Tag: pfizer

FDA Orders Pfizer to Add PARALYSIS WARNING to RSV Vaccine Labels

Last Wednesday, the FDA ordered Pfizer and GSK to add Guillain-Barre Syndrome (GBS) as a serious adverse event risk warning to both Pfizer’s Abrysvo and GSK’s Arexy Respiratory Syncytial Virus (RSV) vaccine labels.

RSV is the leading cause of respiratory infection in adults over the age of 60. Prior to 2023, the CDC has not published data on the incidence of RSV death in babies and children. In 2023, the CDC estimates that approximately 100 children under the age of 5 died from RSV. Despite these low numbers, the CDC recommends that pregnant women receive an RSV vaccine to ‘protect’ their baby from RSV.

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Pfizer’s secret documents reveal that their COVID vaccine actually made you 8.7% more likely to get COVID

Pfizer tested all participants in their Phase 3 trial for N-antibodies. The results were kept hidden from the public. It was only through court order that we finally know what the results were.

Do you think they would have kept this data secret from the public if it showed good news? Heck no!

The table showed that Pfizer only had around 50% protection if you just take the table at face value. But if you interpret the table correctly, it shows Pfizer had negative efficacy.

In this article, I’ll show you how to properly interpret that data and get the truth.

The method was first disclosed by Jikkyleaks on May 24, 2022.

I recently became aware of it after independently replicating his work. I believe his numbers are slightly off, so I’ll show you the proper calculation for the correct estimate of the case counts.

No doubt about it; those who took the shots were more likely to be infected by COVID by 8.7%.

There is just no other way to interpret the Pfizer data. It’s “gold standard” clinical trial data.

The overall counts are too small for the result to be statistically significant. But the FDA should NEVER be approving a vaccine where the primary endpoint efficacy (reducing cases vs. the unvaccinated group) is so small to be statistically insignificant.

In plain English, the best estimates are that there were actually more infections in the vaccine group than the placebo group. Whoops!

This is a major failing of the FDA to recognize this.

It won’t be long before Senator Ron Johnson brings this to their attention.

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FDA’s Own Study Finds DNA Contamination in Pfizer Vaccines

A peer-reviewed study performed at a U.S. Food and Drug Administration (FDA) laboratory by high school students has confirmed the presence of a high level of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.

The study, published Dec. 29, 2024, in the Journal of High School Science, was authored by three students at Centreville High School in Clifton, Virginia, and performed under the supervision of FDA scientists.

Maryanne Demasi, Ph.D., an investigative medical reporter, was the first to report on the study.

The research, performed at the FDA’s White Oak Campus in Maryland, found that levels of residual DNA in the Pfizer COVID-19 vaccine were 6 to 470 times higher than regulatory safety limits. The students tested two lots of the vaccine, finding they contained “residual DNA to a level that exceeds 10 ng [nanograms] per dose.”

“The potential health risk posed by residual small DNA fragments is currently unknown,” the study stated. However, the authors also said that DNA contamination may result in insertional mutagenesis — or DNA mutations — that can cause cancer.

Speaking last month on “The Defender In-Depth,” Kevin McKernan, who first identified DNA contamination in the shots in 2023, said DNA in vaccines can pose health risks because the DNA “could integrate into the genome and cause disruption of the genome … or it could disrupt other genes that are related to cancer.”

The FDA did not respond to multiple requests for comment on the study.

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Two undisclosed deaths in Pfizer Covid vaccine trials

Pfizer-BioNTech did not disclose the deaths of two participants in its COVID-19 vaccine clinical trials before the FDA granted emergency use authorization (EUA) in December 2020. Documents released nearly three years later revealed the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman, both classified as “sudden cardiac death.” Researchers have criticized Pfizer for failing to report these incidents within the required 24-hour timeframe, with one case taking 37 days to be filed.

Dr. Jeyanthi Kunadhasan, an Australian anesthesiologist and researcher with the watchdog group Daily Clout, called for an investigation by Kansas Attorney General Kris Kobach. She raised concerns that withholding this information may have impacted the perception of the vaccine’s safety profile.

