Tag: influenza

Moderna’s mRNA Flu Vaccine Gets Unanimous Thumbs-Up Despite Risks, Low Efficacy

A federal advisory committee today unanimously voted to endorse Moderna’s mRNA flu vaccine — just months after rejecting the company’s application on the basis that Moderna had not performed an “adequate and well-controlled” clinical trial.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews scientific data on the safety and effectiveness of vaccines and other therapeutics on behalf of the U.S. Food and Drug Administration (FDA), voted 9-0 in dual votes to recommend approval of the vaccine for the 50-64 and 65-plus age groups.

Today’s votes took place after several hours of presentations based on the findings of Moderna’s Phase 4 clinical trial data for its mRNA-1010 vaccine. The trial compared the efficacy of mRNA-1010 to that of a conventional, non-mRNA flu vaccine.

Daniel O’Connor, founder and CEO of TrialSite News, told The Defender today’s favorable votes “may reflect the committee’s view that the benefit-risk profile is acceptable.” However, the vote “does not erase the fundamental concerns surrounding this application.”

“Significant questions remain about comparator selection, study design and whether the reported efficacy advantage represents a clinically meaningful improvement for patients or simply a statistical advantage within the framework of the trial,” O’Connor said.

According to an FDA briefing document prepared in advance of today’s meeting, “no major deficiencies were identified” with the vaccine for adults 50 and over. Citing the clinical trial data, the document states that the mRNA-1010 vaccine had a 26.6% relative efficacy rate in adults 50 and over, with similar rates for adults 65 and up.

The mRNA-1010 vaccine also showed a higher immune response than Sanofi’s Fluzone vaccine, the document noted. According to Fierce Biotech, these results met all of the FDA’s “pre-specified criteria for success” and bolstered Moderna’s application for approval.

Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said today’s vote shifts mRNA-1010 safety monitoring to after licensure.

“VRBPAC meetings proceed to the beat of the rubber stamp. The unanimous vote guarantees a lot of really good questions of harm will have to be answered in the post-marketing period, when that harm manifests in the population,” Jablonowski said.

Moderna seeks traditional approval for the mRNA-1010 vaccine for the 50-64 age group and accelerated approval for the 65-plus age group.

Fierce Biotech reported that the FDA uses VRBPAC meetings to “seek outside counsel on tough or high-profile regulatory decisions.”

The FDA will make an approval decision on mRNA-1010 by Aug. 5 — and while the agency is not bound to VRBPAC’s votes, it “often follows the opinions” of its advisory committees.

Moderna’s stock was up over 4% in trading immediately after the vote, and up 3.50% at the close of market.

mRNA vaccine had higher rate of adverse events than conventional flu shot

Keep reading

The great FLU ILLUSION: Bombshell study proves transmission is a myth and PCR tests are junk science

Virology misunderstood

If the flu virus is as contagious as we have been told, transmission should have been rampant. It was not. Only one recipient out of 75 became infected. That is a 1.3% secondary attack rate. The researchers expected at least 16%. They missed their target by more than tenfold.

To shed further doubt on virus transmission and the common measures used to protect against viral shedding, the study divided recipients into two groups. The intervention group wore face shields and sanitized their hands every 15 minutes. The control group did neither. The result? Zero infections in the intervention group and one infection in the control group. Statistically, there was no difference between the groups. This finding renders the entire mask debate moot. If face shields and constant hand sanitizer cannot stop transmission when both groups fail to get infected anyway, what exactly are we protecting ourselves from?

Virus transmission appears to be an imaginary concept, driven by fear and hysteria.

The uncomfortable truth about viral shedding

Now, forty-two of the 52 donors who were deliberately infected actually became infected after inoculation. That is an 81% infection rate through direct inoculation. And they shed virus from their noses in substantial quantities. Their viral loads were high enough to register on PCR tests with cycle threshold values in the mid-20s. Yet, remarkably, they did not pass the virus to the people sitting next to them. The researchers also measured the exhaled breath of donors using a device called the Gesundheit-II. They found that only 11 out of 42 infected donors had detectable virus in their breath aerosols. Even then, the quantities were two to four logs lower than what has been observed in naturally infected people who were selected for having fever and high viral loads.

This raises an obvious question. If the virus is so hard to transmit in a controlled setting where infected people are breathing directly onto susceptible people for days, how does it ever spread in the real world? The researchers tried to explain their failure by pointing to the building ventilation system. The proof-of-concept study was conducted in a hotel room with recirculating air, and it did have a higher transmission rate. The follow-on study used mechanical ventilation that diluted the air. They concluded that aerosols might be important after all. But this explanation is circular. If transmission depends on airtight rooms with no fresh air, then the virus is not a robust airborne pathogen. It is a fragile entity that requires extreme conditions to move from one person to another.

