Toxic Exposures
‘Profound Breach of Trust’: Pfizer Omitted Trial Data Showing Higher Mortality, Kidney Failure in Seniors Given mRNA Flu Shot
The trial data published in the NEJM last week focused exclusively on adults 18 to 64, even though nearly 60% of the Phase 3 clinical trial participants were 65 or older — suggesting Pfizer intends to heavily market its mRNA flu vaccine to older adults. The trial data omitted from the NEJM study, but published on ClinicalTrials.gov, revealed a high rate of serious adverse events among elderly trial participants.
Pfizer is facing scrutiny after the drugmaker last week published Phase 3 clinical trial results for its mRNA flu vaccine in the New England Journal of Medicine (NEJM) — but excluded the trial’s data for adults 65 and older.
The data, published only on ClinicalTrials.gov, showed that elderly participants who received the mRNA flu shot faced a greater risk of serious adverse events, including kidney failure and acute respiratory failure.
The trial results published in the NEJM last week focused exclusively on adults 18 to 64. The only reference to results for participants 65 and older appeared as a brief mention in an accompanying editorial.
Daniel O’Connor, founder of TrialSite News, said the NEJM’s exclusion of “a full high-risk cohort is extremely unusual and suggests a strategic de-emphasis of negative findings.”
“When a top-tier journal quietly omits an entire high-risk population — and that population shows no benefit and higher harm — you’re not looking at science. You’re looking at a profound breach of trust with reckless disregard,” O’Connor said.
Epidemiologist and public health research scientist M. Nathaniel Mead, Ph.D., called the exclusion of the data “a PR win” for Pfizer, but said it came at the exclusion of a population that is significantly more prone to flu-related illnesses.
“One reason the vaccine industry would not want to enroll large numbers of frail elderly persons is that this risks exposing embarrassingly low or rapidly waning efficacy, plus higher rates of side effects or even paradoxical harm,” Mead said.
Kidney failure among elderly a ‘significant safety signal’
Scientists who analyzed the clinical trial data for the 65 and older participants said the results show Pfizer’s mRNA flu vaccine poses a higher risk than existing non-mRNA flu vaccines.
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, told The Defender the 65-and-over portion of the clinical trial “accounts for the largest discrepancy of adverse events.”
“The mRNA group suffered a 7% elevated all-cause mortality (49 vs. 46), an 8% elevation in serious adverse events (318 vs. 296), and an astounding 80% elevation in non-serious adverse events (3,091 vs. 1,720),” Jablonowski said.
This was the case even though the mRNA and non-mRNA groups were almost identical in size.
Jablonowski said the researchers “also have to reconcile the dramatic differences of a 129% elevation in acute kidney injuries (16 vs. 7) and a 184% elevation in acute respiratory failures (17 vs. 6)” among participants who received the mRNA flu shot.
Jablonowski said the data show “a statistically significant 185% greater chance of acute respiratory failure for the mRNA product.”
In all, 22 participants were diagnosed with acute kidney injury, chronic kidney disease or end-stage renal (kidney) disease, according to investigative journalist Alex Berenson. He said this outcome is “worrisome” and a “significant safety signal.”
Writing on Substack, pharmacologist Maria Gutschi said it was “a big red flag when the vaccine causes all these kidney issues in the healthiest segment of an age group that is most at risk for kidney damage or decline.”
“You don’t want to give anything that increases the risk of kidney damage in this population,” Gutschi wrote.
‘Who would want to take that mRNA shot over the conventional one? Nobody’
Dr. Clayton J. Baker, an internal medicine physician, said the mRNA group also had a higher cancer rate.
“By my calculation of the raw data, in the 65-plus age group, the mRNA shots even had a higher rate of cancers (0.33% to 0.27%).” This is an important consideration given the multiple studies, including one in South Korea and one in Italy, showing links between the mRNA platform and increased cancer incidence, Baker said.
Gutschi said the profile of adverse events commonly reported among mRNA flu shot recipients, including fatigue, lymphadenopathy, fevers and pain, “looks identical to the COVID-19 mRNA shots.”
Microbiologist Dr. Carole Fouché said the findings show that the mRNA vaccine “is ineffective and causes even more deaths and serious side effects than the conventional vaccine, which is already very ineffective.”
According to data from the Centers for Disease Control and Prevention (CDC), flu shot effectiveness has varied greatly in the last 15 years, ranging from 19% to 60%.
Notably, Pfizer’s clinical study numbered approximately 45,000 participants from all age groups. Of these, nearly 27,000 — nearly 60% — were 65 or older.
According to Gutschi, exclusion criteria for participants were stringent. Participants “were by design healthy retirees” without serious comorbidities. Yet, the data Pfizer omitted from the NEJM analysis show higher all-cause mortality (0.36% to 0.34%) in the 65 and older group that received the mRNA vaccine compared with people in the same age group who received the conventional flu vaccine, Baker said.
“Who would want to take that mRNA shot over the conventional one? Nobody,” Baker added.
In the U.S., adults 65 and older have the highest risk of hospitalization or death from flu. They are also the group with the highest rate of flu vaccination in the U.S., with a coverage estimate of 69.7% during the 2023-2024 flu season, according to the CDC.
French scientist Helene Banoun, Ph.D. said the fact that 60% of participants in Pfizer’s clinical trial were 65 or older suggests Pfizer intends to heavily market its mRNA flu vaccine to older adults if it is approved.
“Pfizer certainly intended to sell its mRNA flu vaccine mainly to people over 65, since only 18,500 subjects ages 18-64 are included, compared to more than 27,000 subjects over 65,” Banoun said.
