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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Covid Porn Is Back

The tireless hacks at the BBC have emerged from their bunkers once again to terrorise the public by bravely touring the hospitals and whipping up hysteria about the latest outbreak of flu. It seems “literally hundreds” of patients have been bombarding A&E departments, according to Health Editor Hugh Pym and Chloe Hayward who have been courageously touring the front line:

As one patient leaves his room at Leicester Royal Infirmary’s acute unit, cleaning staff are waiting outside.

He is barely out of the room before the bed is stripped and bleach is sprayed. The next patient is already waiting to come in.

Over two days the BBC was given access to the hospital to witness first-hand how it is coping with an early surge of winter bug cases.

Flu season has hit a month earlier than normal this year, with experts warning there appears to be a more severe strain of the virus – mutated H3N2 – circulating.

Hospitals around the country, like this one in Leicester, are doing all they can to avoid becoming completely overwhelmed.

“Completely overwhelmed.” Sounds familiar?

They’re at the Royal Infirmary in Leicester, and after citing some choice case studies, miss no opportunity to make it sound like the end of the world is imminent:

“There are patients in every cubicle,” Consultant Saad Jawaid says, as Paige is wheeled in. “Another ambulance has just rocked up.”

We watch as he works with colleagues in the resus unit to find desperately needed bed spaces.

“When beds are full we have to move people – sometimes that means those who can sit are moved out of beds and into chairs,” he says.

Regardless of the situation in the hospital and the range of conditions people are turning up with, on closer examination it things aren’t quite as bad as the story’s florid copy suggests:

Richard Mitchell has been the Chief Executive of University Hospitals Leicester NHS Trust since 2021 – and has witnessed first-hand how it gets harder to cope with each winter that passes.

”We are already seeing very high levels of flu,” he tells us. He expects numbers to climb into January. “That is one of the many things I am concerned about at the moment.

“At this point I feel we are working at the limits of our ability.”

What exactly was he expecting? An idle coast through to April before going on a well-unearned summer break? It raises the interesting question of what people who work for the NHS think they are likely to be confronted with in 21st century Britain.

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The Pandemic Revealed the Most Cowardly Society of All Time

In terms of importance, the Covid-19 pandemic was the biggest event in human history since World War II. Since that time, nothing has caused as much fear across the entire planet as what began in 2020. Because of the widespread terror, with lockdowns we reached the point of completely stopping the world, something that had never happened before in history. As proof, we were left with the frightening and dystopian photos of huge empty metropolises and airplanes parked on the runways of airports.

During the Cold War, with the Cuban Missile Crisis of 1962, when the Soviet Union brought nuclear missiles to Cuba, there was a lot of fear. Some families in the US and Europe even built survival bunkers in their homes. But that didn’t even come close to the worldwide scale of the terror caused by Covid-19.

However, the fear caused by the Cold War—that feeling that the world could end in nuclear explosions at any moment—even though it was more localized and lasted for a shorter time, quickly gave rise, as a positive side, to a formidable culture: the Beatles, revolutionizing music and interpreting the world, emerged from that. 

The Rolling Stones and Pink Floyd came from that fear. At the same time, the miniskirt was invented, the contraceptive pill appeared, and sexual freedoms were conquered. In 1968, known as “the year that never ended,” young people all over the world wanted to be protagonists and took to the streets of cities on every continent. The hippie movement, of peace and love, arose from that brew.

I understand it was a process of liberation, in which the planet’s youth buried that well-fed fear of nuclear war. Everyone was thinking and expressing a loud and revolutionary “We want to live.”

Covid Affected the Elderly Much More

For you to keep reading this article, you need to agree with me on one single point. You need to agree that Covid-19 is a disease that affects the elderly much more than young people and children. After all, the elderly have far more comorbidities, accumulated over a lifetime, than the young. This is extremely basic, and I’m not even going to link to scientific studies that prove this fact.

Sales Strategy

“You vaccinate not only for yourself. You vaccinate also to protect society and particularly to protect those that you love the most,” declared Albert Bourla, CEO of Pfizer, at the 2022 World Economic Forum meeting. That was the main message around the entire world. In Brazil, for example, on every television program the message was identical: “The vaccine protects both you and the people around you,” stated epidemiologist Pedro Hallal, rector of the Federal University of Pelotas, on TV Globo—Brazil’s biggest network—also in early 2022.

What few people know is that this message had been previously studied and tested. Before rolling out the vaccines, Yale scientists conducted research to find out which messages would be most effective in getting people to comply. “It is even more effective to add language that frames vaccine uptake as a way to protect others,” the scientists concluded in the study.

In other words, the entire tone of the vaccination campaign became “Protect grandma.” From that point on, with the widely publicized idea that the Covid-19 vaccines were a social pact, politicians in various parts of the world implemented health passes and, in some cases, made vaccination mandatory for everyone—including children and babies.

