Tag: fda

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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FDA Altered Autopsy Results of Children Who Died After COVID Vaccines

Scientists at the U.S. Food and Drug Administration (FDA) revised the autopsy results of children who died after receiving the COVID-19 vaccine, reducing the number of children the agency classified as having likely died as a result of their vaccination, according to documents released last week by Sen. Ron Johnson (R-Wis.).

The documents show that in November 2025, the FDA’s Center for Biologics Evaluation and Research (CBER) identified 10 child deaths related to the COVID-19 shots. But in December 2025, it reduced the number to seven and downgraded the probability that those deaths were connected to the children’s vaccination.

The Daily Caller, which first reported, quoted two former FDA officials and a forensic pathologist who performed two of the children’s autopsies. One of the FDA officials told the outlet the emails reveal “a coverup” by the FDA and the Centers for Disease Control and Prevention (CDC).

Johnson included the documents in a letter sent last week to U.S. Health Secretary Robert F. Kennedy Jr., CDC Acting Director Jay Bhattacharya and FDA Acting Commissioner Kyle Diamantas.

Even the reduced number of deaths was enough to trigger concern among some FDA scientists about the safety of the COVID-19 shots, Johnson’s letter stated.

“Although what drove the decision to change these three cases remains to be seen, what is clear is that these officials appear to have determined that the seven cases warranted warning about the risks,” Johnson wrote. These risks “should have raised serious concerns at HHS and CDC about the mRNA COVID-19 Injections.”

Even after the downgrade, the FDA’s Division of Pharmacovigilance recommended revising the label of the Pfizer and Moderna mRNA COVID-19 vaccines to include a warning about the risk of “myocarditis with fatal outcomes.”

The change was never made, for reasons that are not clear.

Myocarditis is widely associated with the mRNA COVID-19 vaccines and, with reports of deaths connected to the vaccines, particularly among teenage and young adult males.

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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.

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Senate Investigation Finds FDA Officials Covered-Up 25 COVID Shot Safety Signals

A new Majority Staff Interim Report from Sen. Ron Johnson’s Permanent Subcommittee on Investigations was released today (April 29, 2026), titled Unmasked: How Biden Health Officials Purposely Turned a Blind Eye Toward COVID-19 Vaccine Safety Signals.

In early 2021 — just weeks after the COVID-19 vaccines rolled out under EUA — FDA senior medical officer Dr. Ana Szarfman (a key developer of the agency’s own data mining system) teamed up with Dr. William DuMouchel (the statistician who literally invented FDA’s “gold standard” EB data mining algorithm) to run an upgraded analysis on VAERS data.

Their new method (Regression-Adjusted Gamma Poisson Shrinker — RGPS) fixed a known flaw called “masking” — where signals for one COVID vaccine get drowned out by the sheer volume of reports from the others.

What they found was explosive:

  • 49 examples of extreme masking
  • ~25 new statistically significant safety signals that FDA’s standard MGPS method completely missed
  • Signals included: sudden cardiac death, acute myocardial infarction, pulmonary infarction, Bell’s palsy, non-site specific embolism/thrombosis, dementia, and “Death and sudden death” — for Pfizer, Moderna, and J&J shots

Dr. Szarfman repeatedly shared these findings with senior CBER officials (the very people in charge of vaccine safety), including Dr. Peter Marks, in March, April, May, and July 2021.

Their response?

  • Told her to “hold off” on creating and sending any more data mining reports
  • Called her work a “major distraction”
  • Worried it would “create erroneous conflicts that feed into anti-vaccination rhetoric”
  • Eventually ordered her to “cease and desist”

Later, FDA quietly locked down distribution of its own weekly data mining reports to CDC — right around the time FOIA requests and Sen. Johnson’s letters started coming in. One CDC official even admitted they may have asked FDA to stop sending them “because of the FOIAs.”

Even after Dr. Szarfman and DuMouchel published their findings in Drug Safety (2022) showing masking was eight times more likely with COVID vaccines, and Dr. Robert Califf replied “Thanks. These are good,” no changes were made to the methodology.

This is documented, internal FDA communication showing deliberate suppression of safety signals at the exact moment millions of Americans were being told the shots were “safe and effective.”

The cover-up continues to unravel. Accountability is urgently warranted.

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Inside The FDA’s “Cover-Up” Of Child Deaths Linked To Covid Vaccines

In September 2025, then-US Food and Drug Administration (FDA) Commissioner Dr Marty Makary publicly acknowledged that the agency was investigating reports of child deaths following Covid-19 vaccination.

“We do know at the FDA…that there had been children who have died from the COVID vaccine,” Makary said during a CNN interview.

By that stage, however, a fierce internal dispute had already emerged inside the FDA over what investigators believed the evidence showed – and whether the public should ever see the full findings.

“It really did feel like there was some sort of cover-up going on about the Covid-19 vaccines,” said one individual familiar with the discussions.

MD Reports spoke with several current/former agency officials, advisers, and individuals briefed on the discussions, all of whom requested anonymity because they were not authorised to publicly discuss internal FDA deliberations.

At the centre of the controversy was an internal FDA review led by Dr Tracy Beth Høeg, a physician-scientist who was working as a senior scientist inside the FDA’s vaccine division at the time.

FDA officials examined roughly 96 paediatric death reports submitted to the Vaccine Adverse Event Reporting System (VAERS), the government database used to detect potential vaccine-related adverse events.

The review included medical records, autopsy reports, pathology findings, and follow-up investigations conducted by agency staff.

About 25 deaths following Covid vaccination were ultimately considered serious enough for high-level internal discussion inside the agency.

The findings were expected to be presented at a September 2025 meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), the federal panel that shapes US vaccine recommendations.

But before that could happen, details of the review leaked to the New York Times and the Washington Post.

Høeg quickly became the focus of intense media scrutiny and criticism from vaccine advocates and unnamed FDA officials who argued she was relying too heavily on VAERS reports and overstating preliminary findings.

People familiar with the fallout said some FDA staff strongly objected to Høeg’s methods and conclusions and allegedly sought to undermine her credibility by leaking details of the review.

The leak effectively ended plans for a public ACIP discussion and deepened divisions within the FDA over how the findings should be handled.

Some officials believed the findings warranted stronger warnings and greater transparency. Others feared public acknowledgement of vaccine-linked child deaths would damage confidence in the Covid vaccines.

“We know that there are these deaths that are due to the vaccine,” said one source, referring to myocarditis cases and published reports from countries including Korea and Israel.

The controversy intensified after then-FDA vaccine chief Dr Vinay Prasad ordered additional investigation into the deaths identified in Høeg’s review.

Months later, another leak brought the issue back into public view.

In November 2025, an internal memo circulated by Prasad became public. In it, Prasad acknowledged that “at least 10” children had died “after and because of receiving Covid-19 vaccination.”

He described the findings as “a profound revelation.”

“COVID-19 vaccines did result in the death of children,” Prasad wrote. “Dr. Hoeg was correct in her assessment.”

The memo triggered another round of backlash from media outlets and vaccine advocates, many of whom accused Prasad of overstating the evidence before the agency’s analysis had been finalised.

Inside Medicine reported on a Dec 5 memo about a subsequent FDA analysis using a World Health Organization causality framework, which classified zero deaths as “certain,” two as “probable/likely,” and five as “possible.”

But individuals involved in the discussions said pressure steadily mounted inside the agency to “downgrade” the findings with each successive review.

“It seemed like there was a lot of pressure to keep decreasing the number of deaths,” said one source.

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