Tag: fda

FDA Approves Moderna’s mRNA Flu Vaccine for Adults 50 and Older

FDA Approves Moderna’s mRNA Flu Vaccine for Adults 50 and Older

The U.S. Food and Drug Administration approved Moderna’s mRNA influenza vaccine, mFLUSIVA, for adults aged 50 and older, marking the first time the agency has licensed an mRNA vaccine for seasonal influenza, according to a company statement reported by The Epoch Times [1]. Moderna said the FDA granted traditional approval for adults aged 50 to 64 and accelerated approval for adults 65 and older.

The approval followed a unanimous 9-0 recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee [2]. The FDA had initially declined to review the application over concerns about trial design before reversing course after a high-priority meeting, according to a report by NaturalNews.com [3]. Moderna CEO Stéphane Bancel called the approval “our fourth approved product in the United States and the first mRNA-based flu vaccine” [4].

Approval Conditions and Trial Data

Moderna said the approval was based on a late-stage trial of more than 40,000 adults aged 50 and older that found the shot was 26.5 percent more effective than a licensed standard-dose flu vaccine. The company agreed to run an additional study and submit further data on adults 65 and older to demonstrate the vaccine’s benefit in that age group, and Moderna also submitted separate late-stage data showing stronger antibody responses than Sanofi’s high-dose flu vaccine in adults 65 and older after problems with the phase 3 trial methodology, according to The Epoch Times [1].

The vaccine uses mRNA technology intended to prompt the body to produce influenza antigens and trigger an immune response. Scientists said the approach could allow faster updates of the shot to match circulating strains [1]. In a 92-page review document, FDA reviewers said the trial’s use of a standard-dose comparator limited interpretation of clinical benefit for adults 65 and older. “This limitation affects interpretation of the net clinical benefit in the 65 and older population and is a key issue for Advisory Committee deliberation,” the reviewers wrote [1].

Adverse Events, FDA Review and Disclosures

The trial found higher rates of adverse events among mFLUSIVA recipients than among recipients of the comparator vaccine, with side effects including fatigue, headache, and muscle pain, according to FDA reviewers cited in The Epoch Times report. Serious adverse events occurred in 2.2 percent of mRNA vaccine recipients, with three events considered vaccine-related, compared with 1.9 percent in the comparator group [1].

A French peer-reviewed study published in 2022 concluded that mRNA COVID-19 shots increased the risk of myocarditis and pericarditis, particularly in adolescent and young adult males after a second dose, the report said [1]. The report also noted that multiple FDA advisory committee members who voted in favor of the flu vaccine had connections to Moderna, including El Sahly and Dr. Flor Munoz, who was a Moderna adviser from 2022 to 2024 [1].

Regulatory and Policy Context

Health Secretary Robert F. Kennedy Jr., who oversees the FDA, announced in August 2025 that the Department of Health and Human Services was winding down mRNA vaccine development under the Biomedical Advanced Research and Development Authority. Kennedy said funding would be redirected toward “safer, broader vaccine platforms that remain effective even as viruses mutate” [1]. In July 2026, HHS said Kennedy had signed determinations terminating the COVID-19 Emergency Use Authorization declarations for drugs, biological products, and medical devices [5].

Several FDA officials who had voiced opposition to mRNA vaccines have recently departed the agency, according to The Epoch Times [1]. An investigation by TrialSite News reported that regulators reviewing COVID-19 mRNA vaccines possessed data showing the products could travel throughout the body, even as the public was told the vaccines stayed “in the arm” and disappeared within a day or two [6]. Moderna withdrew its application for a COVID-flu combination shot last year after the FDA sought additional evidence, and European regulators approved the combination shot in April, the report said [1].

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FDA Reverses Course, Approves Moderna’s Experimental mRNA Flu Vaccine Months After Initial Rejection

The Food and Drug Administration (FDA) has approved Moderna’s experimental mRNA influenza vaccine, reversing an earlier decision that blocked the application over concerns about the company’s clinical trial design.

The approval marks a significant turnaround after regulators, under Health and Human Services Secretary Robert F. Kennedy Jr., initially refused to even review Moderna’s submission.

Officials at the time said that the company had failed to compare its vaccine against what officials considered the best available standard of care.

Back in February, FDA vaccine chief Dr. Vinay Prasad concluded that Moderna’s study was not “adequate and well-controlled” because it used GlaxoSmithKline’s Fluarix Quadrivalent vaccine as its comparator rather than a stronger-performing alternative.

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Sanofi Made False Claims About RSV Shot for Infants, FDA Says

In a letter to the drugmaker, the FDA said the agency approved Beyfortus, an RSV monoclonal antibody, as a defense against RSV lower respiratory tract disease — but that Sanofi has been claiming it protects broadly against RSV disease, which occurs in the lower and upper tracts. Beyfortus has come under scrutiny following reports of at least two infant deaths during clinical trials for the drug.

