Few moments crystallise the tension between profit-driven innovation and public health accountability like Pfizer's recent Phase 3 trial for its mRNA-based influenza vaccine (PF-07252220). Touted as a next-generation leap from the COVID-era mRNA playbook, the shot promised superior protection against seasonal flu strains. Yet, as results trickled out in late 2025, first in a glossy New England Journal of Medicine (NEJM) paper focusing on younger adults, then buried deep in ClinicalTrials.gov, the narrative unravelled. What emerged wasn't triumph but a stark safety fizzle: elevated risks of kidney failure, respiratory collapse, and all-cause mortality in the elderly, the very group flu hits hardest. From a vaccine-critical lens, this isn't mere scientific hiccup; it's a damning indictment of mRNA technology's unchecked hubris, regulatory capture, and the human cost of suppressing inconvenient truths.
The Trial's Two Faces: Selective Spotlight on the Young
Pfizer's C4781004 trial enrolled nearly 45,000 participants, with a staggering 60%, over 27,000, aged 65 or older, reflecting the demographic most vulnerable to flu's ravages (hospitalisation rates up to 10 times higher than in younger adults, per CDC data). The NEJM publication on November 19, 2025, zeroed in on the 18-64 cohort, where the mRNA shot eked out a relative efficacy of 34.5% over Sanofi's Fluzone comparator, modest at best, given flu vaccines' historical variability (19-60% effectiveness). Pfizer hailed it as "statistically superior," but critics like investigative journalist Alex Berenson noted the absolute risk reduction was a paltry 0.32%, meaning you'd need to jab 300 people to avert one mild case. More reactogenicity (side effects like fatigue and injection-site pain) plagued the mRNA arm, echoing COVID vaccine profiles.
The elderly data? Crickets in NEJM. A perfunctory nod in an accompanying editorial dismissed it, claiming no "safety concerns" in the young, while ignoring the high-risk cohort entirely. This wasn't oversight; it was strategy. As Daniel O'Connor of TrialSite News put it, omitting a "full high-risk cohort" from a top-tier journal reeks of "strategic de-emphasis of negative findings." Pfizer quietly dumped the results on ClinicalTrials.gov in May 2025, over a year late and without fanfare, breaching a 2023 promise to investors for end-of-year disclosure. In vaccine-critical circles, this selective transparency isn't science, it's spin, prioritising stock tickers over senior citizens.
Safety Signals That Scream: Kidneys, Lungs, and a Mortality Bump
Peel back the PR veneer, and the elderly arm's data paints a chilling picture. Compared to Fluzone, Pfizer's mRNA shot correlated with:
| Adverse Event Category | mRNA Group (n ≈ 13,500) | Comparator Group (n ≈ 13,500) | Relative Increase |
| All-Cause Mortality | 49 deaths | 46 deaths | +7% |
| Serious Adverse Events | 318 cases | 296 cases | +8% |
| Non-Serious Adverse Events | 3,091 cases | 1,720 cases | +80% |
| Acute Kidney Injuries | 16 cases | 7 cases | +129% |
| Acute Respiratory Failures | 17 cases | 6 cases | +184% (statistically significant) |
These aren't rounding errors. Karl Jablonowski, Ph.D., of Children's Health Defense, flagged the kidney and respiratory spikes as "astounding," with the latter showing a 185% heightened risk, enough to demand halting trials under any rigorous standard. Overall, 22 elderly participants suffered acute kidney injury, chronic kidney disease, or end-stage renal failure post-mRNA (vs. 9 on Fluzone), a "significant safety signal" per Berenson. Even cancer rates ticked up slightly (0.33% vs. 0.27%), aligning with emerging studies linking mRNA platforms to oncogenesis risks, like those from South Korea and Italy.