The fallacy of the contagious patient

The study also revealed something that should make every public health official reconsider their assumptions. Many of the directly infected donors did not get sick. Ten out of 42 infected donors were classified as asymptomatic. They had the virus in their bodies; it was confirmed through PCR; they shed it from their noses, but they felt fine. No fever, no cough, no runny nose. Yet they were placed in rooms with susceptible people and still did not transmit. The researchers admitted that their model produced donors who were “minimally contagious.” But if a person with a laboratory-confirmed infection who is breathing on you for 15 hours a day cannot make you sick, what does that say about the millions of asymptomatic cases that were used to justify lockdowns, school closures, and mask mandates?

The collective pandemic protection measures were not based on science; they were only used to control people, weaponizing their virtue and their fear.

Keep reading

Despite Over 100 Deaths in Moderna’s mRNA Flu Trial – Committee Recommends that the FDA Move Forward with Approval

June 18, 2026: Moderna just announced that, “the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010, Moderna’s investigational seasonal influenza vaccine, outweigh its risks for the prevention of influenza disease in adults 50 through 64 years of age and in adults 65 years of age and older.”

This is despite the fact that Moderna reported 102 deaths in the mRNA group and 97 deaths in the ‘enhanced vaccine’ group.

102 reported deaths out of 35,965 mRNA injected study participants equate to a 0.3% fatal adverse event (death) rate in less than a year of being injected.

Adults aged 50-64 have a 0.015% of dying from the flu vs. 0.3% from a flu injection = a 20-fold (1900%) increase).

Adults 65 and older have a 0.05% chance of dying from the flu vs 0.3% from a flu injection = 6-fold (500%) increase.

Keep reading

Study Finds Pediatric Flu Shots are a COMPLETE FAILURE

A new peer-reviewed study evaluating the rollout of mass pediatric flu vaccination across an entire Spanish health region (~400,000 people) found NO statistically significant reduction in flu cases or hospitalizations after authorities expanded flu shots to children 6 months to 5 years old.

Researchers analyzed 6,804 primary care influenza diagnoses and 3,252 influenza-related hospitalizations between 2018 and 2025, comparing seasons before and after the pediatric flu shot program began in 2023.

Despite the rollout, the study’s more rigorous interrupted time series analysis found no measurable reduction in influenza diagnoses or hospital admissions among the target age groups (0–2 and 2–4 years).

In plain English: the flu shots did not meaningfully lower flu rates in young children. Kids under 5 were no less likely to show up at the doctor with the flu or end up hospitalized than expected after the rollout. In other words, the program failed to produce a measurable real-world benefit in the exact age group it was designed to protect.

Notably, researchers also looked across all age groups in the region to see whether vaccinating young children indirectly protected the broader community. Again, they found no statistically significant reduction in flu-related hospitalizations or meaningful population-level benefit following rollout.

The study ultimately concluded that routine pediatric influenza vaccination “has not been associated with a reduction in influenza cases in primary care or hospital settings.”

These results are not surprising given that the Cleveland Clinic recently found that flu shots were associated with a 27% higher risk of flu among healthcare workers during the 2024–2025 season.

Keep reading

91% of Flu Vaccine Recipients Shed Chimeric Lab-Made Vaccine Virus, Raising Transmission Concerns: NIH-Funded Journal ‘Clinical Infectious Diseases’ Study

A newly published, U.S. government-funded, peer-reviewed study has confirmed that a live attenuated influenza vaccine caused detectable post-vaccination viral shedding in more than 91% of adult recipients, raising major questions about whether vaccinated individuals function as carriers and spreaders of vaccine-derived influenza pathogens after immunization.

The findings, published Thursday in the journal Clinical Infectious Diseases, claim that the purported virus inside the vaccine actively replicated inside recipients after administration and was subsequently shed from the nose in the overwhelming majority of participants.

Researchers from George Washington University evaluated 283 healthy adults between the ages of 18 and 49 who received the intranasal live attenuated influenza vaccine (LAIV), FluMist, during the 2023–2024 and 2024–2025 flu seasons.

The new paper explicitly states:

“LAIV replication begins within 24 hours and declines over the first week…”

Researchers further explained that the virus in the vaccine:

“replicates in the upper respiratory tract, mimicking a natural infection…”

In plain English, the vaccine virus reproduces inside recipients and is expelled back out through the nose afterward.

Researchers collected nasal swabs on day 1, days 2–4, and days 5–7 after vaccination and measured influenza A and B RNA using RT-PCR testing.

Keep reading

Air National Guardsman Being Denied Reenlistment for Refusing Flu Shot Cites Violation of Constitutional Rights

After 18 years of dedicated service, Arkansas Air National Guardsman Chris Babczak is being denied the opportunity to reenlist next month—solely because he stood firm in his decision to refuse the flu vaccine [emphasis mine].

