Tag: covid-19

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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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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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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Sen. Rand Paul: ‘Without Question’ Fauci Directed U.S. Funds to Wuhan for Gain-of-Function Research

“Without question” former director of the National Institute of Allergy and Infectious Diseases (NIAID) Anthony Fauci directed U.S. tax dollars to the Wuhan lab in China, Sen. Rand Paul (R-KY) said during an interview on Breitbart News Daily.

Paul discussed the recent announcement from the Office of the Director of National Intelligence (ODNI) that Tulsi Gabbard released a trove of evidence that Fauci lied to Congress and directed U.S. funding for gain-of-function research linked to Big Pharma’s pursuit of “universal vaccines.”

Referring to the 120 biolabs in 30 countries (including Ukraine) for which Gabbard revealed “new evidence of longstanding United States government funding,” Paul said, “What I specifically want to know is what exactly the experiments are, because the establishment, the defenders of Anthony Fauci, said this is just a vaccination program for brucellosis for cows.”

“I don’t know. It seems like there might be more there. Why are we doing this in 30 different countries? Why are we doing this in countries that have wars going on? You know, it’s spread throughout a lot of places that you would think on a normal day would be at risk for some kind of military overthrow or having these pathogens released. So I think the real answer is going to be in the details of what the experiments are,” the senator said.

Paul said Fauci and his allies, however, argue that it is not gain-of-function research.

“People need to realize that this experimentation is so dangerous, and often farmed out to third world countries in obscure places — because here we have more scrutiny, and here people would be going, you know, not only are they torturing beagles, or whatever they do in Tunisia — they may also be doing research with viruses, creating viruses that don’t exist in nature, and then running them through animal models that have human lungs, and training the virus to be more adaptable to humans, which is what we think happened with COVID,” he said, describing these as “incredibly dangerous experiments” that “don’t have any value.”

“We’ve never really produced any kind of vaccine or any treatment from them. And making an animal virus into a human virus is not that hard to do, but we certainly shouldn’t be funding it,” he said.

When asked about the claim that Fauci “directed U.S. taxpayer dollars to gain-of-function research in Wuhan, China,” Paul replied, “Without question, he did.”

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A CIA Senior Official Personally Stopped Analysts From Concluding COVID Came From the Wuhan Lab.

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This is not a theory anymore. It is a documented fact with a paper trail.

When CIA analysts were privately concluding in the earliest days of the pandemic that the furin cleavage site in the COVID virus looked consistent with gain of function modification, a senior official at the CIA’s Weapons and Counterproliferation Mission Center personally intervened to stop them from shifting to a lab leak finding.

Not bureaucratic inertia. Not competing evidence. A person. Making a decision. To stop the conclusion the evidence was pointing toward.

On June 4th 2021 that same CIA center briefed Fauci on classified COVID origins intelligence from the President’s Daily Brief. During that briefing Fauci steered the agency toward consulting scientists who had publicly advocated for a natural origin. The scientists he recommended were the ones who had already staked out the position he needed them to hold.

Meanwhile a pre-pandemic Department of Energy warning to Fauci’s own agency about the risks of the Wuhan Institute of Virology research apparently never reached the analysts tasked with investigating the virus’s origin. The people investigating whether the lab caused the pandemic were never told their own government had already flagged that lab as dangerous before the pandemic started.

Then when a whistleblower filed a formal complaint alleging that classified intelligence contradicted Fauci’s sworn testimony to Congress, the Biden DNI’s office routed it not to an independent inspector general but to HHS Secretary Becerra, Fauci’s own boss, who had already indicated the matter was considered.

The FBI told Congress it had interviewed a key witness before reaching its lab leak conclusion. ODNI’s own records show that interview happened months after the FBI had already made its call. And when finally interviewed the witness said nothing about COVID origins at all.

This is not incompetence. Incompetence is random. This is a pattern running in one direction consistently protecting one man from accountability for five years.

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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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Rand Paul Issues Subpoena Forcing Fauci to Testify Under Oath

Sen. Rand Paul (R-Ky.) on Monday subpoenaed Dr. Anthony Fauci to testify publicly next month before the U.S. Senate, after Fauci backed out of a voluntary appearance.

Fauci will have to testify before the Senate Committee on Homeland Security & Governmental Affairs, which Paul chairs.

“Today, I have issued a subpoena requiring him to testify before the Committee, in public, next month,” Paul wrote in a post on X on Monday.

An inside source with knowledge of Paul’s plans told The Defender on condition of anonymity that Fauci is expected to testify under oath about “everything” — from his involvement in funding gain-of-function research that may have created COVID-19 to the subsequent cover-up of a possible lab leak.

In an interview with Semafor, Paul said he will also ask Fauci about the destruction of federal records and about the preemptive pardon former President Joe Biden granted him last year.

The pardon shields Fauci from federal prosecution for his official acts dating back to 2014.

“He’s been slow-walking information to us for six months or more,” Paul told Semafor. “We’ve been negotiating over the date for several months. He agreed, then he said he wouldn’t. So, I think it’s time that we bring him in. I think there’s a lot to discuss.”

Speaking to CNBC’s “Squawk Box” today, Paul credited U.S. Health Secretary Robert F. Kennedy Jr. for aiding in Paul’s COVID-19 origins investigation.

“We’ve gotten more evidence over the last year. From the Biden administration, they revealed nothing. From the Trump administration, particularly with Secretary Kennedy, we’ve gotten a lot of information,” Paul said.

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