“With the prospect of another multimillion-dollar vaccine pipeline, the authors’ interests were in conflict with the science and interests won out,” Jablonowski said.
Pfizer trial suggests lipid nanoparticles may cause serious vaccine injuries
Some scientists suggested the profile of serious adverse events among the clinical trial participants who received Pfizer’s mRNA flu shot indicates that mRNA technology itself may be the cause — and, more broadly, may pose significant risks to human health.
In her analysis, Gutschi stated that while adverse events, including widespread inflammation, following mRNA COVID-19 vaccination were widely attributed to the presence of spike proteins in those shots, the results of the clinical trial for the mRNA flu shot indicate that lipid nanoparticles (LNPs) may be responsible for the significantly high rate of adverse events.
LNPs are intended to deliver mRNA to human cells. But they’ve also been found to deliver DNA contaminants, which have been found within the mRNA COVID-19 vaccines, throughout the body.
“The mRNA platform toxicity is not limited to spike [proteins], it may even be that the spike protein is just an accelerator of the damage done by the LNPs. This influenza trial is the best trial so far where one can hypothesize what the LNPs by themselves might be able to do,” Gutschi wrote.
Gutschi cited the high rate of kidney-related injuries in Pfizer’s trial. “Nephrotoxicity fits perfectly within this pharmacologic pattern,” Gutschi wrote.
Gutschi suggested Pfizer omitted the data on trial participants 65 and older to hide the evidence of harm caused by mRNA vaccine technology.
“This is what we call, a tell,” Gutschi wrote. “What those tables revealed wasn’t just a failed trial, but a clue to the central problem of the mRNA project: even without spike, the inflammatory signature persists.”
Banoun said Pfizer was not transparent about the dosage of the mRNA flu shot that trial participants 65 and over received:
“Those over 65 received a higher dose of mRNA than those aged 18-64, who received 30 micrograms. Yet, in the protocol published in the NEJM, the exact dose administered to those over 65 is hidden.
“Is it possible that the dose required to obtain a sufficient immunological response (in terms of antibody titer) is so high in those over 64 that the manufacturer did not dare to state it clearly?”
Other experts noted that Pfizer tested its mRNA flu shot against another vaccine and not against an unvaccinated control group, making it difficult to ascertain the true effectiveness of the mRNA vaccine in light of the significant fluctuations in the year-to-year effectiveness of the existing flu vaccine.
Concealing data could result in criminal liability for Pfizer
In an interview last week with investigative journalist Maryanne Demasi, Ph.D., Retsef Levi, a member of the CDC’s Advisory Committee on Immunization Practices, said the outcomes of Pfizer’s clinical trial and the omission of data from its NEJM paper call into question the integrity of the clinical trial system.
NEJM’s editorial brushed off concerns about the study and Pfizer’s exclusion of the data for elderly participants, claiming it was “reassuring that no safety concerns were identified with the modRNA [mRNA] vaccine in young adults.”
Mead said this is common practice in scientific journals, which “prioritize the well-powered primary endpoints of a study.”
According to Berenson, Pfizer has also “never publicly announced the failure of the trial.” In an October 2023 announcement, Pfizer said it would release the results of the clinical trial by the end of 2023 — but did not.
Instead, in May 2025, “Pfizer quietly updated the ‘study results’ page for the trial on the clinicaltrials.gov Website with trial’s results,” Berenson wrote. “Instead of coming clean about the [study’s] failure, Pfizer has instead chosen to publish results from the part of the trial that covers younger adults, the 18-to-64 group.”
O’Connor said concealing the data could result in criminal liability for Pfizer, “if it can be shown that there was intentional deception, material harm or foreseeable risk, and collaboration with Pfizer to conceal the data.”
“Pfizer’s long history of criminal fraud, stretching back decades, involving dozens of criminal convictions and totaling tens of billions of dollars in criminal penalties is well-established,” Baker said. “No one should be surprised with their behavior in this study.”
Berenson suggested Pfizer may face difficulty getting the U.S. Food and Drug Administration (FDA) to approve its mRNA flu shot.
“These results are so bad that it is not clear whether the [FDA] could or would possibly approve an mRNA shot based on this data,” Benenson wrote. If it did, the vaccine’s commercial prospects “would be effectively nil.”
“This new failure may effectively end development of mRNA shots for respiratory viruses — and many other viruses too,” Benenson wrote.
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In a memo leaked last week, Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said changes are coming to the framework under which flu vaccines are evaluated.
“We will revise the annual flu vaccine framework, which is an evidence-based
catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine
effectiveness measured in case-control studies with poor methods. We will re-
appraise safety and be honest in vaccine labels,” Prasad wrote.
In August, the U.S. Department of Health and Human Services canceled nearly $500 million in funding for mRNA vaccine research.
Endpoints News reported last month that public demand for flu vaccines is stalling and that “the general consensus among vaccine makers for Covid-19, flu and RSV is that dampening demand has shrunk sales.” Data from Eurostat indicate a decline in flu vaccine uptake in the European Union.
Related articles in The Defender
- Pfizer Touts Success of mRNA Flu Vaccine Trial — Critics Push Back Citing Flaws, Gaps and Safety Signals
- ‘Vaccine Fatigue’? Merck Bets $9.2 Billion on ‘Not-a-Vaccine’ Flu Drug
- ‘Step in the Right Direction’: RFK Jr. Cancels $500 Million in mRNA Vaccine Contracts
- Moderna Pulls Application for FDA Approval of Flu-COVID Shot After FDA Calls for New Clinical Trials
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