FDA slaps damning warnings on COVID-19 vaccines; highlights Biden administration's safety-risk gloss



Federal health authorities rebuked Florida Surgeon General Dr. Joseph Ladapo for suggesting in 2022 that the benefit of COVID-19 vaccination among healthy young men was outweighed by the risk of heart conditions, myocarditis in particular.

Ladapo issued guidance that stated, "Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving a mRNA COVID-19 vaccine."

“Our goal is not to get into like a fight or a tiff, because public health isn’t served well by this,” said Dr. Peter Marks, then-director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research. "Our goal is to help get to … an acceptance that there are overall benefits of these vaccines, despite the fact that yes, it is true that there could be some side effects."

'Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis.'

Marks' former agency has since acknowledged that there is a greater risk of post-vaccination myocarditis than the so-called experts were first willing to publicly admit.

Months after telling both vaccine manufacturers to include new safety information regarding their respective drugs in the stated interest of "radical transparency," the FDA indicated on June 25 that it required Pfizer and Moderna to note the estimated unadjusted incidence of heart conditions following administration of the 2023-2024 formula of the Comirnaty and Spikevax vaccines, as well as the longitudinal results of a 2024 study concerning cardiac manifestations and outcomes of vaccine-associated myocarditis in American youths.

The FDA also required Pfizer and Moderna to describe the new safety information in the adverse reactions section of their vaccine information inserts.

RELATED: How Big Pharma left its mark on woke CDC vax advisory panel — and what RFK Jr. did about it

 Photo illustration by Joe Raedle/Getty Images

For years, the fact sheets for the mRNA COVID-19 vaccines noted that reports of adverse events demonstrated increased risks of myocarditis and pericarditis, particularly following the second dose, and that the "observed risk is highest in males 12 through 17 years of age."

Now, the package inserts state that "the observed risk has been highest in males 12 years through 24 years of age" and:

Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.

The package inserts for both drugs also now state:

Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known. Information is not yet available about potential long-term sequelae of myocarditis or pericarditis following administration of mRNA COVID-19 vaccines.

When discussing the updates, Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, provided a refresher about the effort by the previous administration to downplay the risk of myocarditis.

Prasad, referring to congressional testimony given by Sen. Ron Johnson (R-Wis.) in May, noted that Centers for Disease Control and Prevention and the FDA officials were aware in early 2021 of a safety signal for the heart condition on the basis of Pentagon and Israeli data.

'The FDA's new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science.'

A day after health officials at the agencies acknowledged a safety signal, and after the CDC discussed whether to issue a Health Alert Network message on myocarditis, the Biden White House distributed talking points to top U.S. health officials de-emphasizing the risk.

On May 26, 2021, then-acting FDA Commissioner Janet Woodcock told then-CDC Director Rochelle Walensky that the "FDA does not concur with the issuance of the myocarditis HAN as written."

That day, both agencies reportedly decided to "nix the HAN" alert.

"The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered," Woodcock stated the following month. "The benefits of COVID-19 vaccination continue to outweigh the risks, given the risk of COVID-19 diseases and related, potentially severe, complications."

The nixed alert could have made a difference.

After all, Prasad noted that "in August of 2021, in an FDA regulatory action, we document that based on the health insurance claims Optum dataset, the rate of post-vaccination myocarditis from the Pfizer-BioNTech vaccine was approaching 200 cases per million or approximately 1 in 5,000" among 16- and 17-year-old males.

RELATED: Democrats who locked down America during COVID now cry dictator over Trump's deportations

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FDA Commissioner Martin Makary and Prasad noted in a May article in the New England Journal of Medicine that "the FDA’s new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk."

Blaze News reached out to the FDA but did not immediately receive a response.

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Report: Biden Admin ‘Downplayed’ And ‘Delayed’ Warnings About Covid Shot Risks

'The full extent of the Biden administration’s failure to immediately warn the public about all COVID-19 vaccine adverse events must be completely exposed.'

