Tag: fda

Paul “Vaccine Puppet” Offit BUSTED exposing the absolute FRAUD of the FDA’s vaccine “licensure” protocol

The man who put a deadly pig virus in the Rotateq Rotavirus vaccine and made millions off it (pardon the pun with his name), just got busted exposing the ultimate dirty vaccine fraud and vaccine failure. The puppet of the vaccine industrial complex is a scam artist of the highest and most insidious magnitude, but he loves to run his mouth about it all. This is the same dirty vaccine pushing schmuck who admitted that vaccines are a violent act.

Many parents today are concerned about the number of vaccines their children are scheduled to receive under the Centers for Disease Control and Prevention (CDC) guidelines. As a more cautious approach, some parents seek antibody titer tests — blood tests that measure a child’s existing immunity to specific diseases — to potentially avoid unnecessary vaccinations.

  • Paul Offit Dismisses Antibody Testing, But Ignores Valid Parental Concerns: In a CHOP video, Dr. Paul Offit argues that antibody titer tests are unreliable indicators of immunity and urges parents to follow the CDC vaccine schedule instead. However, his argument fails to address legitimate safety concerns and presumes, without evidence, that the full schedule is safe.
  • Scientific Contradictions and Vaccine Licensing Exposed: Offit acknowledges that antibody levels don’t always correlate with immunity — yet this is the very measure the FDA uses to license vaccines. This contradiction reveals a major flaw in the FDA’s approval process and raises questions about the scientific validity of current vaccine policy.
  • Evidence of Vaccine Failure Undermines Offit’s Position: Offit cites past measles outbreaks to justify vaccination but omits that a significant portion of cases occurred in fully vaccinated individuals. Historical data show that vaccine failure — both primary and secondary — was a driving force behind adding a second measles dose to the schedule.
  • Undisclosed Conflicts of Interest Raise Ethical Red Flags: Offit’s financial ties to the pharmaceutical industry — including profits from a Merck rotavirus vaccine — go undisclosed in the CHOP video. This, combined with CHOP’s industry partnerships, casts doubt on the objectivity of their messaging and underscores concerns about propaganda replacing informed consent.

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Top FDA Official Resigns in Disgrace After Exposé by Investigative Journalist Laura Loomer

Dr. Vinay Prasad — a radical left-wing ideologue who wormed his way into one of the most powerful regulatory roles in the federal government — has officially resigned from the Food and Drug Administration following a explosive exposé led by investigative journalist Laura Loomer.

For weeks, Loomer publicly exposed Prasad’s shocking anti-Trump rhetoric, far-left allegiances, and dangerous abuse of regulatory power.

“We have a crisis at the FDA! A wolf in sheep’s clothing is sabotaging President Trump’s bold “Make America Healthy Again” (MAHA) agenda!” Loomer wrote on X.

Loomer continued, “This is no mere bureaucratic misstep. It’s a catastrophic vetting failure that threatens to derail the America First healthcare revolution. Prasad’s anti-Trump rhetoric, radical left-wing ideology, and deliberate actions to obstruct our President’s deregulatory mission prove he’s a dangerous misfit. The time to act is NOW—Prasad must be REMOVED before he destroys Trump’s vision for a healthier America!”

According to Loomer:

In 2021, Prasad described himself as a “political liberal, closest to Elizabeth Warren” and a “Sanders/Warren liberal,” proudly embracing a progressive identity. He voted for Bernie Sanders in the 2016 Democratic primary, and FEC records reveal he donated to Sanders’ campaign, signaling his support for radical left-wing policies.

In 2020, Prasad declared on X that he wanted “Biden to win more than anything” and confirmed he voted against Trump, solidifying his opposition to the President.

Prasad’s policy positions are a direct affront to the conservative principles underpinning Trump’s agenda. He advocates for universal basic income, student loan forgiveness, open borders, and Roe v. Wade abortion standards. He supports a 50% marginal tax rate for high earners, a wealth tax, single-payer healthcare, universally funded pre-K and community college, and expansive parental leave policies.

[..]

Prasad’s disdain for Trump is personal and vitriolic. He has called the President “perhaps the worst president in the history of the Republic.” Prasad has claimed that Trump disagreed with him “on probably 90% of issues.” He compared Trump’s family separation immigration policy to a “human rights violation” worthy of the International Criminal Court. Prasad mocked his election fraud claims as “laughable and pathetic,” and called January 6 “a terrible day.” Further, he even attacked Trump University as a “scam.” Prasad consistently refers to the President as “orange man.” This is a derogatory jab used by the radical Left to attack Trump over his tan skin. Prasad has a strong admiration for Dr. Anthony Fauci, whom he dubbed “St. Anthony of Fauci” with “profound reverence.” Thisfurther highlights his alignment with figures Trump has criticized, particularly over the COVID-19 response.

