Tag: fda

FDA Leadership Refuses to Add Black Box Warning to mRNA Injections—Despite FDA Scientists Recommending It

A few days ago, CNN reported that the FDA intended to place a black box warning on COVID-19 mRNA injections for serious adverse events, including death.

However, in a striking reversal first reported by Maryanne Demasi, FDA Commissioner Dr. Marty Makary appeared on Bloomberg and claimed the agency now has “no plans” to implement a black box warning—despite the FDA’s own Center for Safety and Epidemiology formally recommending one. He claimed that Dr. Vinay Prasad and “leadership” thought it would be a bad idea.

Dr. Makary stated:

Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine. The Safety and Epidemiology center within the FDA did recommend that it was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said it may be different today than it was in the first year of COVID when the shot came out.

Because when you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people. Now that it’s annual, you may not see that same prevalence.

So we don’t want to extrapolate findings to today if it’s not transferable.

This rationale is deeply flawed—and gravely worrisome. It assumes that cardiotoxic injury from mRNA injections is acute, transient, and dose-interval dependent, rather than structural, cumulative, and capable of causing delayed fatal outcomes. That assumption is directly contradicted by the peer-reviewed literature.

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Head of FDA Says Biden Administration Hid Data On Heart Risks From COVID Vaccines

The head of the Food and Drug Administration (FDA), Commissioner Marty Makary, claimed that the Biden administration withheld data from the public on the risks of myocarditis from the COVID-19 vaccine. This vaccine was created and pushed by the first Trump Administration under Operation Warp Speed. 

Trump has taken full responsibility for implementing the mass vaccine policy rolled out to the public at “warp speed.” However, the FDA appears to be placing the blame for hiding safety and efficacy data on the Biden administration.

“We have done more to study myocarditis and to go back and look at deaths of people, of children from the Covid vaccine,” Makary told NBC News in an interview. “Internal data submitted on myocarditis, we found that the Biden administration was sitting on data on myocarditis in young people, and it was not made public.”

Makary’s claim comes less than a week after Vinay Prasad, the FDA’s top vaccine regulator, told agency staff in a memo that an internal review found that at least 10 children died “after and because of receiving” the Covid shot. Prasad suggested — without evidence to support his claim — that the child deaths were tied to myocarditis. –NBC News

Pfizer Scientist Says The Company Is Looking Into Myocarditis From The Shots

Myocarditis has been one of the sticking points for “anti-vaxxers”. When it comes to health and safety, the heart should not be on line.

But even those who have taken the shots are now noticing that they may not have been as safe as originally indicated. In May 2021, around the same time Pfizer’s COVID-19 shot was authorized for young teenagers, the Centers for Disease Control and Prevention’s (CDC) vaccine safety group said it was reviewing reports of heart inflammation in young people.

Others claim that the ruling class did not pressure the FDA to approve the COVID injections and that there was no wrongdoing.

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FDA Set to Give COVID Vaccines Serious ‘Black Box’ Designation: Report

The U.S. Food and Drug Administration is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, according to a CNN report citing people familiar with the agency’s plans.

A black box warning is the most serious safety designation the FDA can require — appearing in bold at the top of a drug or vaccine’s prescribing information to alert doctors and patients to potentially serious risks.

According to CNN, the FDA’s proposed action would highlight major risks such as serious side effects and usage restrictions that should be weighed against benefits before administering the shots.

The report says two people familiar with the agency’s internal planning confirmed the intention to add the warning, though the plan has not yet been finalized and could change before it is publicly announced.

Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and head of the Center for Biologics Evaluation and Research, is said to be leading the review of the COVID vaccine warning label.

CNN’s account indicates that officials are still determining whether the black box warning would apply to all COVID vaccines, only mRNA-based shots from manufacturers like Pfizer and Moderna, or specific age groups.

The warning is expected to be unveiled before the end of 2025, though agency officials have not publicly confirmed plans.

Black box warnings are typically reserved for medicines with evidence of serious or potentially life-threatening adverse reactions that must be clearly communicated to providers and patients.

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Children’s Health Defense Files CITIZEN PETITION Urging FDA to Revoke COVID Vaccine Licenses After Evidence Agency Violated Its Own Approval Rules — Here’s How Americans Can Submit Comments

Children’s Health Defense (CHD) has filed a sweeping Citizen Petition demanding that the U.S. Food and Drug Administration (FDA) immediately revoke the biologics licenses for all Pfizer-BioNTech and Moderna COVID-19 vaccines — Comirnaty, Spikevax, and their licensed analogues.

CHD alleges that the Biden-era FDA broke its own laws, bypassed mandatory safeguards, ignored manufacturing violations, and labeled experimental EUA products as “fully licensed vaccines” without the clinical, manufacturing, and regulatory compliance required under federal law.

According to CHD, the public, including doctors, nurses, parents, service members, and anyone affected by the mandates, may now submit comments directly to the FDA docket and demand the agency follow the law.

