Tag: influenza

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.”

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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

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Cleveland Clinic Flu Shots Study Shows Vaccine INCREASED Risk of Getting the Flu

For decades, Americans have been lectured, pressured, and in many cases coerced into getting annual flu shots under the promise that “the science is settled” and that vaccination is an unquestionable public good.

But a growing body of research is blowing that narrative apart, and the latest data are nothing short of explosive.

A new study from the prestigious Cleveland Clinic has found that the 2024-2025 flu shot not only failed to protect people but also increased their risk of contracting the flu.

The study, published as a preprint on medRxiv and led by Dr. Nabin K. Shrestha and colleagues from the Departments of Infectious Diseases, Infection Prevention, and Quantitative Health Sciences, tracked 53,402 Cleveland Clinic employees across Ohio during the 2024–2025 respiratory viral season, which began on October 1, 2024.

By the end of the 25-week observation period (ending March 26, 2025), 82.1% of the cohort (43,857 individuals) had been vaccinated, primarily with the trivalent inactivated vaccine.

A total of 1,079 employees (2.02%) tested positive for influenza, with 98.8% being influenza A cases.

Using a time-dependent analysis (treating vaccination as a variable that changes over time), the researchers calculated a vaccine effectiveness of -26.9% (95% CI: -51.0% to -6.6%). This means vaccinated individuals had a 27% higher hazard ratio (HR 1.27) for contracting influenza compared to unvaccinated ones, after adjusting for factors like age, sex, job type (e.g., clinical nursing), and work location.

The study addressed potential biases by examining testing rates. Vaccinated employees were more likely to get tested, but the proportion of positive tests was similar between groups, suggesting the higher infection rate wasn’t due to testing differences but actual increased susceptibility.

A Simon-Makuch plot showed that early in the season, infection rates were similar, but they rose more rapidly among the vaccinated over time.

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Experts agree: There is no such thing as “Super Flu”.

Currently, the headlines all across the United Kingdom, and a handful of other nations, are full of references to “Super Flu”.

There is no such thing as “Super Flu”.

It is a term with no scientific meaning or even a solid definition. To confirm this we need look no further than this report from Channel 4 News:

NHS England is calling it a ‘super flu’, which is in fact its own phrase rather than anything scientific.

Or, even more tellingly, there is Devi Shridhar — the High Priestess of Covid hysteria herself — whose Guardian column is headlined “Don’t Call it the Super Flu”, and begins:

I should start by saying “super flu” is not a scientific term or one used by any academics or clinicians I work with. It’s a colloquial phrase that’s been used by various NHS England bosses and taken up by Wes Streeting, the health secretary, and Keir Starmer.

That’s that then. The experts have spoken: “Super Flu” is a colloquial phrase with no actual meaning.

So why does everyone keep describing the incipient flu season in those terms?

To quote Shridar again:

Amid all the noise, it’s difficult to know how bad this flu really is – and how much is political spin.

Isn’t it just?

Maybe it’s time we found out how bad this flu really is, and what about it (if anything) is “super”.

First, we should ask: Doe this flu have different symptoms? Or are the symptoms more severe?

It doesn’t, and they are not, as Dr Giuseppe Aragona tells the Independent [emphasis added]:

The symptoms and severity of H3N2 illness have been similar to seasonal flu, including fever, cough, runny nose, and possibly other symptoms, such as body aches, vomiting, or diarrhoea.

Ok, so its symptoms are common and not unusually severe. Then maybe it’s more transmissible? Or deadly?

Nope. At least, not according to the WHO experts quoted in Politico [emphasis added]:

While hospital admissions have been rising sharply due to the early arrival of flu season, there is currently no evidence that this season’s variant is more deadly or transmissible, experts at the World Health Organization (WHO) and the European Centre for Disease Prevention and Control (ECDC) told POLITICO.

OK, let’s sum up what we know so far:

  • This flu has no unusual symptoms.
  • Its symptoms are not unusually severe.
  • It is not any more transmissible than normal.
  • It is no more deadly than normal.

It seems there is nothing even odd about this flu, let alone “super”.

A lot of the news coverage is focusing on the potential danger to the NHS, with headlines warning this is “beyond catastrophic” and “pushing the NHS to the brink”.

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Face masks made compulsory at some UK hospitals amid flu surge

Compulsory face masks are being implemented in some UK hospitals due to escalating flu levels. Good Morning Britain announced the changes following an NHS chief’s plea for anyone exhibiting symptoms to don a mask in public.

