Tag: vaccines

FDA Directs COVID-19 Vaccine Makers to Expand Heart Inflammation Warning

The Food and Drug Administration (FDA) has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21.

The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis.

Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance, said that new information has emerged, including a 2024 FDA study that found that some myocarditis patients had signs of heart scarring months after vaccination.

The companies must update labels to state that following administration of the 2023–2024 versions of the vaccines, “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” Forshee said. The highest estimated incidence of the post-vaccination inflammation is about 38 cases per million doses for both vaccines, according to the proposed update.

The current warnings say that the highest observed risk after Moderna vaccination is in males aged 18 to 24 and that the highest risk after Pfizer-BioNTech vaccination is in males aged 12 to 17.

The companies were also directed to add new information summarizing the FDA study, including that “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 updates should also state that “it is not known if these heart MRI findings might predict long-term heart effects of myocarditis,” according to the letters.

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Another “Conspiracy Theory” PROVEN TRUE about mRNA CLOT SHOTS reveals tricked human cells keep producing DEADLY SPIKE PRIONS indefinitely

We called it at the beginning, when Big Pharma and the CDC were lying through their teeth, claiming that the mRNA “technology” would only have your cells create spike proteins for a short amount of time, just long enough for your immune system to create antibodies, and then end the production of the virus-mimicking prions. Big fat lie.

First off, the prions don’t just remain at the site of injection. That was a lie. The spike protein prions spread throughout the vascular system, invade the cleansing organs, the brain and the ovaries, and use light to join together to form white, rubbery clots that drive all-cause mortality rates to skyrocket.

Clot shots altered the injected humanoids to be walking prion factories who are dying of all-cause mortality that all boils back to the mRNA Trojan Horse “technology”

Millions of nanoparticles are created by tricked cells for indefinite periods of time, possibly forever, and the injected humanoids around the globe are suffering mass health detriment. That’s right, Moderna and Pfizer clot shots hijack the immune cells, rewrite your DNA and RNA, and prolong spike protein prion production POSSIBLY FOREVER, in the shortened life of the billions of gene-altered humans who succumbed to the plandemic scam. What a shame.

A groundbreaking study published in Nature has upended long-standing assurances from health authorities that mRNA COVID-19 vaccines quickly degrade in the body. Instead, the research reveals that Pfizer and Moderna shots reprogram immune cells to extend their genetic instructions, forcing prolonged spike protein production — contrary to official claims that effects would last only “a few weeks.” The findings, led by Polish researchers (Krawczyk et al., 2025), expose a hidden mechanism that could have serious long-term health implications, raising urgent questions about safety, transparency, and regulatory oversight.

The study found that immune cells, particularly macrophages, activate an enzyme called TENT5A in response to mRNA vaccines. This enzyme rewrites the vaccine’s genetic code, doubling the length of its poly(A) tail — a molecular timer that determines how long mRNA survives. In some cases, Moderna’s mRNA tail extended from 100 to 200 nucleotides, drastically prolonging spike protein production.

“This wasn’t just persistence—it was amplification,” said Dr. Peter McCullough, a cardiologist and vaccine safety advocate. “The body is essentially tricked into editing the shot’s instructions to make it last longer. This was never part of the clinical trials.”

Public health officials, including CDC advisor Dr. Paul Offit, previously asserted that spike protein production would last only “a couple of weeks.” Yet studies have since detected spike protein in blood samples for up to 709 days post-injection. Moderna’s own 2024 internal documents acknowledged “unacceptable toxicity” risks, yet regulators fast-tracked the shots without addressing these concerns.

Molecular biologist Dr. Jessica Rose likened the process to “giving someone a self-replicating memo. The memo was supposed to be read once and discarded. Instead, the recipient photocopies it endlessly.”

Unlike mRNA vaccines, Novavax’s protein-based shot — which delivers pre-made spike protein — does not trigger TENT5A activity. Immunologist Dr. Byram Bridle explained, “The lipid nanoparticles in Pfizer and Moderna’s shots are the Trojan horse. They smuggle synthetic mRNA into cells, but the payload doesn’t just fade away — it gets enhanced by the immune system.”

