Tag: vaccines

Kennedy Ends Covid EUA Declarations, but PREP Act Shield Remains

Seven years after Washington rushed poorly tested drugs, shots, and devices into the fight against a new coronavirus — spending billions and killing and injuring millions in the process — it has finally discovered that the emergency is over.

Well … mostly.

Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. has now moved to terminate the Covid-19 emergency use authorization (EUA) declarations for drugs, biological products, and medical devices.

But as long as the PREP Act shield remains in place, the move looks less like accountability and more like a marketing exercise dressed up as a ceremonial retirement of paperwork.

Terminating EUAs

HHS described the move as a return to normal order.

The agency said the circumstances that justified those emergency authorities for Covid products “no longer exist.”

It also said the Food and Drug Administration (FDA)-approved, cleared, and licensed products are now widely available through ordinary regulatory channels.

Kennedy stated:

By ending these COVID-19 emergency use authorization declarations, we’re reinforcing public confidence that emergency authorities are temporary and targeted.

That sounds like a clean break. It is not.

The termination does not take effect immediately. The declaration for drugs and biological products will terminate 12 months after Kennedy’s determination. The medical device declarations will terminate after 180 days. HHS said the delay will allow manufacturers, healthcare systems, distributors, and patients to move away from products authorized solely under Covid EUA declarations.

In other words, the emergency is over, but only after a courtesy period for the industries that built businesses around it.

The FDA, the agency within HHS responsible for reviewing and regulating drugs, vaccines, biological products, and medical devices, has long treated the Covid EUA structure as separate from the formal public health emergency. When the Covid public health emergency ended in May 2023, FDA said that step did not end existing EUAs. It also said the agency could continue issuing new EUAs if the legal criteria were met.

Kennedy’s action now starts the clock on that separate authority. To understand what that means, it helps to separate the headline from the legal machinery underneath it.

What HHS Actually Terminated

The key phrase is “EUA declarations.”

Kennedy did not simply revoke every Covid product authorization. He terminated the underlying emergency declarations that allowed FDA to issue and maintain EUAs for broad categories of Covid products.

Under federal law, HHS first makes an EUA declaration. FDA then uses that declaration to authorize specific products for emergency use. Those products can include unapproved drugs, biological products, devices, or unapproved uses of approved products. FDA describes EUA authority as a tool for making medical countermeasures available during “chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases.”

Once the HHS secretary terminates the declaration, EUAs based on that declaration generally cease to be in effect. FDA also loses the ability to issue new EUAs under that terminated declaration. The law, however, allows transition periods and certain continued use of products already distributed.

That is the actual legal effect.

It winds down the emergency authorization lane. But it has limits. It does not automatically punish anyone for using that lane. It neither creates liability for injuries nor compensates the injured. And it does not remove products that already moved into traditional approval, clearance, or licensure.

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Moderna’s mRNA Flu Vaccine Gets Unanimous Thumbs-Up Despite Risks, Low Efficacy

A federal advisory committee today unanimously voted to endorse Moderna’s mRNA flu vaccine — just months after rejecting the company’s application on the basis that Moderna had not performed an “adequate and well-controlled” clinical trial.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews scientific data on the safety and effectiveness of vaccines and other therapeutics on behalf of the U.S. Food and Drug Administration (FDA), voted 9-0 in dual votes to recommend approval of the vaccine for the 50-64 and 65-plus age groups.

Today’s votes took place after several hours of presentations based on the findings of Moderna’s Phase 4 clinical trial data for its mRNA-1010 vaccine. The trial compared the efficacy of mRNA-1010 to that of a conventional, non-mRNA flu vaccine.

Daniel O’Connor, founder and CEO of TrialSite News, told The Defender today’s favorable votes “may reflect the committee’s view that the benefit-risk profile is acceptable.” However, the vote “does not erase the fundamental concerns surrounding this application.”

“Significant questions remain about comparator selection, study design and whether the reported efficacy advantage represents a clinically meaningful improvement for patients or simply a statistical advantage within the framework of the trial,” O’Connor said.

According to an FDA briefing document prepared in advance of today’s meeting, “no major deficiencies were identified” with the vaccine for adults 50 and over. Citing the clinical trial data, the document states that the mRNA-1010 vaccine had a 26.6% relative efficacy rate in adults 50 and over, with similar rates for adults 65 and up.

The mRNA-1010 vaccine also showed a higher immune response than Sanofi’s Fluzone vaccine, the document noted. According to Fierce Biotech, these results met all of the FDA’s “pre-specified criteria for success” and bolstered Moderna’s application for approval.

Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said today’s vote shifts mRNA-1010 safety monitoring to after licensure.

“VRBPAC meetings proceed to the beat of the rubber stamp. The unanimous vote guarantees a lot of really good questions of harm will have to be answered in the post-marketing period, when that harm manifests in the population,” Jablonowski said.