Pharmacologist Maria Gutschi called the kidney cluster a "big red flag," especially in "healthy retirees" screened to exclude comorbidities, meaning these weren't frail outliers but baseline users. Dr. Clayton Baker, an internal medicine specialist, quipped: "Who would want to take that mRNA shot over the conventional one? Nobody." Epidemiologist M. Nathaniel Mead, Ph.D., framed it as a "PR win" for Pfizer at the expense of transparency, warning that enrolling elders risks exposing "embarrassingly low or rapidly waning efficacy, plus higher rates of side effects or even paradoxical harm."
From a vaccine-critical standpoint, this isn't coincidence. mRNA's lipid nanoparticles (LNPs), the delivery vehicles,emerge as prime suspects. Gutschi's analysis posits LNPs as the toxicity culprits, independent of spike proteins (absent in flu shots), driving systemic inflammation and nephrotoxicity. French scientist Helene Banoun, Ph.D., highlighted Pfizer's opacity on dosing: elders got a higher microgram load than the 30μg for under-65s, yet the exact amount remains "hidden" in protocols. No placebo arm? That's by design, comparing to an existing (flawed) vaccine masks absolute risks, a tactic honed during COVID rollouts.
The Broader mRNA Reckoning: From COVID to Flu, the Cracks Widen
This fizzle isn't isolated. mRNA's post-COVID glow has dimmed amid "vaccine fatigue": Eurostat data shows EU flu uptake declining, while Endpoints News reports stalling demand shrinking sales for COVID, flu, and RSV shots. Moderna's combo flu-COVID application? Withdrawn after FDA demanded fresh trials. And now, under HHS Secretary Robert F. Kennedy Jr., the axe fell: In August 2025, nearly $500 million in mRNA research funding was axed, redirecting to "safer, broader platforms" like whole-virus vaccines. Kennedy cited mRNA's "more risk than benefits" for respiratory viruses, accusing it of driving mutations and prolonging pandemics, a politically charged pivot, but one echoing trial failures like this.
Enter FDA's Vinay Prasad, whose leaked November 2025 memo signals seismic shifts: Overhauling the "evidence-based catastrophe" of annual flu approvals, demanding honest labels, and scrutinising surrogates like antibody titers over real-world outcomes. Prasad's push stems partly from reanalysing COVID data, linking 10 child deaths to myocarditis, but extends to flu, mandating subgroup inclusion (e.g., pregnant women) and proof of infection reduction, not just immunogenicity. Critics like Paul Offit decry it as overreach, but we vaccine sceptics see vindication: Finally, regulators admitting the emperor's platform has no clothes.
Pfizer's history, decades of fraud convictions totalling billions, fuels the fire. As Baker noted, "No one should be surprised." Concealing elderly data? O'Connor warns of criminal liability if intent to deceive is proven, especially with foreseeable harms to a marketed demographic (69.7% flu vax coverage in U.S. elders). Retsef Levi, a CDC advisor, told journalist Maryanne Demasi the omission "calls into question the integrity of the clinical trial system." In a post-RFK era, FDA approval looks dicey; Berenson predicts "effectively nil" commercial prospects, potentially euthanising mRNA for respiratory bugs.
Time for a Vaccine Reset
Vaccine-critical voices, from Gutschi's "tell" of LNP-driven inflammation to Fouché's blunt "ineffective and causes even more deaths," have long warned mRNA's speed comes at safety's expense. This trial validates it: A technology rushed from lab to arm during COVID now falters in flu's slower burn, exposing harms in the overlooked elderly. Pfizer's fizzle isn't just a dud shot; it's a referendum on trusting profit-hungry giants with our most vulnerable.
The path forward? Demand unredacted data, placebo-controlled trials, and independent audits. HHS's funding cull and FDA's framework rewrite are steps, but true reckoning requires dethroning surrogates for endpoints that matter: lives saved, not antibodies conjured. As polls show eroding trust, 80% of Americans deeming PC culture (including vaccine orthodoxy) overreach, we're not just questioning one jab. We're auditing an entire paradigm. Pfizer's flu flop? It's the spark. Will regulators fan the flames of reform, or let Big Pharma bury the ashes?