Tag: fda

Moderna threatens American jobs after FDA snubs mRNA flu shot, trial looked ‘scientifically lax’

For years before he became director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, epidemiologist Vinay Prasad openly railed against what he perceived as the shoddy design of drug trials and the deference regulators gave them, sending biotech stocks tumbling when Commissioner Marty Makary appointed him.

A vaccine maker that hit the federal jackpot during COVID-19 acted caught off-guard when the former University of California San Francisco medical professor put his gripes into practice, halting its FDA application for a new mRNA flu vaccine based on what he considered weak trial design.

Moderna accused Prasad, who described his predecessor Peter Marks as a “bobblehead” for drug approval, of changing the rules in the middle of the game by refusing to review its biologics license application (BLA) without citing “specific safety or efficacy concerns.”

Prasad’s Feb. 3 “refusal to file” letter – which Moderna posted a week later on its COVID resources page for some reason – says the FDA warned the company before it even started the mRNA flu trial that the proposed design raised red flags.

“CBER does not consider the application to contain a trial ‘adequate and well-controlled’ and the application is therefore, on its’ [sic] face, inadequate for review,” because the control arm “does not reflect the best-available standard of care in the United States at the time of the study,” Prasad said, which was “consistent with FDA’s advice” before the study.

This was just the agency’s “preliminary review of the application and is not indicative of deficiencies that would be identified later,” when the FDA conducts a “substantive review,” Prasad emphasized, implying fresh hurdles for Moderna even if it runs a new trial.

Moderna CEO Stéphane Bancel responded with his own thinly veiled threat against Prasad, who had already left the administration once under assault from populist and corporate conservatives who blasted his avowed support for progressive policies and more regulation before Prasad joined the administration. 

CBER’s decision, which Bancel reiterated “did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” said the billionaire Frenchman, who came to Boston-based Moderna from French diagnostics company BioMerieux.

“We look forward to engaging with CBER to understand the path forward as quickly as possible so that America’s seniors, and those with underlying conditions, continue to have access to American-made innovations,” Bancel said, hinting the company would take jobs overseas if the FDA continued its current trajectory.

Department of Health and Human Services spokesperson Andrew Nixon told Just the News Moderna ignored “very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”

Keep reading

FDA Requires Vaccine Makers to Include Febrile Seizure Warning on Flu Shot Labels

The U.S. Food and Drug Administration (FDA) notified six influenza vaccine manufacturers on Jan. 9, 2026 that they must add a warning about the risk of febrile (fever) seizures to their product information labels, citing newly identified postmarketing safety data. The notices, issued under the FDA’s statutory authority to mandate safety labeling changes, were sent to Sanofi, AstraZeneca, GlaxoSmithKline (GSK), and CSL Seqirus.1

According to the FDA, observational analyses conducted during the 2023–2024 and 2024–2025 influenza seasons identified a statistically significant increase in seizures caused by fevers occurring within one day of vaccination among children aged six months through four years, prompting the agency to conclude the findings constitute “new safety information” requiring disclosure in product labeling. In its notification letter, the FDA stated that the results of the analyses “suggest a causal relationship”—language the agency typically avoids unless compelled by evidence.2

The data suggested an “estimated attributable risk of 21.2 excess febrile seizure episodes per million standard-dose quadrivalent influenza vaccinations” and “an attributable risk of 44.2 excess febrile seizure episodes per million standard doses of trivalent [influenza] vaccinations.”

Risk of Febrile Seizures May Increase After Childhood Vaccinations

The Mayo Clinic website states that in some infants and young children fevers can cause convulsions (seizures). Doctors generally describe “simple” febrile seizures as associated with fevers over 100 F, short-lived and typically harmless, although “complex” febrile seizures can last longer than 15 minutes and occur more than once in a 24-hour period.3

It has been acknowledged in the medical literature that convulsions can include an increased risk of future epilepsy (uncontrolled seizure disorder).4 5 Febrile seizures have also been associated with a spectrum of brain dysfunction and rarely, severe brain injury or death.6 7

Bioengineer Brian Hooker, PhD said he disagrees with febrile seizures being characterized as harmless. He said:

Any seizure is bad, period. Mild’ febrile seizures can double a child’s chance of an epilepsy diagnosis and ‘complex’ febrile seizures—lasting more than 15 minutes —can increase that risk up to 10 times.8

On the topic of febrile seizures and childhood vaccines, Mayo Clinic states:

The risk of febrile seizures may increase after some childhood vaccinations. These include the diphtheria, tetanus and pertussis vaccine and the measles-mumps-rubella vaccine. A child can develop a low-grade fever after a vaccination. The fever, not the vaccine, causes the seizure.9

The U.S. Centers for Disease Control and Prevention (CDC) acknowledges that some vaccines are associated with a higher risk of febrile seizures than others, particularly in infants and young children, and that the risk increases when certain vaccines—such as the influenza, pneumococcal (PCV13), and DTaP vaccines—are administered during the same visit.