Moderna seeks traditional approval for the mRNA-1010 vaccine for the 50-64 age group and accelerated approval for the 65-plus age group.

Fierce Biotech reported that the FDA uses VRBPAC meetings to “seek outside counsel on tough or high-profile regulatory decisions.”

The FDA will make an approval decision on mRNA-1010 by Aug. 5 — and while the agency is not bound to VRBPAC’s votes, it “often follows the opinions” of its advisory committees.

Moderna’s stock was up over 4% in trading immediately after the vote, and up 3.50% at the close of market.

mRNA vaccine had higher rate of adverse events than conventional flu shot

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The Last Nurse Standing

There are court cases that arrive dressed as employment disputes but carry the weight of an era. Adams et al. v. Mass General Brigham is one of them.

On paper, it is a federal discrimination case in Boston involving three remaining plaintiffs, Tyler Adams, Michelle Orfanos, and Jamie Steverman, against Mass General Brigham, the most powerful hospital system in Massachusetts. In reality, it is a post-pandemic reckoning over institutional power, religious liberty, scientific certainty, workplace coercion, and who gets to write the official history of the mandate years.

Mass General Brigham is not some minor regional employer. It is the largest private employer in Massachusetts, a Harvard-affiliated medical empire with tens of thousands of employees and annual revenue measured in the tens of billions. Its own public materials describe the system as having 82,000 employees and $23 billion in annual revenue, while its CEO profile states that Anne Klibanski leads an 85,000-employee system with $22 billion in revenue and $2.7 billion in annual research funding.

In June 2021, MGB announced that all 80,000 employees would be required to receive a COVID-19 vaccine once the FDA granted approval to one of the vaccines. “The evidence of COVID-19 vaccine safety and effectiveness is overwhelming,” Klibanski said in the announcement. Employees, MGB stated, would be able to request medical and religious exemptions.

That promise, that exemptions existed, is where the story begins.

More than 2,400 employees sought exemptions. MGB granted only 234. In a 2023 federal order, Judge F. Dennis Saylor wrote that MGB had “effectively made a determination that some level of risk, eventually involving 234 unvaccinated individuals out of approximately 93,600 employees… was tolerable.”

For the plaintiffs, that fact is not incidental. It is central. Their argument is not that MGB granted no exemptions. Their argument is that MGB granted some exemptions while allegedly denying others through a secretive, discriminatory, and uneven process that favored certain religions and disfavored others.

The most vivid remaining face of that fight is Michelle Orfanos, a registered nurse who had worked for MGB since 2012. According to her state-court complaint, Orfanos worked throughout the pandemic unvaccinated, including as a homecare nurse and as a volunteer in the Boston COVID field hospital. She says she had received religious exemptions to flu vaccines for years, only to have her COVID religious exemption denied in 2021, resulting in her termination.

Then came the second firing.

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HHS Terminates the COVID-19 Emergency Use Authorization Declarations Covering mRNA Shots, Drugs, and Biologics

Today, the U.S. Department of Health and Human Services finally moved to terminate the COVID-19 Emergency Use Authorization (EUA) declarations that have been in place since the early months of the pandemic.

The termination is not immediate. HHS has established a transition period of up to 12 months for EUA drugs and biologics and 180 days for EUA medical devices. According to the agency, the phased wind-down is intended to avoid disruptions and allow manufacturers and healthcare systems time to transition away from the emergency framework.

These declarations formed the legal foundation for the authorization of COVID-19 mRNA injections, monoclonal antibodies, antiviral drugs, diagnostic tests, ventilators, personal protective equipment, and numerous other medical products deployed during the pandemic response.

Unfortunately, the deadly Pfizer and Moderna mRNA injections are already fully FDA approved, meaning this action will have little practical effect on their continued use. The emergency framework that enabled their rapid rollout is finally being dismantled, but the products themselves have already moved beyond it.

While today’s announcement marks the formal beginning of the end of the COVID EUA era, it does not produce the outcome many of us had hoped for, including but not limited to the removal of mRNA products from the market.

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Europe’s Highest Court Rules Against Military Member in COVID Vaccine Mandate Case

A military officer failed to convince Europe’s highest court that Italy’s COVID-19 vaccine mandate for military members discriminated against military members because the mandate didn’t also apply to civilian employees.

The officer, identified by the initials B.G., served in Italy’s Army Engineer Corps. He was suspended without pay in January 2022 for refusing to comply with the mandate.

Earlier this month, the European Court of Justice ruled that opposition to vaccine mandates based on policy disagreement, rather than sincerely held belief, is not protected under European Union (EU) anti-discrimination law.