Kate Garraway, presenter on the ITV show, stated this morning: “Four hospitals in England have declared critical incidents as a result of the record-breaking flu admissions. Face masks have also been made compulsory at some sites.”

Daniel Elkeles, chief executive of NHS Providers which represents NHS trusts, said earlier this week that the country is experiencing a “very nasty strain of flu” that has emerged earlier in the year than usual. He advised: “”When you were talking about anything like Covid, I think we need to get back into the habit that if you are coughing and sneezing, but you’re not unwell enough to not go to work, then you must wear a mask when you’re in public spaces, including on public transport to stop the chances of you giving your virus to somebody else.”

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Pfizer buries data showing mRNA flu vaccine bombed in trial with elderly, not much better under 65

wo years ago, Pfizer anticipated that sales of its rebound-prone COVID-19 oral antiviral Paxlovid and fully approved mRNA COVID vaccine Comirnaty would plummet, but good news appeared on the horizon: The drugmaker’s mRNA flu vaccine did well in phase 3 trials in ages 18-64, and Pfizer expected to release results from the 65-and-up cohort “later this year.”

The results are finally in: Compared to a standard flu shot, the mRNA vaccine was associated with six times as many adverse events as infections prevented in adults under 65, and it outright failed in elderly people, associated with more deaths and both minor and serious injuries, from injection-site swelling to kidney problems.

The company buried the long-delayed elderly results on the government’s clinical trials website this spring, more than a year late and without announcing them to the public or investors, and gave an optimistic take on the under-65 results in the New England Journal of Medicine last week, while admitting the mRNA shot was “associated with more reactogenicity events.”

Australian and American drug industry journalists dug into the two arms of the trial, predicting mRNA jabs for flu would face an uphill climb with Trump administration regulators, who have already canceled nearly $500 million in federal projects and contracts that went toward mRNA vaccine development.

Pfizer used the same testing structure for mRNA flu shots as for its COVID shots and still found only an absolute difference of 0.32% for under-65s, requiring vaccination by 300 people to “prevent a single mild, self-limiting illness,” physician-turned-investigative journalist Maryanne Demasi wrote in an X thread summarizing her deep-dive review.

“Put simply, it’s a manufacturer-funded trial, written largely by Pfizer employees & finds its best efficacy in the endpoint that requires all samples to be shipped to a Pfizer-run central lab for adjudication,” Demasi said.

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CDC, NIAID, DARPA Infect 36 People with Lab-Made Epidemic Influenza Virus: Journal ‘Influenza and Other Respiratory Viruses’

The U.S. military and Health and Human Services (HHS) have funded an experiment that infected 36 individuals with an epidemic influenza A/Wisconsin/67/2005 (H3N2) virus that was manufactured in a laboratory, according to a June study published in the peer-reviewed journal Influenza and Other Respiratory Viruses.

Congress, the White House, the Department of Energy, the FBI, and the CIA have confirmed that the COVID-19 pandemic was likely the result of lab-engineered pathogen manipulation.

But the government is not only engineering outbreak pathogens in the lab—they’re intentionally infecting people with them.

The influenza strain A/Wisconsin/67/2005 (H3N2) used in the new study is associated with several influenza epidemics, notably during the 2005-2006 and 2006-2007 seasons, reportedly causing widespread outbreaks.

The DARPA-funded experiment’s implications reach far beyond academic inquiry, raising grave national security concerns because lab-engineered viruses have the potential to ignite epidemics and pandemics if accidentally or deliberately released.

It also raises serious informed-consent questions, since participants who became contagious could have exposed others outside the study to a laboratory-created pathogen without their knowledge.

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National Guard “Accidentally” Gives Service Members COVID-19 Vaccine Instead of Influenza Shot

This week it was revealed that the US National Guard wrongly administered the Covid vaccine to a group of service members who were expecting to receive an influenza vaccine, according to The Epoch Times. The incident occurred during a mobile vaccination clinic for the Maine National Guard and at least one member who refused the mRNA vaccine on religious grounds received the experimental injection without his knowledge.

That service member, Mathew Bouchard, is no longer a member of the National Guard. After the incident, he felt that the trust was completely broken. He was ordered to take a flu shot and feels like he was duped. Because the incident happened close to the end of his service contract, he chose not to renew.

Bouchard explained his decision to The Epoch Times:

“Bouchard said he was ordered to receive an annual flu vaccine and went to the clinic to get that vaccine. He verified his name, date of birth, and part of his social security number, and told officials at the clinic he was there for the flu vaccine. But he was injected with a dose of a messenger RNA COVID-19 vaccine, officials told him.