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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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Defense Bill Requires Trump Spy Agencies To Declassify COVID-19 Origins Intel, Chinese Obstruction

Slipped into the nearly 3,100-page National Defense Authorization Act (NDAA) is a provision that requires “declassification” and “transparency” related to the origins of the COVID-19 pandemic, and would require the Trump administration’s spy agencies to release its intelligence related to the Wuhan Institute of Virology where COVID research was offshored by the Obama administration in October of 2014 with a grant to EcoHealth Alliance, a New York City nonprofit run by Peter Daszak. 

In March of 2018, Daszak submitted a grant proposal titled Project DEFUSE (short for “Defusing the Threat of Bat-borne Coronaviruses”) to DARPA, which sought to create genetically modified bat coronaviruses with enhanced potential for human infectivity – including features that could enable aerosol (airborne) transmission. The proposal was ultimately rejected by DARPA over safety concerns – however “if funding became available,” then certain components of particular interest could proceed.

So, let’s see if the NDAA passes with this language – and whether it confirms the above Fauci-funded adventures in Wuhan. Of note, Peter Daszak – unlike Fauci – was not pardoned by former President Joe Biden and the infamous autopen. 

The text of the NDAA – specifically section 6803 of the text, calls on the Director of National Intelligence Tulsi Gabbard to work with the heads of all 18 US spy agencies to “perform a declassification review of intelligence” related to “the origins of Coronavirus Disease 2019,” and related to “efforts by government officials of entities of the People’s Republic of China” to cover up the origins of the pandemic. 

“DNI Gabbard remains committed to declassifying COVID-19 information and looks forward to continued work with Congress to share the truth about pandemic-era failures with the American people,” a DNI spokesperson told Just the News.

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Millions Experienced COVID-19 Vaccine Side Effects

More than a third of Americans who were vaccinated against COVID-19 say they had side effects from the shot, and nearly half suspect the vaccines killed many patients,

The latest Rasmussen Reports national telephone and online survey finds that 68% of American Adults say they got a COVID-19 vaccination, and a majority (60%) of vaccinated adults report no side effects from the vaccine. However, 26% say they had minor side effects and 10% reported major side effects from the vaccine. Based on a U.S. adult population of 258 million, this would mean 63 million had at least some side effects from the COVID-19 vaccine, including more than 17 million who experienced major side effects. (To see survey question wording, click here.)

Among all American Adults (including those who didn’t get vaccinated against COVID-19), 46% believe it is likely that side effects of COVID-19 vaccines have caused a significant number of unexplained deaths – down from 55% in September 2024 – including 25% who say it’s Very Likely. Forty-four percent (44%) now don’t think a significant number of deaths have been caused by vaccine side effects, including 20% who believe it’s Not At All Likely. Another 12% are not sure.

The survey of 1,292 American Adults was conducted on November 10-12, 2024 by Rasmussen Reports. The margin of sampling error is +/- 3 percentage points with a 95% level of confidence. Field work for all Rasmussen Reports surveys is conducted by Pulse Opinion Research, LLC. See methodology.

Those who didn’t get the COVID-19 vaccine are more likely to suspect it had deadly side effects. Seventy percent (70%) of those who weren’t vaccinated, compared to 36% of those who did get the shot, consider it at least somewhat likely that side effects of COVID-19 vaccines have caused a significant number of unexplained deaths.

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ANOTHER ONE: Los Angeles County Employees Charged for $700,000 Pandemic Fraud Scheme

The country is already reeling from the massive fraud scandal unfolding in Minneapolis. Now it turns out that there is another huge fraud scandal coming to light in Los Angeles, California.

In this case, Los Angeles County employees were busted for $700,000 in fraud charges that stem from an unemployment scheme.

Isn’t it amazing how many people seem to have a talent for gaming system out of massive piles of cash?

KTLA News reports:

11 Los Angeles County employees charged in over $700,000 pandemic unemployment fraud scheme

Eleven more Los Angeles County employees have been charged with felony grand theft for allegedly stealing unemployment benefits while working full-time during the COVID-19 pandemic, according to the Los Angeles County District Attorney’s Office.

The new charges, announced by the office, follow an earlier round of filings in October against 13 county employees accused of similar conduct. In total, prosecutors say 24 employees fraudulently collected a combined $741,518 in unemployment benefits between 2020 and 2023.

District Attorney Nathan J. Hochman said his office intends to pursue the cases aggressively. “My office will continue relentlessly rooting out fraud and prosecuting government employees who steal from the public they serve,” Hochman said in a statement provided by the District Attorney’s Office. While most county employees “ethically fulfill their duties,” he said, those who “exploit the system and betray the public’s trust” will face prosecution.

More from NBC News in Los Angeles:

Among the newly charged people, several of them worked for the Department of Health Services at the time of the alleged theft.

One employee, Georgette McKinney, a supervising child support specialist for the Child Support Services, stole over $55,000 with her own identity – in addition to stealing over $76,000, using 28 fictitious identities, the district attorney’s office said.

In another case, Jessica Alcorta was charged for stealing over $36,000 in unemployment benefits while working as a legal office support assistant for the district attorney’s office.