Exclusive: Sen. Ron Johnson Probes ‘Development’ And ‘Safety’ Of Big Pharma’s Covid Shots

'I expect you to fully comply with this request,' Johnson wrote.

‘Just the tip of the iceberg’: Study uncovers DISTURBING vaccine side effects



Americans who spoke out against the COVID-19 vaccines were painted as conspiracy theorists for the better part of the last four years, but they’re finally being vindicated.

Dr. Peter McCullough, cardiologist and chief scientific officer of the Wellness Company, has been one of those “conspiracy theorists,” but now he has the proof. In a shocking peer-reviewed study that mainstream media outlets won’t touch, a high likelihood of correlation between the COVID-19 vaccine and death was found.

“What we know the vaccines cause, in terms of, you know, their safety warnings and what was determined is that about 74% of all the deaths that have occurred after vaccination that have come to autopsy, in fact, the vaccines caused the death,” McCullough tells Jill Savage and Matthew Peterson of “Blaze News Tonight.”

“The peer-reviewed literature has now about 4,000 papers on fatal and non-fatal vaccines, disabilities, and deaths. So no, it’s not a shock,” he adds.


“When we look at the mRNA vaccines, where do we go from here? Do they have a future? Do you think that they get shut down at this point?” Savage asks.

“There are multiple calls to shut it down, that the platform is not safe, that none of the COVID-19 vaccines are safe for human use. The World Council for Health in the U.K. was the first to call for that, now [from the] Association of American Physicians and Surgeons, Doctors for COVID Ethics — there are now literally dozens of calls for the vaccines to be removed,” McCullough explains.

“I expect they will be taken off the market,” he continues. “Largely, the crisis is closed at this point in time. We can treat residual cases. The vaccines never were compelling.”

However, Peterson notes that studies like the one McCullough is citing are still being censored.

“The censorship in the medical literature is significant. It comes at the editorial reviewers and the publisher level. What’s unprecedented are papers being fully published, contracted, copyrighted, indexed in the National Library of Medicine, and then having them be retracted for no specific reason,” McCullough explains.

“I have been an editor of two major journals in the past, and I can tell you, it’s my estimate that only 1% of these papers are fully getting through and being published. Only 1%. So 4,000 papers describing all these concerning side effects, it’s just the tip of the iceberg,” he adds.

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US Army ADMITS the vaccine hurt soldiers, but no — the Army won’t help them



Karolina Stancik is a U.S. Army veteran who tragically suffered severe heart conditions after being mandated to take the Moderna COVID-19 vaccine.

While the Army has shockingly acknowledged in an internal memo that her injuries were vaccine-induced, they discharged Stancik and refused to cover her medical treatment.

“I am 24 years old, I have had three heart attacks, a mini stroke, and I am now getting a pacemaker,” Stancik told investigative reporter Catherine Herridge in an interview.

Stancik told Herridge that the COVID vaccine is when “everything flipped upside down” for her and that she was “left behind and trampled” by the U.S. Army.

“So, the Army admits in an internal memo that they referenced that all of these injuries were caused by the vaccine, and yet, you know, they discharged her by the way, because ‘You’re of no use to us now. You’re disabled now,’” Sara Gonzales says, clearly disturbed.

“How sick and how rotten is this administration that we will force servicemen and women to buy into a narrative and if they don’t and then get hurt, you just toss them aside and feed them to the wolves,” Jaco Booyens agrees.

Booyens' own brother, who he says has “3% body fat and is a top former professional athlete,” all of a sudden got myocarditis.

“His doctors lie to him, they tell him it’s called ‘athlete’s heart,’” Booyens explains. “He’s like, ‘What is athlete's heart?’”

“Fights for his life in ICU for 13 days, turned to the brink of death. This has happened hundreds of thousands, if not millions of times,” he continues, adding, “Anthony Fauci should be in front of an international tribunal for crimes against humanity.”