The agency also notes that measles-containing vaccines, especially the MMRV (measles, mumps, rubella, and varicella) combination, are associated with a higher risk of febrile seizures than their single-component counterparts, and that these events tend to occur within specific post-vaccination time windows. Still, CDC guidance emphasizes that the overall risk is small, that febrile seizures are typically short-lived and without lasting harm, and that vaccination should continue according to the recommended schedule.10

Keep reading

Powdered whole milk may be culprit in botulism outbreak that sickened dozens of babies

Powdered whole milk used to make ByHeart infant formula could be the source of contamination that led to an outbreak of botulism that sickened dozens of babies.

The Centers for Disease Control and Prevention (CDC) reported the details on Friday.

Powdered whole milk may be culprit in botulism outbreak

What we know:

Testing by the U.S. Food and Drug Administration (FDA) found that bacteria in an unopened can of formula matched a sample from a sick baby — and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company, officials said. 

FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart — and it matched the germ in a finished sample of the company’s formula.

What they’re saying:

A ByHeart official said the finding helps shed light on what has become a “watershed moment” for the company.

“We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula,” said Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer.

What we don’t know:

While these results advance the agency’s understanding of the outbreak, the FDA said the findings are not conclusive, and the investigation continues “to determine the source of the contamination.”

Keep reading

FDA Removes Web Content Saying Cellphones Are Harmless – HHS Launches Study

Without fanfare, the Food and Drug Administration has deleted multiple web pages asserting that cellphones are not dangerous. First reported by the Wall Street Journal, the move comes as the Department of Health and Human Services has begun a new investigation into potential health effects of cellphone radiation.

HHS Secretary Robert F. Kennedy Jr has previously declared that cellphones are causing harms that are not yet fully acknowledged. “There’s cellphone tumors. I’m representing hundreds of people who have cellphone tumors behind the ear. It’s always on the ear that you favor with your cellphone…We have the science,” Kennedy said in a 2023 appearance on the Joe Rogan Experience. “You should never put one next to your head… I put it on speakerphone or use earphones.” 

Responding to a Journal inquiry about the change to the FDA website, HHS spokesman Andrew Nixon said, “The FDA removed webpages with old conclusions about cellphone radiation while HHS undertakes a study on electromagnetic radiation and health research to identify gaps in knowledge, including on new technologies, to ensure safety and efficacy.” 

One of the deleted pages included a passage declaring that “the weight of scientific evidence has not linked exposure to radio frequency energy from cellphone use with any health problems.” There may be more scrubbing of the site to come: The Journal notes that the FDA’s site still has summaries of the deleted pages, but the links redirect to other generalized content about the agency’s regulatory mission. 

Kennedy, who had a career as an environmental litigator, has long engaged on this issue. Kennedy represented people suing phone companies for allegedly causing brain tumors, and won a 2020 case that compelled the Federal Communications Commission to reassess its wireless-radiation regulations. He was also chairman of Children’s Health Defense, which has been involved in litigation over 5G technology, and a case blaming an Idaho man’s cardiac issues on a cellphone tower. He has also pointed to radiation as a prime suspect in the mystery of widespread chronic illnesses among America’s children, “Our children are swimming around in a toxic soup, the Wi-Fi radiation is a lot worse than people think it is…yeah, from your cellphone,” Kennedy told Rogan in 2023.  

Keep reading

FDA Commissioner CONFIRMS Agency Lied About DIETARY FAT for Decades to Benefit Big Pharma Interests — Says Low-Fat Advice Drove Americans to Eat More SUGAR and Suffer Higher HEART ATTACK Rates

Food and Drug Administration (FDA) Commissioner Dr. Marty Makary admitted that for nearly 20 years, the agency’s dietary guidance on fat was not just wrong, it was misleading, triggering a cascade of unhealthy eating habits that have devastated American health.

Speaking at a White House briefing on Wednesday alongside HHS Secretary Robert F. Kennedy Jr., Makary unleashed a scathing indictment of the “medical dogma” that has governed American kitchens since the 1980s.

The Commissioner revealed that the government’s crusade against saturated fats, meat, butter, and eggs, was not only scientifically hollow but directly responsible for the explosion of the chronic disease epidemic.

“For decades, we’ve been fed a corrupt food pyramid that has had a myopic focus on demonizing natural healthy saturated fats, telling you not to eat eggs and steak, and ignoring a giant blind spot: refined carbohydrates, added sugars, ultra-processed food,” said Makary.

“Ironically, they took out the healthy, saturated fat and added sugar, and that was supposed to be healthier. We now have a chronic disease epidemic. The focus on fat has paralleled and ushered in an entire generation of kids with high insulin resistance and levels of inflammation never seen before in the human race.”

On Thursday, Makary doubled down on this new finding, criticizing the long-standing “low-fat” dogma that had led Americans to load up on sugar while avoiding healthy fats.

He suggested the narrative was kept alive, at least in part, to shield powerful corporate interests—including Big Pharma.

Most damning, Makary cited data showing that people who followed low-fat diets actually suffered higher rates of heart attacks than those who consumed healthy fats, directly contradicting decades of so-called “expert” federal nutrition advice.

Keep reading

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.

Keep reading

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.

Keep reading

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