocol for Clinical Trial in Which Infant Died

Sanofi shut down its RSV vaccine trial for infants and toddlers in 2024 after a baby died. It was later determined that the baby had an underlying congenital heart defect, which should have disqualified the infant from participating in the trial.

Now, a newly obtained letter shows the company paused the trial “to re-educate all participating sites and investigators” on the criteria they should use to judge who should or shouldn’t be allowed to participate in the trial, and to “reiterate the need to assess for chronic illnesses” that would make an infant or toddler ineligible to participate in a clinical trial.

The letter — obtained through a Freedom of Information (FOI) request by British general practitioner and RSV vaccine expert Dr. Peter Selley — sheds new light on the infant death and trial pause first reported by The Defender.

The infant’s death constituted a “serious adverse event” that triggered the halt.

A Sanofi spokesperson last month confirmed the death and told The Defender that the baby had underlying congenital heart disease. The company’s analysis — supported by the independent data monitoring committee — the spokesperson said, concluded the experimental vaccine was not the “underlying cause of the event.”

Research published in the Pediatric Infectious Disease Journal indicates that most children who die from respiratory syncytial virus, or RSV, have comorbidities such as congenital heart or lung disease.

Congenital disorders should have excluded babies from the study, and participants should have been assessed for preexisting conditions, according to the clinical trial’s exclusion criteria.

“Given that they stopped the trial to ‘re-educate’ investigators about inclusion and exclusion criteria, it suggests that the trial protocol was not being followed in at least one of the trial sites,” Selley told The Defender.

Sanofi told The Defender that when the infant with an undiagnosed underlying heart condition died after receiving the experimental vaccine, the company proactively informed and worked closely with the independent data monitoring committee (IDMC) and health authorities to address the issue.

He said the U.S. Food and Drug Administration (FDA) put the trial on a clinical hold and the company worked “to amend the Phase 3 protocol, adjust and clarify screening procedures and inclusion criteria, and re-educate all participating sites and investigators.”

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Report Links Vaccines to the Explosion of Alpha-Gal Syndrome

Alpha-Gal Syndrome (AGS) is a potentially dangerous meat allergy that can suddenly make people react to beef, pork, lamb, dairy, gelatin, and other products made from mammals. Reactions can range from hives and severe stomach symptoms to life-threatening anaphylaxis, often appearing several hours after eating. And the condition is rising at an extraordinary rate: among adults being tested for alpha-gal antibodies, positive results increased roughly 100-fold between 2013 and 2024. A separate 2026 CDC study found alpha-gal antibodies in 24% of adults across five high-burden states.

To investigate what may be driving this surge, we conducted one of the most comprehensive reviews of Alpha-Gal Syndrome to date. Our new 104-reference paper, “Risk Factors, Pathogenesis, and Management of Alpha-Gal Syndrome,” is a major collaboration between researchers from the McCullough Foundation and The Wellness Company. It examines the causes, mechanisms, prevention, and treatment of AGS and raises a major overlooked question: could vaccine-derived alpha-gal be contributing to this explosion?

The Vaccine Connection

For years, tick bites have largely been assumed to explain Alpha-Gal Syndrome. But that explanation leaves several major questions unanswered. Tens of millions of Americans are bitten by ticks, yet only a minority become sensitized and only a fraction of those individuals develop clinical disease. Even the amount of alpha-gal actually delivered by a feeding tick has never been measured.

At the same time, more than 90% of U.S. children are exposed to alpha-gal-bearing mammalian gelatin through routine vaccination. A child completing the two-dose MMR and varicella schedules receives approximately 54 mg of mammalian gelatin by injection before school entry.

Eating mammalian products normally trains the gut to tolerate alpha-gal. Injection bypasses that pathway and introduces the material directly into immune compartments capable of promoting sensitization.

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Over 300,000 kids received Covid shot AFTER officials knew of myocarditis risk

New vaccination data obtained by RCR, alongside emails released earlier this year, reveal that 311,257 teenagers received a second dose of the Covid vaccine after officials and Vaccine Ministers had been advised of the increased risk of myocarditis following a second dose in young people.

An email from Dr Ian Town, the Covid-19 Vaccine Technical Advisory Group (CV TAG) chair, dated 12 August 2021, shows the group’s advice on myocarditis risk and the recommended dosing schedule for 12 to 17-year-olds had been accepted by Director-General of Health Ashley Bloomfield and communicated “in detail” to the Vaccine Ministerial Group.

The ‘Vaccine Ministers’ was an informal group with no terms of reference that was set up to help govern the management of New Zealand’s portfolio of Covid-19 vaccines, including the immunisation programme rollout.

Cabinet delegated decision-making authority to the Vaccine Ministers on certain aspects of the Covid-19 Immunisation Programme. Members were Chris Hipkins, Minister for Covid-19 Response and chair of the group; Prime Minister Jacinda Ardern; Finance Minister Grant Robertson; Health Minister Andrew Little; and Associate Health Ministers Dr Ayesha Verrall, Aupito William Sio and Peeni Henare.

The new data, along with the emails, helps join the dots about who knew what, when, and reveals the extraordinary scale of the teen population that subsequently received two doses.

Additionally, OIA documents obtained and reported on over several years, including in The People’s Position, The People’s Report and RCR’s myocarditis timeline, have documented discussions among CV TAG about myocarditis and pericarditis – including the elevated risk following a second dose, alongside consideration of vaccination schedules for young people.

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Over 1,000 Canadians seek to testify over alleged COVID vaccine injuries

More than 1,000 Canadians have applied online to testify about serious health problems they say they experienced following COVID-19 vaccination, according to organizers of an upcoming inquiry led by Conservative MP Dean Allison.

The Allison Inquiry is a non-partisan preliminary inquiry intended to give Canadians who report being injured by COVID-19 vaccines an opportunity to share their experiences.

The hearings are scheduled to take place on Parliament Hill from September 8 to 11, with approximately 50 Canadians expected to testify.

Allison, the MP for Niagara West, provided an update on the inquiry during a press conference in Ottawa on Thursday, saying the response from Canadians has been far greater than organizers anticipated.

“More than 1,000 people have now applied online asking for the opportunity to have their voices heard,” Allison said.

Allison said many applicants have spent years struggling with their health, looking for answers and attempting to navigate a medical system they believe has failed to address their concerns.

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