This petition could become the most consequential public challenge to COVID-19 vaccine licensure since 2020.

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It’s ‘Unclear’ How Feds Will Enforce Hemp THC Product Ban, Congressional Researchers Say, Citing Limited FDA And DEA Resources

Congressional researchers say it “remains unclear” how the federal government might enforce a newly enacted law that takes effect next year banning hemp THC products—flagging concerns about a potential lack of resources on the part of the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).

After President Donald Trump signed appropriations legislation late last month that included language that effectively “reimposes” hemp criminalization, the Congress Research Service (CRS) published an analysis about the policy change on Wednesday.

“While the change to the hemp definition will seemingly alter the legal status of many hemp products currently available on the market, it remains unclear if and how federal law enforcement will enforce the new prohibitions when the new definition goes into effect,” the researchers said.

Part of the uncertainty around hemp is related to the federal approach to marijuana, which has been legalized in some form in the vast majority of states but remains federally illegal as a Schedule I drug under the Controlled Substances Act (CSA).

“In marijuana’s case, the federal response has largely been to allow states to implement their own marijuana laws despite the fact that state-regulated activities may violate the [Controlled Substances Act],” CRS said. “If intoxicating hemp products persist on the market after the change to their legal status, it is possible they could be subject to the same criminal and collateral issues as marijuana.”

The analysis added, however, that it “remains to be seen” whether FDA will “pursue additional options to remove these [hemp] items from the market.

FDA and the Drug Enforcement Administration “may lack the resources to broadly enforce the laws prohibiting intoxicating hemp products on the market,” it said, adding that congressional lawmakers may also “choose to exercise oversight over federal enforcement priorities regarding state-regulated cannabis activities.”

FDA and DEA, “in coordination with the Department of Justice, have a range of civil and criminal remedies they may use in efforts to exercise control over these activities,” the report says.

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Teen Who Died 5 Days After Pfizer Vaccine Among 10 Deaths FDA Cited In Leaked Memo

Last week, a leaked FDA memo acknowledged that at least ten children died “after and because of” the COVID-19 vaccine in the U.S.

None of those children had been identified — until now.

One of them is now understood to be Ernesto Ramirez Jr., a 16-year-old from Texas who collapsed and died five days after receiving the Pfizer COVID-19 shot.

“Junior,” as he is known, is among the cases at the center of the U.S. Food and Drug Administration’s (FDA) internal investigation into pediatric deaths following COVID-19 vaccination.

For his father, Ernest Ramirez, the past four years have been consumed by grief, tireless campaigning and what he describes as a “living hell.”

Now, for the first time, he believes the FDA has acknowledged what he has always known — the vaccine took his child.

“That’s the poison that killed my son,” he told me.

A father fights for his son

Junior was healthy, athletic and inseparable from his dad. Ernest raised him alone.

“We were always together, we were never apart,” he said. “Like I’ve always said, he was my best friend … We were buddies.”

Five days after the Pfizer shot, Junior went to the park with a neighbor to play basketball.

“They started running and he just collapsed,” Ernest said.

Paramedics rushed him to the hospital, but attempts to revive him failed. Ernest still remembers the bluntness of the staff.

“Yeah, you can go home now, your son’s dead,” is how he recalls the doctor’s tone.

He could not return to the empty house.

At first, he had no idea the vaccine could have been involved. It wasn’t until cardiologist Dr. Peter McCullough reviewed the records that Ernest heard the words that changed everything.

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FDA to tighten vaccine rules after memo ties COVID-19 shot to child deaths

The Food and Drug Administration (FDA) is set to implement stricter vaccine approval guidelines after a memo claimed at least 10 children died “after and because of” receiving a COVID-19 shot.

The guidelines, obtained by The New York Times, could also impact vaccinations for other illnesses and viruses, including the FDA’s standards for annual flu shots and if Americans should receive multiple vaccines at a time. The memo also states that shots for pregnant women could be limited, and manufacturers will be required to conduct larger studies before seeking approval for vaccines.

Vinay Prasad, a top vaccine regulator at FDA, said pneumonia vaccine manufacturers must show that their treatments reduce the infection instead of merely developing antibodies to fight it. The new restrictions would also require drug manufacturers to run larger studies that would slow the process of developing vaccines, according to The Washington Post, which also reviewed the memo.

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Shocking FDA Memo Admits COVID Vaccines Linked to Child Deaths

In a bombshell revelation that vindicates long-standing concerns from vaccine skeptics, a top FDA official has admitted that COVID-19 shots are tied to the deaths of at least 10 children.

The admission comes from an internal memo obtained by The New York Times, highlighting the dangers of myocarditis, a serious heart inflammation, caused by the vaccines.

“This is a profound revelation,” Dr. Prasad wrote the memo to staff members, per The Times. “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”

Vinay Prasad, the FDA’s Chief Medical and Scientific Officer and a vocal critic of overreaching COVID mandates, authored the memo.