It is important to highlight that this will happen two years before reaching retirement eligibility. Additionally, it should be noted that this is taking place under the current leadership. Moreover, as these individuals should be ready to acknowledge at this point, scientific evidence suggests that receiving an annual flu shot may actually heighten the risk of contracting influenza.

The Gateway Pundit spoke to Technical Sergeant Chris Babczak who shared that he was able to opt out of the COVID-19 vaccine, in 2022, due to his involvement in a class action lawsuit with fellow objectors. After researching the effectiveness and risks associated with the COVID-19 shot, the C-130 aircraft electrician also submitted a request for a religious accommodation regarding the flu vaccine. “Like COVID,” he said, “it was a rubber stamp denial.”

In the years to follow, Babczak has taken it upon himself to learn the law and know his rights, stating that “never again will I ask permission for any of my rights when government agencies, to include the military, never had constitutional authority to interfere with conscience beliefs or to make health decisions for people in the first place.”

He pointed to Article 2, section 24 of the Arkansas Constitution, which explicitly states, “No human authority can, in any case or manner whatsoever, control or interfere with the right of conscience.”

He further contended that “offering religious accommodations converts a right into a privilege and gives a false presumption that government, or the military in my case, can make a person’s health decisions by requiring a vaccine, even when a person lawfully objects.”

For him, “A person’s right to health is an absolute right, the constitution secures the right to health against government compulsion of a vaccine.”

Keep reading

Why your flu shot may work differently than you think

Two decades of federal surveillance data reveal how immune imprinting and an aging immune system undermine flu vaccine effectiveness. Current universal vaccination policy has not caught up to the biology.

Every autumn, public health authorities deliver a message that is simultaneously accurate and misleading: get your flu shot. All Americans aged six months and older are recommended to receive one. The guidance is consistent, reassuring, and considerably more complicated than it sounds.

A synthesis of two decades of CDC surveillance data, which will be published separately in Malone.News makes an argument that has been quietly building in the immunology literature for years: the current one-size-fits-all approach to seasonal influenza vaccination fails to account for two fundamental features of how the immune system actually works. The first is that your first flu exposure as a child permanently shapes how you respond to every flu vaccine you will ever receive. The second is that the immune system ages in ways that make older adults both the most important target for vaccination and the least reliable responders to it.

This is not a case against flu vaccination. It is a case for being honest about what the vaccine does and does not do, and for whom. In other words, it is a case for open and transparent informed consent.

Keep reading

Influenza Vaccine Effectiveness Lower In Recent Months, Preliminary Data Show

The effectiveness of vaccines against influenza dropped during the 2025–2026 virus season, officials said on March 12, about two months after the Centers for Disease Control and Prevention (CDC) stopped recommending flu vaccination for all children.

Vaccine effectiveness for late 2025 and early 2026 against outpatient visits and hospitalization was pegged at 14 percent to 48 percent among children, Dr. Lisa Grohskopf, with the CDC’s Influenza Division, said at a meeting hosted by the Food and Drug Administration (FDA).

The shielding among adults was just 22 percent to 34 percent, she said, based on data from CDC networks in 16 states.

Influenza vaccine effectiveness since 2009 has dropped as low as 19 percent and risen as high as 60 percent. It was 56 percent in late 2024 and early 2025, according to the CDC.

Grohskopf said the reasons for the decline from the prior season are not yet clear. Factors could include that fewer people received vaccines and a mismatch between strains in the vaccines and the strains that ended up circulating.

Most influenza cases in recent months have been caused by influenza A viruses, particularly an H3N2 subvariant called subclade K.

Grohskopf said the data are preliminary and could end up changing.

William Gruner, representing Department of War scientists, said at the same meeting that vaccine effectiveness among department networks against influenza-like illness from Nov. 9, 2025, through Feb. 21, 2026, was 32 percent among children and 46 percent among adults.

“Still a lot more data to be collected this season, so things can certainly change,” Gruner said.

They presented to the FDA’s Vaccines and Related Biological Products Advisory Committee during the largely virtual meeting.

Dr. Hayley Gans, a committee member, said she was concerned that the estimates were inaccurate.

“I think this data doesn’t support at least for what we see in pediatrics,” she told Grohskopf.

Keep reading

Moderna threatens American jobs after FDA snubs mRNA flu shot, trial looked ‘scientifically lax’

For years before he became director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, epidemiologist Vinay Prasad openly railed against what he perceived as the shoddy design of drug trials and the deference regulators gave them, sending biotech stocks tumbling when Commissioner Marty Makary appointed him.

A vaccine maker that hit the federal jackpot during COVID-19 acted caught off-guard when the former University of California San Francisco medical professor put his gripes into practice, halting its FDA application for a new mRNA flu vaccine based on what he considered weak trial design.