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FDA approves new Moderna mRNA vaccine without bothering with independent advisers



The U.S. Food and Drug Administration has approved Moderna's mRNA-1345 vaccine, which allegedly protects adults aged 60 and older from respiratory syncytial virus infection-caused lower respiratory tract disease.

The agency's breakthrough therapy designation approval for the drug, which will be marketed as mResvia, is only the second Moderna drug the FDA has approved. More significantly, it is the first mRNA vaccine to have been approved to address a disease other than COVID-19.

'We did not refer your application to the Vaccines and Related Biological Products Advisory Committee.'

Even though that amounts to a big step, it appears the regulator was keen to jump past additional levels of scrutiny.

The FDA noted in its Friday approval letter, "We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your [biologics license application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion."

The advisory committee's job is to review and evaluate data concerning the "safety, effectiveness, and appropriate use of vaccines and related biological products," then provide independent expert advice to the agency.

According to the pharmaceutical company, the approval was based on "positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 or older in 22 countries."

Nearly 20,000 of the trial participants were based in the United States. There are at least 11 other studies under way examining the impact of the novel drug on other demographics.

The company claimed in a Feb. 29 overview of its trial data that the vaccine "continued to be efficacious through median 8.6 months follow-up" and was shown to prevent severe RSV disease "base on analysis of shortness of breath and medically attended RSV-[lower respiratory tract disease]."

The vaccine's efficacy is allegedly 83.7%. Reuters noted, however, that the label indicates the shot is only 79% effective at preventing at least two symptoms of RSV, such as fever and cough.

While the overview insisted that the vaccine was relatively effective and safe, it nevertheless highlighted a number of "systemic reactions" reported within seven days of vaccination, such as headache, fatigue, myalgia, arthralgia, and chills, besides customary injection site pain.

A Moderna-funded study published in the New England Journal of Medicine similarly alleged that a single dose of the vaccine "resulted in no evident safety concerns."

Despite similarly having been presented as a safe vaccine, Moderna's COVID-19 vaccine was linked in various studies, including in an FDA-funded study, to an increased risk of myocarditis and pericarditis, particularly in men ages 18-25.

Extra to heart inflammation, the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the CDC and the Department of Health and Human Services — revealed in a February study in the esteemed journal Vaccine that "Bell's palsy had an increased [observed to expected] ratio after a first dose of [Pfizer's] BNT162b2 and [Moderna's] mRNA-1273."

The study also noted that "there were also increased OE ratios for febrile seizures following a first and second dose of mRNA-1273 ... and for generalized seizures following first mRNA-1273 dose and fourth BNT162b2 dose."

Blaze News previously reported that the University of Auckland, which hosts the Global Vaccine Data Network, noted that there were safety signals for "acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after viral vector and mRNA vaccines."

Despite outstanding concerns about its only other approved vaccine, Moderna appears confident in its product and has evidently secured the FDA's confidence as well. Its next stop is the Centers for Disease Control and Prevention, whose Advisory Committee on Immunization Practices will review the vaccine during its June 26-27 meeting.

Analysts estimate Moderna will do roughly $340 million in RSV vaccine sales this year and possibly $830.5 million in 2025, reported Reuters.

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Blood clots, neurological disorders, and swollen hearts: Multinational study on COVID vaccines paints a damning picture



Those skeptical of the assertion that COVID-19 vaccines were altogether safe and effective — a claim long advanced by once-trusted government agencies, pharmaceutical companies, and the media amidst a historic censorship campaign targeting dissenters and critics — appear to have had their doubts once again validated.

A damning new peer-reviewed multinational study examining data from nearly 100 million people has not only affirmed the well-documented link between the COVID-19 vaccines and increased risk of heart conditions but has also highlighted troubling links between the AstraZeneca, Moderna, and Pfizer vaccines and medical conditions such as Guillain-Barré syndrome, brain and spinal cord inflammation, Bell's palsy, and convulsions.