Since assuming control of CBER at the FDA, Prasad has amassed unprecedented power. He holds three key FDA roles: Chief Medical Officer, Chief Scientific Officer, and Director of CBER. Reports suggest he is under consideration to lead the Center for Drug Evaluation and Research (CDER). This could make him more influential than FDA Commissioner Marty Makary. Moreover, this consolidation of authority in the hands of a Trump antagonist and avowed Leftist is a recipe for disaster. Prasad’s actions further demonstrate a clear intent to undermine President Trump’s vision.

Read more here.

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FDA allows distribution of muscular dystrophy drug again after public criticism

After blocking a new muscular dystrophy therapy in order to investigate patient deaths, the Federal Drug Administration reversed course after criticism and restored hope to parents seeking a treatment to aid children affected by the debilitating disease. 

The FDA’s initial decision to freeze distribution of the therapy, marketed as Elevidys, following at least three patient deaths potentially connected to the therapy, stirred criticism from advocates for muscular dystrophy patients and from health policy experts. Added to the mix of criticism about the initial decision were the attacks and defenses of Dr. Vinay Prasad, the agency’s top biologics official, who supported progressive candidates and criticized several of President Trump’s key health policies in the past. 

The company that produced the therapy, Sarepta Therapeutics, initially resisted the freeze, but eventually paused shipments of its innovative product, opening its stocks up to a hammering that threatened to put the company’s future in serious jeopardy. According to financial analytics website companiesmarketcap.com, Sarepta’s market cap fell yesterday to $1.56 billion from $14 billion a year ago. Market capitalization, commonly called market cap, is the total market value of a publicly traded company’s outstanding shares — held by institutional investors and the public at large — and is commonly used to measure how much a company is worth.

The “Right-to-try”

The reversal of the pause aligns with President Donald Trump’s longtime advocacy for the right-to-try. During his first term, the president signed a new law giving terminally ill patients the opportunity to seek new or experimental treatments without obtaining the approval of the FDA, which had been required in the past. 

The FDA demanded on July 18 that Sarepta pull Elevidys from the market and halt all shipments to patients after reports of two deaths connected to the treatment. Elevidys is not an experimental drug, and was approved by the FDA under certain circumstances in 2024. It is a prescription gene therapy designed to treat patients with Duchenne Muscular Dystrophy, a genetic disorder that leads to the breakdown and decay of muscles over time and mostly impacts male children. 

Despite initially refusing to voluntarily pause shipments of the therapy, Sarepta eventually agreed to a “temporary pause” to allow “the necessary time to respond” to the FDA and to finish the “safety labeling supplement process.” 

The reaction was immediate. After the pause was announced, the Parent Project Muscular Dystrophy, a nonprofit organization dedicated to ending the disease by supporting research and advocating for care, criticized the decision. 

“These reports are profoundly upsetting and raise serious concerns for our entire community,” PPMD said in a statement. “Families who have fought tirelessly for access to this therapy, those who have already received it, and those who are in line to receive it are now left with more questions than answers.” 

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Antidepressants During Pregnancy Raise Risk of Birth Defects, Doctors Tell FDA

The U.S. Food and Drug Administration (FDA) needs to do a better job of warning pregnant women that taking SSRIs, a type of antidepressant, may harm them and their developing baby, doctors told the agency Monday.

The FDA hosted an expert panel of developmental biologists, psychiatrists, epidemiologists, obstetricians and mental health experts who discussed selective serotonin reuptake inhibitors (SSRIs) and pregnancy. The agency livestreamed the two-hour conversation on YouTube and X.

SSRIs have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects,” said FDA Commissioner Marty Makary, who opened the event.

Nearly 1 in 4 middle-aged women and up to 5% of pregnant women are on an antidepressant, Makary said.

“Antidepressants like SSRIs can be an effective treatment for depression, but we have to stop and also look at the big picture,” he said. “The more antidepressants we prescribe, the more depression there is. … We have to start talking about root causes.”

SSRIs in particular warrant scrutiny as serotonin “may play a crucial role in the development of organs of a baby in utero,” he said.

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Ghost Shot: Pfizer quietly admits it will never manufacture original FDA approved COVID vaccines

The August 23, 2021 FDA approval of Pfizer’s Comirnaty vaccine was a cause for celebration. Marked as a turning point in the battle against COVID19, the announcement was highly publicized by the Biden Administration with the clear intention to extinguish “vaccine hesitancy” and boost uptake.

It was celebrated as a cause for national relief, and many Americans arrived at their local pharmacies under the impression, via government and pharmaceutical propaganda, that they were receiving an FDA-approved COVID vaccine. Yet that legally distinct product, as we know it, never existed. And now we know, via Pfizer, that it will never exist.