“If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths.”
— Dr. Jeyanthi Kunadhasan, Anesthesiologist, Daily Clout

These revelations are part of a broader controversy surrounding transparency. In 2022, a federal court ordered the FDA to release 1.2 million pages of clinical trial documents after rejecting a 75-year delay request. This included the trial data that Pfizer had an opportunity to disclose to the FDA’s Vaccines and Related Biological Products Advisory Committee but did not.

Kansas Attorney General Kobach has also filed a lawsuit against Pfizer, accusing the company of misleading the public about the vaccine’s safety and effectiveness. The suit alleges the company failed to disclose risks like myocarditis, pericarditis, failed pregnancies, and deaths while promoting the vaccine as “safe and effective.”

Pfizer classified the deaths as unrelated to the vaccine and omitted them from a December 2020 New England Journal of Medicine paper that lauded the vaccine’s safety and efficacy. Critics say this omission reflects a troubling pattern of selective reporting.

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The CFR from the Pfizer trial show the vaccines make you 14x more likely to die from COVID

The case fatality rate (CFR) from the Pfizer trial shows you are 10X more likely to die if you get COVID and you are vaccinated.

Pfizer just forgot to point this out.

Same with the CDC and FDA. I’m sure they just forgot.

So I’m going to show you that the CFR is 10X higher for Pfizer and when you combine that with a 40% higher likelihood of being infected, we can now estimate that the COVID vaccine makes you 14X more likely to die from COVID. And that’s not counting your risk of all-cause mortality from the vaccine itself!

The Pfizer Phase 3 study CFR calculation

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months showed for COVID deaths/cases:

Vaccinated: 1/8=.125
Unvaccinated: 2/162=.0123
Note: the deaths are in Table S4 in the Supplementary material

You were actually 10X more likely to die from COVID if you were vaccinated and you got COVID.

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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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Judicial Bombshell: Federal Judge Forces FDA to Release Over a Million Pages of Pfizer’s COVID-19 Trial Documents They Wanted to Keep Hidden for 75 Years

The United States District Court for the Northern District of Texas ruled against the Food and Drug Administration (FDA) in a high-profile case brought by the Public Health and Medical Professionals for Transparency (PHMPT).

The decision mandates the FDA to release the Emergency Use Authorization (EUA) file for the Pfizer-BioNTech COVID-19 vaccine no later than June 30, 2025.

The case stemmed from a Freedom of Information Act (FOIA) request by the PHMPT, which sought comprehensive data related to the Pfizer-BioNTech COVID-19 vaccine.

The FDA initially claimed it would need up to 75 years to process and release the requested documents. However, the Court, presided over by Judge Mark Pittman, rejected this argument, citing the importance of government accountability.

In late 2021, the U.S. Food and Drug Administration (FDA) faced significant public scrutiny after proposing a timeline that would extend the full release of documents related to the approval of Pfizer-BioNTech’s COVID-19 vaccine over several decades.

This proposal emerged following a Freedom of Information Act (FOIA) request by the Public Health and Medical Professionals for Transparency (PHMPT), a group of scientists and public health professionals seeking comprehensive data on the vaccine’s approval process.

The FDA initially suggested releasing 500 pages per month from a collection exceeding 300,000 pages, effectively delaying complete disclosure until around 2097. The agency cited limited staffing and the extensive volume of documents as reasons for this prolonged timeline.

In response to the backlash, U.S. District Judge Mark Pittman in Fort Worth, Texas, issued a ruling in January 2022 that significantly shortened the FDA’s proposed timeline.

Judge Pittman ordered the agency to release 55,000 pages per month, ensuring that all documents would be made public by the end of September 2022.

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DNA Contamination In Pfizer COVID Vaccines Up To Four Times Legal Limits, Study Finds

Researchers found DNA in Pfizer’s COVID-19 vaccines at levels three-to-four times higher than regulatory limits, according to a new “bombshell” study.