The study was conducted by the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the Centers for Disease Control and Prevention and the Department of Health and Human Services — and published last week in the esteemed journal Vaccine, the official journal of the Japanese Society for Vaccinology.

Lead author Kristýna Faksová of the Department of Epidemiology Research at the Danish State's Serum Institute was joined by researchers from various other countries including Argentina, Australia, Canada, Finland, New Zealand, and Scotland in assessing whether there was a greater risk of 13 neurological, blood, and heart-related medical conditions occurring following the receipt of a COVID-19 vaccine.

According to the observed versus expected rates study, which included data on 99 million people vaccinated against SARS-CoV-2 across eight countries, "the risk up to 42 days after vaccination was generally similar to the background risk for the majority of outcomes; however, a few potential safety signals were identified."

"Bell's palsy had an increased OE ratio after a first dose of [Pfizer's] BNT162b2 and [Moderna's] mRNA-1273," said the study. "There were also increased OE ratios for febrile seizures following a first and second dose of mRNA-1273 ... and for generalized seizures following first mRNA-1273 dose and fourth BNT162b2 dose."

The researchers observed a trend of Guillain-Barré syndrome and cerebral venous sinus thrombosis — a type of blood clot in the brain — cases after viral vector vaccines such as the Oxford-AstraZeneca COVID-19 vaccine, which Canada and European nations ditched in spring 2021 over reports of dangerous blood clots.

The researchers specifically found a "statistically significant increase in GBS cases within 42 days after a first ChAdOx1 dose." Whereas they expected to find 76 GBS "events," they found well over twice as many.

The University of Auckland, which hosts the Global Vaccine Data Network, noted that the researchers found possible "safety signals for transverse myelitis (inflammation of part of the spinal cord) after viral vector vaccines and acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after viral vector and mRNA vaccines."

However, the paper cautioned that "although some case reports have suggested a possible association between COVID-19 vaccination and ADEM, there was no consistent pattern in terms of vaccine or timing following vaccination, and larger epidemiological studies have not confirmed any potential association."

The study did however confirm previously established safety signals for myocarditis and pericarditis following mRNA vaccination, highlighting "significantly higher risks of myocarditis following the first, second and third doses of BNT162b2 and mRNA-1273 as well as pericarditis after the first and fourth dose of mRNA-1273, and third dose of ChAdOx1, in the 0–42 days risk period."

According to the study, "Potential underreporting across countries may have led to an underestimation of the significance of potential safety signals" for viral vector and mRNA vaccines alike.

"The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals," Faksová said in a statement. "Single sites or regions are unlikely to have a large enough population to detect very rare signals."

The researchers claimed that the "safety signals identified in this study should be evaluated in the context of their rarity, severity, and clinical relevance."

Additionally, they noted the "overall risk–benefit evaluations of vaccination should take the risk associated with infection into account, as multiple studies demonstrated higher risk of developing the events under study, such as GBS, myocarditis, or ADEM, following SARS-CoV-2 infection than vaccination."

Blaze News reported earlier this month that a peer-reviewed study published Jan. 24 in the Springer Nature Group journal Cureus suggested the COVID-19 vaccines were a rushed product with an "unacceptable harm-to-reward ratio."

The study noted that the kinds of serious adverse events that would be factored into a risk-benefit comparison "have often been wrongly ascribed to COVID-19 rather than to the COVID-19 mRNA vaccinations."

"Misattributions of SAEs to COVID-19 often may be due to the amplification of adverse effects when mRNA injections are followed by SARS-CoV-2 subvariant infection," said the study. "Injuries from the mRNA products overlap with both [post-acute COVID-19 syndrome] and severe acute COVID-19 illness, often obscuring the vaccines' etiologic contributions."

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Study: COVID-19 vaccination is 'strongly associated with a serious adverse safety signal of myocarditis'



The U.S. government, the mainstream media, and so-called experts long downplayed the possibility of a link between heart inflammation and COVID-19 vaccines. Elements of the medical establishment and social media companies worked to shut up those who dared to press the issue.