B.G. challenged his suspension, arguing that regular COVID-19 tests were an acceptable alternative to compulsory vaccination and that workers in other sectors were given this choice.

Italy’s Constitutional Court ruled against him, finding that the military vaccine mandate was an appropriate measure for military personnel.

On appeal, Italy’s Council of State, the country’s highest administrative appeals court, asked the European Court of Justice to clarify several legal questions.

The European Court of Justice found that B.G. did not demonstrate a sincerely held religious, spiritual or philosophical belief protected under EU law.

“Judges found BG was not expressing a protected religious, philosophical or spiritual belief but challenging Italy’s public health policy,” Courthouse News reported. His objections “focused on vaccine effectiveness, possible side effects, testing as an alternative and the way the mandate was implemented.”

In its ruling, the European Court of Justice wrote that B.G. “does not seek to oppose the compulsory vaccination at issue in the main proceedings on the basis of his own beliefs, but to challenge, as such, the choices made by the Italian authorities in the field of public health.”

Those objections “constitute opinions” on public health, and as such, are not protected. Aside from sincerely held beliefs, EU law also protects against discrimination based on age, disability or sexual orientation.

Dutch attorney Meike Terhorst called the ruling “unfortunate and disappointing,” as the legal protection of personal beliefs in the EU “appears to be an empty shell.”

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New Zealand vaccination records show 50% higher-than-expected all-cause mortality after vaccination; Health New Zealand refuses to investigate

I just independently validated Barry Young’s standardized mortality rate (SMR) analysis in my github. I used independent methods and came out with an SMR of 1.5, slightly less than Barry’s numbers (1.65).

In short, people in New Zealand who were vaccinated should be dying at a lower rate than average (SMR <1) due to the healthy vaccinee effect, not at a rate >50% higher than normal.

The refusal to investigate

The fact they are dying at >50% higher than normal rates after their vaccine should trigger Health New Zealand to investigate what is causing the excess deaths.

They refuse to do so. They don’t even want to analyze their own data.

Instead, they are trying to throw their former database administrator, Barry Young, into jail for seven years for exposing the truth about the mortality in New Zealand for those who were vaccinated.

Easy to replicate

Anyone can replicate Barry’s results. It took me only about 15 minutes. All the data is in my github.

An SMR of 1.5 doesn’t mean that the COVID vaccine killed these people. But the health authority refuses to identify what caused the excess deaths. It can’t be COVID because the health authority says that if you get the shots, you can’t get COVID or die from COVID.

And it couldn’t be any of the mitigation measure is recommended by the health authority because we all know that those decrease deaths.

So the excess deaths Barry calculated were all in the vaccinated who were protected against the COVID death.

So why were they dying 50% higher than normal?

Silence from Health New Zealan

It appears that we’re never going to find out the answer to that question because the health authorities are keeping the records under wraps and they refuse to investigate to find the cause of the excess deaths.

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New Study Strongly Links Merck’s Gardasil HPV Vaccine to POTS, but Authors Downplay Signal

A new analysis of adverse events reported to the federal vaccine safety surveillance database after the HPV vaccine detected a strong safety signal for POTS, an autonomic nervous system disorder, in some people who received the shots.

The authors of the study, published last week in PLOS One, analyzed 77,909 reports associated with human papillomavirus (HPV) vaccines submitted to the Vaccine Adverse Event Reporting System (VAERS) between 2006 and 2024.

They concluded that the signal for postural orthostatic tachycardia syndrome (POTS) warranted further investigation. However, they downplayed the significance of their findings, according to experts who spoke with The Defender.

Their discussion section dedicated only two sentences to POTS, even though the condition was the strongest signal identified by the analysis.

The authors underscored that a signal for POTS does not prove that it was caused by the shot, and said that a strong signal “does not necessarily translate into a large clinical or public health impact.”

Warning that when people hear about serious adverse events, it affects their “perception” of safety, the authors framed their paper as part of a process of identifying and addressing potential risks that “is crucial to maintaining high vaccination coverage.”

Cynthia Nevison, Ph.D., said this approach led the authors to be dismissive of their own results. “I always object in principle to papers that start out with the motivation of reducing vaccine hesitancy,” Nevison told The Defender.

Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker said the attempts to downplay POTS as a side effect of the HPV shot are “criminal and the paper is expertly crafted to hide this very obvious signal in order to repeat the default ‘safe and effective’ lie.”

He added that given VAERS underreporting, “we know that the pesky result they’re downplaying could represent 68,000 POTS cases nationwide and over 1 million serious adverse events total.”

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Study Claiming COVID Vaccines Benefit Heart Health ‘Hopelessly Flawed,’ Scientists Say

A new study linking COVID-19 vaccines to a significantly lower risk of heart attack and stroke joins “the latest in a growing body of research about the vaccine’s benefits for heart health,” according to The Washington Post, which reported on the study.