The U.S. Food and Drug Administration (FDA) is accusing Sanofi of making false or misleading promotional claims about Beyfortus, a preventative treatment for RSV, Fierce Pharma reported.

In a letter to the drugmaker, the FDA said it approved Beyfortus specifically as a defense against respiratory syncytial virus (RSV) lower respiratory tract disease — but that Sanofi has been claiming it protects broadly against RSV disease, which occurs in the lower and upper tracts.

The company has sent providers emails urging them to give the shot to “help prevent RSV disease in infants.”

The promotional materials included other similar statements, including, “Beyfortus is a monoclonal antibody that helps prevent RSV disease starting from Day 1 after injection,” and “Your efforts in immunizing infants against RSV disease can impact the population health burden in your community.”

The FDA said that language creates the “misleading impression” that the drug prevents RSV disease generally.

FDA asks Sanofi to take immediate action to stop misbranding RSV shot

Beyfortus, a monoclonal antibody manufactured by Sanofi and AstraZeneca, was approved by the FDA in 2023. Unlike a vaccine, monoclonal antibodies provide passive immunity by delivering laboratory-produced antibodies designed to protect infants against severe RSV disease.

The FDA emphasized that Beyfortus is specifically approved for the prevention of RSV lower respiratory tract disease — not RSV infection or upper respiratory tract illness generally.

The agency noted that while the promotional emails later referred to protecting infants from “RSV-LRTI,” lower respiratory tract infection,  that clarification did not adequately correct the overall impression created by the broader claims appearing earlier in the communications.

“By failing to adequately communicate the indication for Beyfortus, the emails create a misleading impression about the drug’s FDA-approved indication,” the letter states.

The agency concluded that the promotional materials “misbrand Beyfortus” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA requested that Sanofi take immediate action to stop disseminating the promotional communications or other materials containing similar representations.

The agency also instructed the company to submit a written response within 15 working days detailing all Beyfortus promotional communications containing comparable claims, along with its plan to discontinue or correct them.

If Sanofi believes its promotional materials do not violate federal law, FDA said the company may provide its reasoning and supporting evidence as part of its response.

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If You Want to Live, Stop Trusting the FDA, CDC, Corporate Media, and Jab-Pushing Doctors

If You Want to Live, You Have to Think For Yourself

I recently posted a flippant comment about not trusting the judgment of people who took the COVID jabs. The backlash was immediate and furious, and it only confirmed what I’ve known for years: too many people have outsourced their thinking to authorities who lie to them for a living.

The anger proves my point. When you confront people with evidence that their trusted institutions deceived them, they don’t want to hear it. They’d rather defend the authority that misled them than admit they were used as guinea pigs in a mass medical experiment. That’s not stubbornness; it’s deep psychological conditioning.

I make one exception: the active-duty military personnel who were physically coerced into taking the shots. The United States Coast Guard members who filed a class-action lawsuit against the Biden administration over its COVID-19 vaccine mandate were victims of medical assault, not naive volunteers. [1] Their “choice” was discharge, career destruction, and public humiliation. I have nothing but respect for the people who fought back.

The ‘I Trusted My Doctor’ Excuse Is Not a Defense

The most common justification I heard from angry commenters was some variation of “I trusted my doctor, the FDA, the CDC, the media, Fauci.” And that is exactly the problem. Your doctor was not the one who authorized an experimental gene therapy with zero long-term safety data. Your doctor was just the final delivery mechanism for a system that had already abandoned real science.

The Biden administration pressured the FDA to “change its procedures, cut corners, and lower agency standards” to approve Pfizer’s COVID-19 vaccines, according to a congressional report. [2] Emergency use authorization was never meant to bypass the entire clinical trial process, yet that is precisely what happened. Experts said that properly analyzing millions of pages of individual participant data would have required at least six months, so they skipped it entirely. [3]

Pfizer’s own whistleblower, Brook Jackson, testified that trial data were falsified, patients were unblinded, poorly trained personnel administered injections, and follow-up on reported side effects was significantly delayed. [4] Anyone with internet access could have found all of this information in real time from independent voices. Ignorance was a choice, and for too many people, it was a fatal one.

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FDA Continues Its Legacy of Radical Delays on FOIA Requests

We fund the government. We pay the salaries of its employees. They work for us—though they often seem to forget that. One of the ways we keep tabs on what they are doing is a tool called the Freedom of Information Act (FOIA). Congress passed this law specifically so that anyone can request emails, documents, records, etc., regarding the work our government is doing.

For years now, FDA has been dragging its feet when it comes to producing documents in response to FOIA requests. And not just dragging its feet—burying them in concrete. So much so that my firm has brought over 100 lawsuits against the federal government, on behalf of ICAN, just to get documents that should clearly have been produced. And even then, the government still drags its feet, wasting taxpayer money fighting us in court to generate more delay.