‘You know how you went in for the flu shot? Well, that wasn’t a flu shot. That was a COVID-19 vaccine,’” Bouchard told The Epoch Times, recounting the meeting with superiors.

“I think, in my mind, at that point, it was like, I completely didn’t know if I trusted any people in the military,” he added.”

In addition to Bouchard, two other service members “were accidentally given a Covid vaccine” instead of a flu injection that day, Maine National Guard spokesperson Maj. Carl Lamb explained in an email to The Epoch Times. The clinic was administering both types of vaccine, which likely led to the egregious error.

“Accident” or not, the incident is inexcusable. Especially considering the recent data that has been revealed about the dangerous and deadly adverse reactions caused by the experimental mRNA vaccines – particularly among otherwise healthy young adults. Just this week, the surgeon general of Florida announced new guidelines about the vaccine that show the jab causes a stunning 84% increase in cardiac-related death among 18-39-year-old men. The state of Florida now officially recommends that young males refrain from receiving the mRNA vaccine completely.

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Pentagon Ends Flu Vaccine Mandate for Reservists, But Not Active Duty Troops

The Pentagon revised its flu vaccine policy for some, but not all, service members, according to a May 29 memo, first reported on today by The Associated Press.

Under the revised policy, reserve members, which include the National Guard, aren’t mandated to get the flu shot unless they are called to active duty for 30 consecutive days or more. If they choose to get the vaccine, the U.S. Department of War (formerly Department of Defense) won’t compensate them for their time and expense.

Active-duty service members are still required to get the vaccine.

According to the memo by U.S. Deputy Secretary of Defense Steve Feinberg:

“All Active Component Service members are required to receive the annual seasonal influenza immunization or obtain an exemption (i.e., medical or administrative). Reserve Component Service members activated for 30 consecutive days or more are required to receive the seasonal influenza immunization or obtain an exemption. During an outbreak, pandemic influenza immunizations will be required or recommended as appropriate, depending on the immunization’s regulatory status at the time of the outbreak.”

A Pentagon official today confirmed that they changed the policy, telling The Defender:

“On May 29, 2025, the Department released updated policy guidance on seasonal influenza immunizations, reflecting common-sense revisions to existing requirements.

“There are no changes to policy for active-duty Service members, who are still required to receive the annual flu vaccine. Likewise, requirements for civilian employees will continue to be based on occupational risk for contagion and spread. For example, all healthcare workers are required to receive the flu vaccine.”

U.S. Secretary of Defense Pete Hegseth drew attention to the May memo on Wednesday when he retweeted a celebratory post from a National Guard member who said, “I found out today that for the first time in over a decade, I won’t be forced to get a flu shot this fall for the privilege of serving my state and country.”

Military flight surgeon Lt. Col. Theresa Long told The Defender that service members are still trying to get clear information about the COVID-19 vaccine and the full implications of its impact on the health of service members.

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Gates-Funded Study Confirms 27% Higher Risk of Heart Injury in Influenza-Vaccinated Compared to Unvaccinated: ‘The Lancet’

A massive new study funded in part by the Bill & Melinda Gates Foundation and published last week in The Lancet’s eClinicalMedicine provides evidence that seniors vaccinated for influenza experienced more heart injuries, not fewer.

The findings come after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. cut American funding to Bill Gates’ vaccine syndicate Gavi, citing a 2017 study showing the DTP shot “may kill more children from other causes than it saves” from diphtheria, tetanus, or pertussis.

The new influenza vaccine study analyzed over 8.1 million Chinese adults aged 65 and older between 2020 and 2022.

Out of those, just 170,011 received an influenza vaccine, while more than 8 million remained unvaccinated.

Researchers then tracked the rate of major cardiovascular events in each group.

The Raw Data Tell the Story

The most striking finding comes from the crude numbers.

When researchers looked at acute coronary syndromes (ACS)—a category that includes heart attacks, unstable angina, and other sudden cardiac events—the results were blunt:

  • Vaccinated: 26.4 events per 1,000 person-years
  • Unvaccinated: 26.3 events per 1,000 person-years
  • Crude incidence rate ratio (IRR): 1.27 (95% CI: 1.24–1.31)

That figure means vaccinated seniors had a 27% higher risk of heart injury compared to the unvaccinated.

This is the kind of red-flag signal that would normally demand urgent investigation. Instead, the authors buried it under layers of statistical adjustments.

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