Tag: fda

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.

Keep reading

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.

Keep reading

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.

Keep reading

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.

Keep reading

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.

Keep reading

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.

Keep reading

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.

Keep reading

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. 

Keep reading

True scale of America’s mutant meat scandal sparks alarm in government

Advisers to Robert F Kennedy Jr. fear cloned meat and animal breeding could become a divisive issue inside the Make America Healthy Again movement.

The Daily Mail understands that the use of cloned animals in the US food supply is seen as a ‘complex problem’ among Kennedy allies.

The topic gained renewed attention this week when Canada announced it would allow cloned meat products to be sold in supermarkets without any disclosure – a practice the US has quietly permitted for nearly two decades.

Some close allies of the health secretary worry the issue could spark tensions within the movement, particularly among its tech-forward members who align with Elon Musk and view cloned breeding as a potentially valuable tool for boosting sustainability and environmental outcomes, the Daily Mail understands.

For now, the Trump Administration’s Health Department (HHS) has taken no official stance on cloned-animal products in the food supply. 

Sources close to Kennedy say the department is not ruling out weighing in later on what they describe as an ‘interesting issue.’ 

HHS is currently deferring all policy authority to the Food and Drug Administration (FDA), which sits under Kennedy’s leadership.

Keep reading

More High Blood Pressure Drugs Recalled Due to Potential Carcinogens, FDA Says

The Food and Drug Administration confirmed in several notices that a recall of a type of high blood pressure medication has been expanded due to the presence of a potentially carcinogenic substance.

In three noticesissued this week, the FDA confirmed that 7,198 cartons of prazosin hydrochloride are being recalled nationwide by Ohio-based Amerisource Health Services and classified the recall as Class II.

N-nitroso prazosin, a nitrosamine found in the medication, is above the FDA’s acceptable limits, according to the FDA. Nitrosamines are a type of organic compound that is a potential human carcinogen that can form in food or other substances.

A Class II recall is considered by the FDA to be a serious but less severe product safety recall for a product that may cause temporary or medically reversible adverse health consequences or if there is a remote chance of a serious adverse health consequence associated with the item.

Latest Drugs Under Recall

The three items are:

  • Prazosin Hydrochloride capsules USP in 1-milligram doses in 100-capsule (10×10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-996-01, and it has individual unit doses of NDC 68084-996-11.
  • Prazosin Hydrochloride capsules USP in 2-milligram doses in 100-capsule (10×10) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 68084-997-01, and it has individual unit doses of NDC 68084-997-11.
  • Prazosin Hydrochloride capsules USP in 5-milligram doses in 20-capsule (5×4) cartons, which are distributed by American Health Packaging. It has a Carton NDC of 60687-572-32, and it has individual unit doses of NDC 60687-572-33.

The FDA did not include any other information about the recalled items, including whether people should continue taking them. In numerous previous recalls for products that contain elevated nitrosamine levels, the FDA has generally advised people to continue taking the prescription medication.

Keep reading