The 21-year FOIA request

Many of you are likely familiar with the FOIA case we filed for the Covid-19 vaccine licensure documents in which FDA wanted 75 years to produce the documents! Sadly, that was not an outlier. It was business as usual for the government in responding to FOIA requests.

Here is just one other example of FDA’s FOIA behavior. In a court filing on January 30, 2026, FDA told a federal judge that the FOIA request at issue, which was originally submitted on January 26, 2024, was “currently positioned 471” in the Center for Biologics Evaluation and Research (CBER) Complex Track. Meaning, it was behind 470 other requests. FDA then conceded it “cannot reasonably estimate” when that request will reach the top of the track. Let that sink in. It cannot even estimate when it will comply with the law.

It gets worse. FDA then asked the Court to pause the litigation for “at least eighteen months, through and including June 25, 2027.” By then, FDA explained, it “anticipates” that it “will be in a better position to evaluate when it might be able to respond” to the FOIA request. Read that again. It doesn’t even commit to producing the documents by 2027—instead that’s the date it will evaluate the request’s status. That is not a commitment. That is a dodge.

While FDA pretends it cannot provide an estimate, we can reasonably estimate when it will produce these documents based on recent movement in the queue. In a 6-month period, the request at issue advanced just 11 positions in the queue—from number 482 to 471. If that rate continues, it will take more than 21 years before this request reaches the top of CBER’s Complex Track.

So much for transparency. And this is a FOIA request under the jurisdiction of a federal court. Imagine those requests that are stuck at the administrative levels.

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Sen. Ron Johnson Unloads Devastating Safety Data on Fauci — Says COVID Shot Logged Nearly 7,000 Death Reports Per Year While FDA Ignored Warning Signs and Pushed Remdesivir

Sen. Ron Johnson (R-WI) dropped another bombshell during Wednesday’s explosive Senate hearing with Dr. Anthony Fauci, confronting the former COVID czar with adverse event data that he argued should have triggered urgent scrutiny years ago—but instead was ignored while federal health agencies relentlessly promoted COVID vaccines and Remdesivir.

Johnson’s latest exchange came after he previously confronted Fauci with stacks of studies on ivermectin and questioned why federal officials dismissed evidence supporting alternative treatments before Fauci invoked his Fifth Amendment right against self-incrimination during the hearing.

The Wisconsin senator displayed comparative adverse-event figures during the hearing, arguing they represented safety signals that federal regulators refused to adequately investigate.

“These are averages. Again, it doesn’t prove causation, but there’s correlation. It’s there. It’s there for a safety signal,” Johnson said.

The chart, titled “Drug Adverse Event Comparison” and labeled “FDA and CDC Data: Worldwide,” compared adverse event reports, total reported deaths, and average deaths per year across multiple products.

According to the chart presented by Johnson:

  • Ivermectin (30 years, 1996–2026): 5,127 adverse events, 518 deaths, averaging 17 deaths per year.
  • Hydroxychloroquine (HCQ) (38 years, 1988–2026): 37,270 adverse events, 5,404 deaths, averaging 142 deaths per year.
  • Flu vaccines (36 years, 1990–2026): 243,335 adverse events, 2,770 deaths, averaging 77 deaths per year.
  • Dexamethasone (57 years, 1969–2026): 143,017 adverse events, 25,589 deaths, averaging 448 deaths per year.
  • Tylenol (57 years, 1969–2026): 184,186 adverse events, 42,627 deaths, averaging 747 deaths per year.
  • Remdesivir (69 months): 10,657 adverse events, 2,751 deaths, averaging 546 deaths per year.
  • COVID-19 vaccines (68 months): 1,677,227 adverse events, 39,182 deaths, averaging 6,922 deaths per year.

The chart also highlighted that 9,342 reported deaths occurred on days 0, 1, or 2 following COVID-19 vaccination.

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The US Medical Establishment Can Never Be Reformed

People, now in unprecedented numbers, realize it’s become more than apparent that the US medical establishment is a grifting operation, choosing profits before people’s health.

The medical establishment’s corrupt alphabet organizations such as the FDA (Food and Drug Administration), CDC (Center for Disease Control), WHO (World Health Organization)… and other crooked institutions with its associated crooks continue unabatedly with their racketeering and wealth transfers.

It doesn’t matter who’s in charge of the HHS (Health and Human Services) either. The HHS are unable to make any lasting reform changes for the good of the people. I made this clear in an article I wrote earlier. Robert Kennedy Jr., the HHS boss, has not, and will not make any real difference to reforming the medical establishment. 

The same can be said about Trump. When he became president, Trump gave the impression to many Americans that he was the definitive outsider, opposed by system servers, who would make big changes for the betterment of the people, including the healthcare system. 