Moderna accused Prasad, who described his predecessor Peter Marks as a “bobblehead” for drug approval, of changing the rules in the middle of the game by refusing to review its biologics license application (BLA) without citing “specific safety or efficacy concerns.”

Prasad’s Feb. 3 “refusal to file” letter – which Moderna posted a week later on its COVID resources page for some reason – says the FDA warned the company before it even started the mRNA flu trial that the proposed design raised red flags.

“CBER does not consider the application to contain a trial ‘adequate and well-controlled’ and the application is therefore, on its’ [sic] face, inadequate for review,” because the control arm “does not reflect the best-available standard of care in the United States at the time of the study,” Prasad said, which was “consistent with FDA’s advice” before the study.

This was just the agency’s “preliminary review of the application and is not indicative of deficiencies that would be identified later,” when the FDA conducts a “substantive review,” Prasad emphasized, implying fresh hurdles for Moderna even if it runs a new trial.

Moderna CEO Stéphane Bancel responded with his own thinly veiled threat against Prasad, who had already left the administration once under assault from populist and corporate conservatives who blasted his avowed support for progressive policies and more regulation before Prasad joined the administration. 

CBER’s decision, which Bancel reiterated “did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” said the billionaire Frenchman, who came to Boston-based Moderna from French diagnostics company BioMerieux.

“We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” Bancel said, hinting the company would take jobs overseas if the FDA continued its current trajectory.

Department of Health and Human Services spokesperson Andrew Nixon told Just the News Moderna ignored “very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”

Keep reading

FDA Requires Vaccine Makers to Include Febrile Seizure Warning on Flu Shot Labels

The U.S. Food and Drug Administration (FDA) notified six influenza vaccine manufacturers on Jan. 9, 2026 that they must add a warning about the risk of febrile (fever) seizures to their product information labels, citing newly identified postmarketing safety data. The notices, issued under the FDA’s statutory authority to mandate safety labeling changes, were sent to Sanofi, AstraZeneca, GlaxoSmithKline (GSK), and CSL Seqirus.1

According to the FDA, observational analyses conducted during the 2023–2024 and 2024–2025 influenza seasons identified a statistically significant increase in seizures caused by fevers occurring within one day of vaccination among children aged six months through four years, prompting the agency to conclude the findings constitute “new safety information” requiring disclosure in product labeling. In its notification letter, the FDA stated that the results of the analyses “suggest a causal relationship”—language the agency typically avoids unless compelled by evidence.2

The data suggested an “estimated attributable risk of 21.2 excess febrile seizure episodes per million standard-dose quadrivalent influenza vaccinations” and “an attributable risk of 44.2 excess febrile seizure episodes per million standard doses of trivalent [influenza] vaccinations.”

Risk of Febrile Seizures May Increase After Childhood Vaccinations

The Mayo Clinic website states that in some infants and young children fevers can cause convulsions (seizures). Doctors generally describe “simple” febrile seizures as associated with fevers over 100 F, short-lived and typically harmless, although “complex” febrile seizures can last longer than 15 minutes and occur more than once in a 24-hour period.3

It has been acknowledged in the medical literature that convulsions can include an increased risk of future epilepsy (uncontrolled seizure disorder).4 5 Febrile seizures have also been associated with a spectrum of brain dysfunction and rarely, severe brain injury or death.6 7

Bioengineer Brian Hooker, PhD said he disagrees with febrile seizures being characterized as harmless. He said:

Any seizure is bad, period. Mild’ febrile seizures can double a child’s chance of an epilepsy diagnosis and ‘complex’ febrile seizures—lasting more than 15 minutes —can increase that risk up to 10 times.8

On the topic of febrile seizures and childhood vaccines, Mayo Clinic states:

The risk of febrile seizures may increase after some childhood vaccinations. These include the diphtheria, tetanus and pertussis vaccine and the measles-mumps-rubella vaccine. A child can develop a low-grade fever after a vaccination. The fever, not the vaccine, causes the seizure.9

The U.S. Centers for Disease Control and Prevention (CDC) acknowledges that some vaccines are associated with a higher risk of febrile seizures than others, particularly in infants and young children, and that the risk increases when certain vaccines—such as the influenza, pneumococcal (PCV13), and DTaP vaccines—are administered during the same visit.

The agency also notes that measles-containing vaccines, especially the MMRV (measles, mumps, rubella, and varicella) combination, are associated with a higher risk of febrile seizures than their single-component counterparts, and that these events tend to occur within specific post-vaccination time windows. Still, CDC guidance emphasizes that the overall risk is small, that febrile seizures are typically short-lived and without lasting harm, and that vaccination should continue according to the recommended schedule.10

Keep reading