“This far exceeds the maximal acceptable concentration of 10 ng [nanograms] per clinical dose that has been set by international regulatory authorities,” the authors wrote.

The peer-reviewed study, published this week in the journal Science, Public Health Policy and the Law, also found simian virus 40 (SV40) DNA contaminants in the vaccines. And the researchers determined that the spike proteins produced by the vaccines persist in the body longer than claimed.

The findings led the authors to call for “an immediate halt of all RNA biologicals.”

Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense (CHD), told The Defender that DNA contamination may contribute to the increase in autoimmune diseases among the vaccinated. “The immune system operates on very sensitive detections to initiate responses,” he said.

“DNA suddenly deposited into your bloodstream could kickstart the interferon response,” Jablonowski said. “The interferon response, when there’s nothing to find but ‘self,’ could be the springboard for autoimmune disease.”

The study also showed that the spike proteins produced after vaccination persist in the body for at least seven days following vaccination instead of the shorter period Pfizer-BioNTech previously claimed. The spike proteins are also prone to shedding.

These results “raise grave concerns” about mRNA vaccines, the study concluded.

Kevin McKernan, founder of Medicinal Genomics, is the first scientist who identified the presence of SV40 in the mRNA vaccines. He called the new study “a tour de force on the DNA contamination topic.” McKernan wrote about the study on Substack, and said in an X post that the study’s authors “knocked it out of the park.”

Immunologist and biochemist Jessica Rose, Ph.D., agreed. “This paper is the paper of the century. The paper is not only a work of art in terms of the study layout. It is very well-written and settles ongoing ‘issues’ pertaining to allegations made by regulatory bodies that the DNA contamination issue is misinformation,” Rose said.

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Pfizer pregnancy trial showed the COVID shots increased AESIs (like major congenital abnormalities) in newborns by over 4X

Pfizer recently updated the results of their randomized clinical trial of the COVID shots on pregnant women entitled “To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older. ClinicalTrials.gov ID NCT04754594.

This prompted me to have a second look at these results which were first posted on July 14, 2023, over a year ago.

Did you know that the study showed that if you were assigned the vaccine, your child had a stunning 4.2X higher rate of AESIs such as MAJOR congenital abnormalities and developmental delays in just the first 6 months after birth?

Because the trial enrolled fewer women than planned, the effect size reached only the 90% level of significance. Based on just this trial, we are 90% certain that the vaccines made things worse. However, when you look at other data, the certainty approaches 100%.

4.2X is jaw dropping for an effect size for these types of major birth defect adverse events.

Was there a benefit? Nope. Moms in both groups got the same number of COVID infections (2 in each group). Vaccine efficacy estimated at a measly 3.8 (because the groups were different sizes). A perfect vaccine is 100. A vaccine which does nothing is 0. The 3.8 value was both tiny and NOT statistically significant. It’s entirely possible that the vaccine increased your risk of getting COVID. We can’t tell from the study.

This was all known more than 5 months ago when the results were first posted.

Why didn’t the CDC warn women that they were wrong?

This double-blinded placebo controlled trial which is considered to be the best evidence in medicine shows that it’s 90% likely it made things worse.

It’s Pfizer’s own data published on Clinical Trials.gov using gold-standard DB-RCT methodology. Anyone can analyze it. It’s in plain sight. Doesn’t get any better than this.

Today, more than 5 months after the lack of any COVID benefit was published on the NIH website (clinicaltrials.gov), the CDC is still silent on this.

Is the entire medical community blind, ignorant, or just corrupt? NOT A SINGLE MAINSTREAM doctor is speaking out. NOT ONE.

Dr. James Thorp got fired for speaking out about the vaccine harms to pregnant women so he’s not mainstream anymore since he’s out of the system. One of the few honest doctors and he gets fired. What does that tell you? His research which has been published in peer-reviewed journals, confirms the results of the Pfizer trial. In spades.

We have a very corrupt medical system where everyone is afraid to tell the truth.

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