Many considered Trump and RFK Jr. to be the dream team, destined to change the medical establishment from the inside. But again, no reform has happened. 

You might consider these two individuals to have real intentions to make a difference. Or perhaps you don’t, seeing them as staged fake heroes. -This doesn’t really matter because ultimately, nobody, even those who are 100% genuine, will ever be able to reform the medical establishment given its structural organization.

The MAHA (Make America Healthy Again) was, and still is, a mere effrontery created to make it look as if something is being done about these profiteering, racketeering medical establishment grifters in power… —A setup, deliberately made to go nowhere.

The public are getting more and more aware that they’re being conned: More than ever, people are well-aware that highly toxic dangerous “vaccines” and aspects of “pandemics,” such as that associated with C-19, are a monumental fraud. -Fake diseases manufactured by the medical establishment for power, profits and political gains.

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What the FDA Knew—and When: The Case for a Black Box Warning on SSRIs for PSSD

A recent article in the DailyMail focused on what many who take antidepressants are reporting as sexual dysfunction. Apparently, Selective Serotonin Reuptake Inhibitors (SSRI), antidepressants not only cause people to feel nothing – not good, not bad -they also are unable to experience sexual pleasure…and it could be permanent.

The problem, of course, is more than sexual dysfunction. The bigger problem is that there is a risk of the psycho/pharma industry making the reported sexual dysfunction a mental illness, rather than call it what it is: an adverse effect of the SSRI drugs taken as “treatment” for depression. After all that’s what the psycho/pharmaceutical industry does…finds ways to profit from people’s feelings, even when those feelings are caused by that industry.

In fact, it is of interest that the DailyMail article refers to sexual dysfunction as a “condition,” writing the “American Psychiatric Association (APA) to help psychiatrists diagnose conditions states ‘in some cases, SSRI-induced sexual dysfunction may persist after agent (SSRI antidepressant) is discontinued.’” AbleChild cannot stress enough that the reported sexual dysfunction associated with antidepressant “treatment” is an adverse effect of the drug…not a mental disorder and certainly not something that needs to be “treated” with another mind-altering, mind-numbing drug.

Unfortunately, the inability to experience sexual pleasure is referred to as Post-SSRI Sexual Dysfunction (PSSD) and these adverse antidepressant side effects are not new. An increasing number of people are reporting experiencing PSSD, with symptoms that include genital dysfunction, loss of libido, difficulty or inability to reach orgasm and feeling muted or no sexual pleasure.

Some refer to PSSD as “emotional blunting,” but AbleChild would argue that antidepressants have long been reported to leave people feeling nothing. The overall feeling that comes with the antidepressant “treatment” is emotional blunting. It would appear that the answer from the psycho/pharma industry is that if someone is depressed, that can be “treated” by providing mind-altering drugs that make a person feel nothing. The patient won’t be depressed. The patient will feel nothing.

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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

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FDA Approves Merck Pneumococcal Vaccine for ‘At-Risk’ Kids as Young as 2

The U.S. Food and Drug Administration (FDA) expanded its approval of Merck’s pneumococcal vaccine Capvaxive for use in children ages 2 and up who are considered at increased risk for the disease.

The drug was specifically designed for adults, Merck said in a statement, but “may” offer additional protection for high-risk kids.

Critics pointed out that the vaccine adds to the list of childhood vaccines not tested against a placebo, and that it contains an ingredient linked to high rates of adverse events.

Children and teens with chronic conditions, including pneumonia, meningitis and bloodstream infections, can get the vaccine in addition to the pneumococcal conjugate vaccine (PCV) they already get as part of routine pediatric shots recommended by the Centers for Disease Control and Prevention (CDC).

The decision makes Capvaxive the only PCV approved as an extra vaccine for this group.

The vaccine protects against Streptococcus pneumoniae, which causes a wide range of bacterial infections, including pneumonia, bacterial meningitis and middle ear infections. The illnesses are typically treated with antibiotics.

CRM197: a questionable platform for childhood vaccines

The FDA based its expanded approval of the drug on results from a Phase 3 trial that enrolled 882 children and adolescents with chronic conditions.

The trial compared Capvaxive against PPSV23 (pneumococcal 23-valent polysaccharide vaccine), another vaccine that protects against pneumococcal illness — meaning it was not tested against an inert placebo.

Capvaxive contains CRM197, a protein. It is a mutant of the diphtheria toxin used to boost the immune response in some vaccines. In Capvaxive, bacterial sugars from 21 strains of pneumococcus are individually linked, or conjugated, to the CRM197, which enhances the body’s immune response to each of the bacteria.

Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker warned that giving a vaccine containing CRM197 to at-risk kids will be “another train wreck for children, but a boon for Merck as it opens up a fresh new market of children.”

That’s because research has found that other vaccines using the platform have high rates of adverse events.

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