“While the vast majority of Los Angeles County employees ethically fulfill their duties and are dedicated to public service, there are some who exploit the system and betray the public’s trust,” District Attorney Nathan Hochman said in a statement. “My message to fraudsters is unequivocal: If you steal from taxpayers, you will be prosecuted.”

If the Trump administration starts actively looking for fraud in blue cities, they’re probably going to find themselves very busy.

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Scientists who advised government during Covid did not reveal they had received more than £200m in grants from one of the world’s biggest pharma investors, report says

Scientific advisors to the Government during the Covid pandemic failed to reveal they received over £200million in grants from one of the world’s biggest pharmaceutical investors, a report reveals.

Twenty-six members of the influential Scientific Advisory Group for Emergencies (SAGE), which helped shape lockdown rules, did not register the research funding from the Wellcome Trust in an apparent conflict of interest.

The report by the campaign group UsForThem analysed research data from The Wellcome Trust, which is largely funded by its investment portfolio and links to the pharmaceutical industry.

It claims the 26 members received at least £210 million in grants from Wellcome between 2018 and 2026 which were not declared on the SAGE register of participants’ interests (Ropi) with £175 million provided during the key Covid years of 2020 and 2021 alone.

Analysis by the Mail on Sunday of publicly-available information shows one grant recipient was Professor Neil Ferguson, one of the biggest advocates for vaccines and whose advice to Prime Minister Boris Johnson led to the UK lockdown in March 2020, and who famously resigned as a government adviser two months later after it emerged he broke rules to meet his married lover.

Prof Ferguson declared in the register that he was involved with a ‘Vaccine Impact Modelling Consortium’, but did not mention Wellcome anywhere.

Yet he was either the lead applicant or sponsored other applications for grants worth £5.6million including a £1.25 million grant looking at influenza-like viruses in Vietnam, according to the analysis of Wellcome’s figures.

Of the 149 SAGE members during the Covid crisis 38 applied for funding or supported other applications to the Wellcome Trust, the UK’s biggest charity.

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Colorado Medical School Will Pay $10.3 Million After Denying Religious Exemptions for COVID Vaccine

The University of Colorado Anschutz School of Medicine will pay more than $10.3 million to 18 faculty and students whose religious exemptions to the school’s mandatory COVID-19 vaccine policy were denied, a group representing the plaintiffs announced Monday.

The lawsuit challenged the university’s refusal to accommodate sincerely held religious objections to the COVID-19 vaccine. The plaintiffs, who sued anonymously, included physicians, medical students, nurses and administrative staff.

The Thomas More Society, which filed the lawsuit and represents clients in religious liberty cases nationwide, stated that the settlement is a rare instance in which plaintiffs recovered monetary damages under the First Amendment for a government COVID-19 vaccine mandate.

Michael McHale, senior counsel at the Thomas More Society, said the resolution cannot undo the harm inflicted on the plaintiffs.

“No amount of compensation or course-correction” can make up for the damage caused by the university’s vaccine mandate, McHale said. “At great, and sometimes career-ending, costs, our heroic clients fought for the First Amendment freedoms of all Americans who were put to the unconscionable choice of their livelihoods or their faith.”

Details of the settlement, which followed more than a year of negotiations, were not released. According to the Thomas More Society, the school agreed to cover damages, tuition and attorneys’ fees.

The settlement ends nearly five years of related litigation in state and federal courts.

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Is President Trump really so concerned about the flow of drugs ‘poisoning Americans,’ when he just pardoned a notorious drug trafficker and warp speeds harmful pharmaceuticals?

Anyone who still believes the Trump administration’s newly scheduled wars in Latin America are in any way related to stopping drugs from killing Americans is not paying attention to the full spectrum of policies coming out of this administration.

Instead of listening to Trump’s many bombastic public statements in a vacuum, let’s examine the record of his actions.

This administration has an obsession with drugs. Even known harmful drugs have been embraced and promoted by President Trump in his first and second terms.

There is now plenty of evidence that Trump’s Operation Warp Speed project, which he placed under the direction of former pharma executive General Gustav Perna and the U.S. military, led to mega-deaths in the United States and the world. Speed came at the cost of any valid clinical trials, with needles entering arms under Emergency Use Authorization with only two months of safety data on the FDA’s books. When it comes to experimental new medicines or treatments, you don’t gamble with people’s lives. There are reasons why it takes 10-15 years to get a vaccine through the approval process, but Trump was willing to make that gamble. And it paid off in the form of record profits for Pfizer and Moderna.

The latest evidence of that was just last week when Trump’s own FDA finally fessed up and told us the Covid shots led to the deaths of at least 10 children during trials (this is based on VAERS data which has been proven to be underreported by a factor of at least 10). This was kept hidden from the American public, along with all the other reams of evidence showing that the shots killed people of all ages and continues to do so.

As a result, hundreds of thousands of Americans report suffering vaccine injuries, as even The New York Times is reporting.

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