Health officials and their stenographers in the media later admitted an elevated risk of myocarditis among mRNA COVID-19 vaccinees, especially among boys and young men. Despite belated advisories to this effect from the Food and Drug Administration and the Centers for Disease Control and Prevention, little changed in the way of the prevailing narrative: the supposed benefits of the vaccines outweighed the risks, which allegedly remained mild and rare.

A new peer-reviewed study published Saturday in the pharmacotherapy journal Therapeutic Advances in Drug Safety has thrown some more cold water on that persistent narrative, indicating that "COVID-19 vaccination is strongly associated with a serious adverse safety signal of myocarditis, particularly in children and young adults resulting in hospitalization and death."

"COVID-19 vaccines induce an uncontrolled expression of potentially lethal SARS-CoV-2 spike protein within human cells, have a close temporal relationship of events, and are internally and externally consistent with emerging sources of clinical and peer-reviewed data supporting the conclusion that COVID-19 vaccines are deterministic for myocarditis, including fatal cases," the study claims.

The study is the result of an effort on the part of Texas cardiologist Peter McCullough, biologist Jessica Rose, and researcher Nicolas Hulscher to further explore links between COVID-19 vaccination and heart inflammation using the vaccine adverse events report system.

On the basis of data in VAERS — a system created and implemented by the FDA and CDC in 1990 — the researchers examined the frequency of myocarditis reports in the aftermath of COVID-19 vaccination and compared their findings with past reports from other vaccines that have been rolled out over the years.

The researchers found that upon the massive rollout of the mRNA COVID-19 vaccines in 2021, there was a significant spike in the number of myocarditis reports, "far higher than the reports from all other vaccines combined over the previous 30 years. This side effect was mostly reported in young individuals, especially males."

The spike represented a 2,500% increase in the "absolute number of reports in the first year of the campaign when comparing historical values prior to 2021."

Contrary to governmental claims of mildness, the study found that most of those who reported myocarditis required emergency medical care or hospitalization, and 92 individuals reportedly succumbed to the apparently vaccine-induced affliction.

The study highlighted that the COVID-19 vaccines, which were rushed through safety and efficacy trials inside a 10-month period as opposed the years-long process that novel genetic products customarily undergo, continue to be recommended to everyone 6 months of age and older. The researchers suggested this recommendation should be axed, at the very least for children.

"Children have a negligible risk for COVID-19, and yet they are a high-risk group for myocarditis from COVID-19 vaccination," wrote the researchers. "The World Health Organization's current vaccination advice states that healthy young people ages 6 months to 17 years are a 'low priority group' and that vaccinating this group has limited impact on public health."

The researchers stressed further in their paper that "myocarditis resulting in hospitalization and death attributable to the COVID-19 vaccines may be viewed as an excess risk of the injection program" because, despite claims to the contrary, the vaccines never stopped transmission and there "are no prospective, double-blind, randomized, placebo-controlled trials of COVID-19 injectable products demonstrating reductions in COVID-19 hospitalizations and deaths as primary or secondary endpoints."

"We believe COVID-19 vaccination may pose more harm to children than theoretical benefit. This corroborates actions taken by Sweden, Norway, and Finland in 2021 when health officials suspended the use of Moderna injections in young people due to the detection of safety signals for an increased risk of myocarditis," added the researchers.

Europeans are not the only ones who have spared their children from the novel vaccines. Florida Gov. Ron DeSantis' administration has recommended against COVID-19 vaccination for children and young men since March 2022.

McCullough said of his study, "If vaccines cannot demonstrate acceptable safety profiles or be modified to improve safety, they must be removed from the market. Don't accept 'unavoidable harms' and freedom from liability for the manufacturers. These data demonstrate COVID-19 vaccines are not safe."