For the uninitiated:

Comirnaty is a legally distinct product from the emergency use authorization (EUA) shots, and It has never made its way to market. For months on end, no such vaccine has ever become available. Those who received the “Pfizer shot(s)” have been injected with the emergency use authorization (EUA) version of the shots.

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FDA Rejects Moderna Jab for Healthy Children

For years, it’s been common practice at the FDA to routinely approve upgraded versions of existing vaccines with an oversight process best described as rubber stamping.

But the days of the FDA quietly approving vaccines may be over – bright news for activists from the Medical Freedom Movement.

Earlier this week, Dr. Vinay Prasad, the man who replaced Peter Marks, the FDA’s controversial vaccine official, boldly overruled FDA regulators who had recommended all three COVID vaccines for all age groups, including healthy children.

While the approval process for vaccines gives regulatory bodies the opportunity to scrutinize products before they hit the market, in reality, this hardly ever happened. Today, however, FDA leadership is empowered to scrutinize vaccines to insure their safety.

More importantly, the current FDA is challenging the past orthodoxy of a “one-size-fits-all” approach. In its place: the empirical “gold standard” scientific analysis that HHS Secretary Robert F. Kennedy Jr. had been promising.

Dr. Prasad, the new head of the FDA’s Center for Biologics Evaluation and Research (CBER) – which regulates vaccines, blood products and more – explained this new approach both online and in a detailed memorandum.

In his memo, Dr. Prasad writes that in considering the approval of Moderna’s updated mRNA COVID vaccine (“SPIKEVAX”), the FDA must weigh the benefits of the product against its risks. Only then can a specific approval process result in a scientifically sound recommendation. “FDA has a statutory mandate to only approve products when we have substantial certainty that benefits outweigh harms,” Prasad writes in his memo. Referring to Moderna’s submission, he adds, “We do not have substantial certainty [that] benefits outweigh risks of healthy children.”

Dr. Prasad elaborates: “First, consider that COVID-19 severe disease, hospitalization, and death are extremely low at pediatric ages and have fallen, according to US CDC data from 2021-22 to the present.”

Dr. Prasad continues, “These rates are lower in healthy children than in children with risk factors. Notably, the applicant has agreed to a revised submission that focuses on children with risk factors, and FDA CBER has granted this approval.”

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In era of skepticism, FDA clears Moderna COVID vaccination for some kids up to 11 years old

In what many view as a sharp departure from the Make America Healthy Again (MAHA) agenda and priorities of people like Food and Drug Administration (FDA) Commissioner Marty Makary and Health and Human Services (HHS) Secretary Robert F. Kennedy, the FDA approved Moderna’s COVID-19 vaccines for children, aged six months through 11 years who are at increased risk for the virus. 

The FDA has approved the Spikevax vaccine for that age bracket who are at increased risk of COVID-19 disease. The approval applies to a supplemental Biologics License Application (sBLA), which means that the FDA is requesting updates or changes to an already approved biological license for a product such as a vaccine.  It’s often used for new indications, changes in dosing, new formulations or, in this case, to transition the vaccine from Emergency Use Authorization (EUA) to full approval. Spikevax is a brand name used by Moderna for the vaccine.

Under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, the FDA says it “may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear threats.”

The information sheet included in the packaging tells users or physicians that “SPIKEVAX does not contain SARS-CoV-2, the virus that causes COVID-19. SPIKEVAX cannot give you or your child COVID-19.” It also says that the use is appropriate for patients aged 6 months through 64 years of age who are at high risk of severe COVID-19.

The FDA also authorized the Moderna COVID-19 Vaccine (2024-2025 Formula) under EUA for all children aged 6 months through 11 years, targeting the Omicron variant KP.2 strain. 

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America’s Frontline Doctors Petitions FDA to Make HCQ and Ivermectin Over-the-Counter

On June 26, 2025, Dr. Simone Gold and America’s Frontline Doctors filed two Citizen Petitions with the U.S. Food and Drug Administration (FDA) to convert both hydroxychloroquine and ivermectin from prescription-only status to full over-the-counter (OTC) status.

Dr. Gold and AFLDS were joined by doctors Dana Granberg-Nill, Bryan Atkinson, Pierre Kory, Brian Tyson, Peterson Pierre, Robin Armstrong, Geoff Mitchell, and Lynn Fynn as co-petitioners.

By submitting these petitions to the FDA, AFLDS is taking critical action to empower the American people and ensure easy access to life-saving medications.

Hydroxychloroquine (HCQ) has been FDA-approved for decades and is available OTC in many parts of the world, such as in Africa and South America, for the prevention and treatment of malaria.

In the United States and other Western Nations, HCQ is a widely prescribed medication primarily used to treat rheumatoid arthritis and lupus. According to the government’s own database, FAERS (FDA Adverse Event Reporting System), HCQ is one of the safest drugs on the planet.