But Dr. Vinay Prasad, a professor of epidemiology and biostatistics at the University of California, San Francisco, called the study “hopelessly flawed.”

Prasad, the former director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research before stepping down in April, and other scientists said the study’s methodological flaws skewed its findings.

“Not only should it not be in the news, the paper should not be in print,” Prasad wrote on Substack.

Canadian researcher Denis Rancourt, Ph.D., called the paper “outright bad science” that “should not be used whatsoever to ‘help inform clinical and public health discussions’ as they propose.”

The study, published last week in JAMA Internal Medicine, tied COVID-19 vaccination to a 37.7% lower risk of serious cardiovascular conditions, particularly among people 75 and older or people with comorbidities.

The authors also found that the vaccinated had a 6.2% lower risk of serious heart conditions overall and a 6.6% reduction in all-cause hospitalizations.

“Extrapolating these estimates to a population of 1 million people, vaccination could plausibly be associated with averting approximately 2370 [major cardiovascular] events and 1580 deaths over an 8-month period,” the study claims.

However, the researchers acknowledged that “the absolute benefit” of COVID-19 vaccination “was modest for the general cohort.”

Heart conditions such as myocarditis are widely associated with the mRNA COVID-19 vaccines, with reports of deaths connected to the vaccines, particularly among teenage and young adult males.

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The Empathy Weapon

This morning the New York Times published an essay by an immunologist who wasn’t vaccinated as a child, found science, got her shots, and now wants to help other parents see the light. It’s got that signature NYT sheen, is well written and emotionally compelling. And yet, if you’ve been paying attention to the media machine you can see that this piece is merely emotional blackmail. It’s sophisticated and speaks in the language of maternal love. The fact that it’s dressed in a lab coat is the tell.

The essay’s argument is simple: the author’s mother didn’t vaccinate her out of love. The author now vaccinates her own children out of love. The only difference is information and emotional support. The moral of the story? Parents who don’t vaccinate aren’t bad people – they just haven’t been guided to the correct conclusion yet.

Anyone not asleep through the last few years may recognize the game.

In 2021, New York’s Governor Kathy Hochul stood before a congregation and told them the vaccinated were “the smart ones,” that those who refused were “not listening to God,” and that the faithful needed to go out as “apostles” and convert the unbelievers. It was cheap, crude, and disgraceful on so many layers.

And then there was Bill de Blasio. In the middle of the city’s vaccine push, the mayor of New York went on camera dangling a plate of burger and fries, moaning “Mmm, vaccination” like he was filming a McDonalds commercial.

I’ve never been more ashamed to be a New Yorker than watching those two represent my hometown during that period.

The Times essay is precisely the same sermon for a different congregation. Three pitches for the exact same product. De Blasio dangled fries at people who couldn’t afford to say no. Hochul played to the soul. The Times aims square at the laptop class. The approach may look different but the reveal is obvious: there is only one correct answer and the institutions hold it. These are all merely tactics to get the holdouts to convert.

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CDC Awards Pfizer $1.24 Billion for COVID Vaccines for Kids and Adults

The roughly $735 million pediatric and $505 million adult COVID-19 vaccine grants cover 2026 and 2027, according to federal records. The monetary infusion has revived debate among critics and public health experts around the safety and efficacy of the vaccines and reliance on mRNA technology.

The Centers for Disease Control and Prevention’s (CDC) recent decision to award Pfizer $1.24 billion for COVID-19 vaccines has renewed debate over the government’s continued investment in mRNA technology.

The contracts, awarded on June 1, include about $735.7 million for pediatric COVID-19 vaccines and nearly $505.3 million for adult doses for fiscal year 2026-2027.

Critics say the funding reflects a continued commitment to vaccines associated with high rates of serious injuries and deaths, and a lack of adequate safety testing and monitoring.

Public health experts argue the investment is necessary to protect vulnerable populations and prepare for future outbreaks.

The latest contracts come as mRNA technology expands beyond COVID-19.

A recent review in Human Vaccines & Immunotherapeutics found that mRNA-based therapeutics were identified in more than 550 registered clinical trials. The authors reported that more than 90% of the projects involved mRNA vaccines and that most products remain in early-stage testing before broader adoption.

‘Unnecessary and often harmful injections’

The procurement of monetary resources signals that federal officials intend to continue investing heavily in mRNA technology despite declining public demand and ongoing controversy over vaccine safety monitoring, critics say.

Jeffrey Tucker, president and founder of the Brownstone Institute, told The Defender there was “no scientific justification” or “market demand” for the latest mRNA vaccine funding.

“This raises a serious question concerning how these captured agencies really work,” Tucker said. “We are talking about vast amounts of tax dollars flowing to support unnecessary and often harmful injections.”

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