Tag: fda

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.

Keep reading

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.”

Keep reading

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. 

Keep reading

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!

Keep reading

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 .

Keep reading

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.

Keep reading

FDA Exposed: Hundreds of Drugs Approved without Proof They Work

The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.

That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.

One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”

A System Built on Weak Evidence

The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.

Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.

Yet only 28% of drugs met all four criteria—40 drugs met none.

These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”

Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.

In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving that they work, with the promise of follow-up trials later.

But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”

“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.

More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively. 

And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.

The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.

Keep reading

FDA Plan To Include Hemp-Derived Cannabinoids In Federal Adverse Health Event Reporting System Goes To White House For Approval

The U.S. Food and Drug Administration (FDA) is moving forward with a proposal that aims to better track the health impacts of hemp-derived cannabinoid products by adding CBD and other hemp-derived cannabinoids as selectable options on federal documents used by healthcare professionals, patients and consumers to report adverse events.

Initially unveiled in January, the proposal would revise the “Product Type” field of FDA safety reporting documents to include a selection for “Cannabinoid Hemp Products (such as products containing CBD).” An initial round of comments was open until mid-March.

In a post published in the Federal Register this week, FDA announced that the “proposed collection of information” has now been submitted to the White House Office of Management and Budget (OMB) “for review and clearance.”

The new filing says that two comments were received in the initial round of public feedback supporting the addition of a “cannabinoid hemp product” category “but encouraged FDA to include additional categories as well that would allow for specific data as it pertained to a wider variety of individual products.” A third called for changes to make entries easier by respondents.

“FDA appreciates each comment and although we continue to modify applicable forms to increase the utility of the information collection as our limited resources allow,” the agency said, “we are proposing no other modifications at this time.”

An additional round of feedback is now being accepted on the submission of the information, with comments due by July 25.

The move—designed to more actively gather information about adverse health effects that might be linked to hemp-derived products—comes amid a number of other CBD-focused actions at the federal level and state levels.

Earlier this week, for example, a powerful House committee approved a spending bill containing provisions that hemp stakeholders say would devastate the industry, prohibiting most consumable cannabinoid products that were federally legalized during the first Trump administration.

The House Appropriations Committee passed the agriculture appropriations legislation in a 35-27 vote on Monday. It now heads to the Rules Committee to be prepared for floor consideration.

While the panel adopted a manager’s amendment to a report attached to the bill earlier this month that provided clarifying language stating that members did not intend to prohibit non-intoxicating cannabinoid products with “trace or insignificant amounts of THC,” the underlying bill went unchanged, despite the industry’s concerns about the proposal.

Keep reading

FDA, CDC advisers say lost pregnancies higher than expected following early mRNA vaccination

President Trump’s second-term agenda has been careful not to cast doubt on his signature first-term achievement, the development of COVID-19 vaccines through Operation Warp Speed, which congressional Republicans continue to laud and even claim was sabotaged by Pfizer to deny Trump a consecutive term despite his base souring on the therapeutics.

A new preprint study on mRNA COVID vaccines in early pregnancy, coauthored by top advisers to Trump’s Food and Drug Administration and Centers for Disease Control and Prevention, may fuel the splintering of the Make America Healthy Again movement as the jabs’ opponents ramp up pressure on Health and Human Services Secretary Robert F. Kennedy Jr. to ban them.

Not yet peer-reviewed, the study analyzed hundreds of thousands of Israeli medical records on pregnant women in the three years before and after SARS-CoV-2 emerged in China, finding 43% more “observed-to-expected” fetal losses per 100 pregnancies — 13 instead of nine — when the first mRNA dose is taken between 8-13 weeks’ pregnancy.

Pregnant women who took a booster between 8-13 weeks lost an additional two pregnancies per 100, a “potential dose-response relationship,” the study said.

By using pregnant women who got flu vaccines between 8-27 weeks and women who received either vaccine before their pregnancy as “comparative controls,” the authors said they were able to show the association is unique to COVID vaccines. 

The former had a “consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias” – in which people with overall better health tend to have higher vaccination rates – while the latter had “according-to-expected or lower-than-expected numbers of fetal losses,” the study found.

It said “almost all” mRNA doses were made by Pfizer, whose own 2021 report to the FDA – which the agency hid for 16 months until a court made it public – shows 44% of women in Pfizer’s clinical trial lost their pregnancies.

Keep reading

FDA halts Biden-era program of sending Americans’ DNA to China for genetic engineering

The Trump administration is halting companies from conducting clinical trials in China using Americans’ DNA samples in a program authorized by the Biden administration, according to the Food and Drug Administration.

The FDA said an immediate review has begun on new clinical trials that involve sending living cells of U.S. citizens to China and other hostile states for “genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent.”

The agency moved to halt the program based on what it said is mounting evidence that some of the trials were conducted without informing people involved that their biological material was being transferred and manipulated.

The activity “may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries,” the FDA said in a statement Wednesday.

FDA Commissioner Marty Makary said the unacknowledged transfer of DNA samples has raised questions about the integrity of U.S. biomedical research.

“We are taking action to protect patients, restore public trust and safeguard U.S. biomedical leadership,” Dr. Makary said. “The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” he said.

The FDA said the suspect transfer of Americans’ biomedical samples was the result of a December 2024 policy by the Biden administration that was put in place by the Justice Department in April.

The Biden rule imposed export controls that limited the transfer of sensitive data to countries of concern. But the Biden administration specifically approved a “sweeping exemption” that allowed U.S. companies to send trial participants’ biological samples, including DNA, for processing overseas in FDA-regulated clinical trials.

Keep reading