Ivermectin is a wide-ranging antiparasitic agent that has been used in humans for over three decades and won the Nobel Prize in Medicine in 2015, reflecting the drug’s enormous impact on human health.

Considered extremely safe, ivermectin is FDA-approved to treat threadworm infection and river blindness, with millions of treatments administered in global public health campaigns.

Although it is used to treat parasites, ivermectin has gained much attention for its potential use in cancer treatment. There is absolutely no dispute that both of these drugs are extremely safe.

The COVID pandemic sparked a tremendous public health demand to repurpose well-known drugs like HCQ and ivermectin for new uses, specifically for the prevention and treatment of COVID-19.

Tragically, patients who were prescribed these medications by their doctors were denied access by pharmacies that refused to fill these prescriptions due to pressure from government health agencies and their C-suite executives.

This unnecessary barrier prevented countless Americans from accessing safe and effective medication in the middle of a pandemic.

To make matters worse, both drugs were attacked relentlessly in order to push experimental mRNA injections onto the public.

Despite their tremendous safety profiles and potential, these generic medicines are not profitable to Big Pharma, so there is no financial incentive to convert them to OTC status. In short, profits are being prioritized over cheaper alternatives.

Recognizing the importance of cutting through the COVID propaganda and removing this barrier to patient access, Dr. Gold and AFLDS filed a Citizen Petition with the FDA to make HCQ available OTC in October 2020.

By refiling our petition for HCQ along with a new petition for ivermectin, we are reactivating this fight. The American people deserve access to safe and effective medicine without government interference!

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The Profit Motive Itself Makes the Best Case Against the FDA

One of President Trump’s campaign pledges was to allow Robert F. Kennedy, Jr. to “go wild” as head of Health and Human Services. Some welcomed the idea, scarred by memories such as covid lockdowns and government mask mandates that lasted well beyond the arrival of the vaccines. Others, well aware of Kennedy’s conspiracism and anti-vaccine views, dreaded the news. Agencies under Kennedy, like the FDA, are charged with maintaining standards of medical safety and effectiveness. Does “go wild” mean freeing Americans to make our own health decisions — or ramming bad advice down our throats?

As if to address the concerns of both groups, Kennedy’s FDA announced in May that it approves covid boosters only for those over 65 or in other high-risk groups. The vaccine remains available to everyone, but insurers are no longer forced to cover the full cost (about $150). If you want to get the covid jab with your flu shot, you’ll need to decide if a few extra days of health are worth the price. Leftists wailing about “access” notwithstanding, Kennedy hasn’t “taken away” this vaccine.

The measure seems reasonable until one hears the rationale: Officials described the old guidance as “one-size-fits-all” and based on the assumption that Americans “are not sophisticated enough to understand age- and risk-based recommendations.” First, millions were forgoing the shots. Second, the main impact is on insurance companies, whose job it is to know whether covering shots or treatments is profitable for any given group.

This comes across as an attempt to flatter voters who should be wondering: Why is someone, who sues vaccine makers and has no medical or scientific background or experience, in charge of what vaccines are available and what health insurers can or can not cover?

We know the short answer: Donald Trump wanted to reward Kennedy’s support for his presidential campaign more than he cared about the health of his voters — and nearly every Republican Senator (including four M.D.s !) went along with it.

But this dumpster fire would be impossible if the government weren’t running the biomedical sector of the economy, rather than just protecting our freedom like they are supposed to.

Contrary to the notion that we need a government to ensure safe and effective drugs, there is ample evidence that the profit motive is necessary and sufficient for this purpose .

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FDA Announces New Safety Warning on All mRNA COVID Vaccines — Cites “Extremely High” Risk of Myocarditis and Long-Term Heart Damage in Young Men

The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines to reflect what many Americans have been warning about for years: a disturbingly high risk of myocarditis—particularly in young men—and the possibility of long-term, irreversible heart damage.

The revised warnings apply to both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines and follow months of mounting pressure over transparency and accountability regarding the true risks of these experimental injections.

The update stems from new studies and data showing persistent cardiac abnormalities months after vaccination—especially among males aged 12 to 24.

During a presentation of the new FDA safety data on Tuesday, Dr. Vinay Prasad, Director, Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, walked the public through the harrowing evidence behind the label change.

Prasad detailed how FDA data reveals a myocarditis rate of 27 per million in young men—a figure that experts say is significantly underreported due to passive surveillance methods and political suppression of adverse event reports.

More troubling, Dr. Prasad cited late gadolinium enhancement (LGE) on cardiac MRIs as proof of sustained, potentially irreversible myocardial injury. According to Prasad, in one FDA-funded study, 60% of patients who suffered post-vaccine myocarditis still showed signs of LGE five months later.

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