Dr. Jordan Peterson responded to the study on X, writing, "I think it's about time to lay some criminal charges." He added in a subsequent message, "This is utterly terrible."

Katy Faust, the head of the children's rights group Them Before Us, tweeted, "The pressure to vaccinate my teenagers was overwhelming. From schools, from doctors, from friends, from public establishments that shut them out. A pox on all the medical professionals who pushed this at the risk of children's lives and long-term health."

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'They never said you won't get COVID!' Howie Mandel challenges RFK Jr. on vaccine efficacy
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'They never said you won't get COVID!' Howie Mandel challenges RFK Jr. on vaccine efficacy



Robert F. Kennedy Jr. had a lively exchange with television host and podcaster Howie Mandel surrounding claims in the media that were made about the efficacy of COVIID-19 vaccines. Mandel argued that the messaging was not as misleading as Kennedy was making it out to be.

On Mandel's "Howie Mandel Does Stuff" podcast, Kennedy attempted explained that the claims that were made after clinical COVID-19 vaccine trials were not transparent.

Mandel acknowledged that there was an at-risk group of obese, ill, or older people who were more likely to need vaccination.

Kennedy described Pfizer's clinical trial.

"The clinical trial study, you had 22,000 people who took the vaccine and 22,000 people got the placebo, and what the result was after six months, they had to hand that data to FDA in order to get the emergency use authorization," Kennedy began. "That data showed that in the vaccine group there was one COVID death of 22,000 people over six months; in the unvaccinated group there were two COVID deaths of 22,000 people, so that allowed the company to tell the public the vaccine is 100% effective."

"That's a misnomer," Mandel quickly replied. "100% effective in as far as ... because I saw people on the news going 'well, I got the vaccine, I still got COVID.' They never said you won't get COVID; they just said that it'll kind of pull back the severity of it."

Kennedy then reiterated, "What they're saying, out of 22,000 people there was one COVID death among the vaccinated and there was two COVID deaths on the unvaccinated 22,000 people, and that allowed them to claim it's 100% effective."

"Effective for what? You can't use the word effective," Mandel exclaimed.

"You remember they kept saying it's 100% effective?" Kennedy asked.

"No, they just said it will negate the severity. ... The word 'effective' didn't say you won't get [it], I never heard 'you won't get COVID,'" Mandel added.

"It's not 100% effective, okay, because if that's the metric, what they really should have been telling us is that to prevent one COVID death, they need to give 22,000 vaccines."

 
\xf0\x9f\x94\xa5 Howie Mandel Tries to Rewrite History on the COVID Vaccine & Immediately Gets Schooled by RFK Jr.\n\nHOWIE: "They never said you won't get COVID"\n\nRFK JR: "I saw a tape yesterday of them all saying it...Can I play it for you?"\n\nHOWIE: "Well, wait wait wait...It doesn't matter\xe2\x80\xa6
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Mandel later summarized his position by explaining that many of the decisions made by the establishment were rushed due to panic.

"I believe a lot of mistakes were made, but we were panicked, and you know, we made decisions based on the amount of information that we had at the moment," he said, adding that guidance evolved as more information came to fruition.

The TV-panel judge also plainly asked Kennedy if he was "anti-vaccine," to which the politician replied, "If you show me a vaccine that was safe and effective, that did what it was supposed to do, I would have no problem with it."


Mandel, a longtime comedian, has continually stepped out of his typical element in recent months to support free speech and open commentary.

In December 2023 Mandel appeared on the popular comedy podcast "Kill Tony" and praised the show for its free speech mentality.

"There's no such thing as political correctness; it's comedy! And now I live in L.A. and it's it's tough. I can't say what I want to say," he explained. "Only you give people a platform to do it right. It's funny, it's raw, [the audience isn't] recording it, you can say anything on this show!" he yelled.

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Uncle Sam’s Making Me Take The Covid Jab To Become An American Citizen

Give me liberty or give me subclinical myocarditis.