Prasad described the findings as “a profound revelation” and called for sweeping changes to vaccine approval processes. This includes mandatory randomized controlled studies for every subgroup, ensuring no more rushed authorizations like those seen during the pandemic.

Prasad, an oncologist by training, has long questioned the blanket promotion of vaccines and masks, and his role in the FDA under the current administration marks a shift toward greater scrutiny.

The memo doesn’t detail the ages, underlying health conditions, or specific vaccine brands involved in these tragic cases. However, the Centers for Disease Control and Prevention’s vaccine advisory committee is set to discuss the review in an upcoming meeting, which could lead to further revelations.

FDA Commissioner Marty Makary backed up the memo’s claims during an appearance on Fox News, stating plainly: “There were, it appears, 10 deaths of children from the COVID shots.”

Makary emphasized that the data stems from the Biden administration era, adding that while the vaccines may have benefited high-risk elderly individuals, pushing annual shots on young people “is not based on science.”

This development aligns with actions from Health and Human Services Secretary Robert F. Kennedy Jr., a longtime advocate for vaccine safety who has already restricted COVID vaccines to those 65 and older or with qualifying health conditions.

This reverses the all-out push under previous administrations, including mandates that forced millions, including children, into getting the shots despite emerging risks.

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FDA Chief: Fauci ‘100% Involved” In “Massive” COVID-19 Origins Cover-Up

Food and Drug Administration Commissioner Dr. Marty Makary accused former top health official Dr. Anthony Fauci of orchestrating a “massive cover-up” of the origins of Covid-19. In an interview with “Pod Force One” podcast, Makary said that Fauci, who served as director of the National Institute of Allergy and Infectious Disease during the pandemic, worked to suppress the Wuhan lab-leak theory.

“One thing that’s extremely obvious that very few people realize, and certainly hardly anyone in the medical establishment where I come from realized, is that [Fauci] was involved in a massive cover-up of the origins of COVID, a massive cover-up,” Makary, who previously served as a professor at Johns Hopkins School of Medicine, told host Miranda Devine.

“Whether or not he was involved in the experiments or funding the experiments that led to the origins of COVID, he was clearly 100% involved in the cover-up,” the FDA head added.

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How CDC and FDA Defrauded the American Public about Serious Vaccine Harms

n a fascinating book released in September, Vaccines, Amen. The Religion of Vaccines, lawyer Aaron Siri explains how the American public was systematically misled by the very institutions they are supposed to trust. 

Via numerous lawsuits, Aaron brought many deeply buried, politically inconvenient facts to light, and he is very factual, which is uncommon for vaccine books. They are usually emotional and far too critical of vaccines, or far too positive, with little in-between, which is where the truth is.

The value of lawyers cannot be overestimated. Nothing hurts like the truth about healthcare, which is why we badly need lawyers to dig it out. When drug policy researcher Alan Cassels reviewed my 2025 book, How Merck and Drug Regulators Hid Serious Harms of the HPV Vaccines, he concluded that “If you want the real truth about drugs, don’t ask doctors – ask lawyers.”  

Another quote on my book cover is from Martin Kulldorff, the current chair of the Advisory Committee on Immunization Practices (ACIP) at the US Centers for Disease Control and Prevention (CDC): “Drugs and vaccines can heal and save lives, but also harm. That puts our lives in the hands of pharmaceutical companies. Can we trust them? In this well-documented book, the clear answer is: NO.”

It is essential to understand this. We know very little about the harms of vaccines because most of the data come from substandard and flawed trials performed by drug companies, which leave out important adverse events from their publications and avoid, with virtually no exceptions, to compare their vaccines with a placebo. 

As an expert witness in a lawsuit against Merck, I read 112,452 pages of confidential study reports and uncovered multiple instances of scientific misconduct in which the drug agencies were complicit. It turned out that Gardasil, an HPV vaccine, causes serious and persistent neurological harms, which drug regulators have denied. 

Aaron explains right from the start why vaccines are sacrosanct. People never say they believe in cars but many say they believe in vaccines, without having the data needed to provide an informed opinion. I found the same when I analysed BMJ articles about Kennedy’s much-needed vaccine reforms; it was all about faith, not about science. 

Aaron has used lawsuits to demonstrate that vaccinologists have a self-reinforcing belief system whose dogmas do not stand up to scrutiny in court. His takedown of Stanley Plotkin, the “high priest” of vaccines, during a deposition is a masterpiece in exposing that the emperor has no clothes when claiming that childhood vaccines are safe and have been carefully tested. 

Plotkin was unable to understand why his earnings of hundreds of millions of dollars from royalties and his close alignment with the interests of the industry could influence his views on vaccines. He didn’t know that safety monitoring in certain trials only lasted 4-5 days after vaccination, which is way too short to capture autoimmune adverse events. Worst of all, Plotkin stated that certain vaccines don’t cause certain harms, or he stated that they were rare, without having any evidence in support of his wishful thinking. 

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