The Nature study challenges the foundational safety claims of mRNA vaccines, revealing a mechanism that could lead to prolonged spike protein exposure and unknown health risks. With mounting evidence of regulatory oversights and undisclosed dangers, the findings demand urgent scrutiny. As the scientific community grapples with these revelations, millions who received the shots now face unanswered questions about their long-term well-being. The era of blind trust in rushed medical interventions may be over—but for many, the consequences are just beginning.

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US officials delayed warning public about heart inflammation risk from COVID shot: report

U.S. health officials knew about the risks of myocarditis from COVID-19 vaccines but downplayed the concern and delayed informing the public about the risks of taking the jab — that is according to a new Senate report released by Sen. Ron Johnson Wednesday.  

Johnson, R-Wis., chairman of the Senate Permanent Subcommittee on Investigations, has been investigating the safety and efficacy of the COVID-19 vaccines. Earlier this year, he subpoenaed the Department of Health and Human Services (HHS) for records relating to COVID-19 vaccine safety data and communications about the pandemic. 

The interim report, spanning 55 pages, obtained and reviewed by Fox News Digital, revealed that Biden administration officials “withheld crucial health information from the Subcommittee and the public.” 

Since 2021, Johnson has sent more than 70 oversight letters, which he says were “either completely ignored or inadequately addressed.” 

The report highlights the records Johnson has obtained pursuant to the subpoena from the new, Trump administration-led health agency. Specifically, the report focuses on HHS’ awareness of and response to cases of myocarditis—a type of heart inflammation—following COVID-19 vaccination.

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The First Step on the Covid Shots

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is holding a very important meeting on May 22, 2025. Under consideration at this meeting is the fate of the Covid booster shots. There has been considerable anticipation as well as media claims that current recommendations and authorization for these products’ use, particularly in children and pregnant women, may be discontinued. 

Public comments are currently being solicited for the meeting, and wide public interest surrounds this event. Unfortunately, I have received reports from colleagues that some comments submitted to the committee calling for discontinuation of these vaccines have disappeared from the FDA website.

Furthermore, an important article from the FDA published today in the New England Journal of Medicine acknowledges the huge discrepancies in Covid vaccine recommendations in the US vs. other countries – as I describe in detail below. The article hints yet again at possible changes in official recommendations regarding the Covid vaccines. In terms of actual changes, however, none have yet been made official 

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FDA plans to require clinical trials before approving annual COVID vax boosters for healthy people

Food and Drug Administration plans to require new clinical trials before approving annual COVID-19 vaccine boosters for healthy Americans under 65 years old.

The plan appears in a paper published Tuesday in the New England Journal of Medicine, in which FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s vaccine chief, wrote any new COVID shot must undergo placebo-controlled clinical trials, NBC News reported. 

This means that the release of updated COVID vaccines for healthy children and adults this fall will likely be delayed.

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The Covid-19 Crisis: How Political Meddling Threatens Your Health and Medical Freedom.

Doctors who successfully used early COVID-19 treatments like ivermectin faced severe backlash and censorship from medical and government authorities

Hospitals repeatedly blocked effective interventions, putting patients at unnecessary risk by ignoring treatments that could have prevented severe illness

Over 38,000 deaths linked to COVID shots were reported in the Vaccine Adverse Event Reporting System (VAERS), yet health authorities downplayed these numbers

Health care professionals experienced threats to their medical licenses simply for advocating patient-centered treatments and sharing honest clinical results

Taking control of your medical freedom means knowing your rights, documenting your decisions, and actively choosing doctors who prioritize your health over politics

Trust in hospitals and health institutions is sharply declining because of how the health care industry has handled the COVID-19 pandemic. From forced treatments to draconic lockdown mandates, people all over the world suffered greatly. Even doctors who figured out effective treatments that helped save lives were vilified for spreading “misinformation.”

One such case is Dr. Mary Talley Bowden, a Texas-based physician who has treated COVID-19 patients during the height of the pandemic. During her time working in a hospital setting, she observed firsthand how patients recovered quickly using treatments such as ivermectin and monoclonal antibodies. All of this, and more, was discussed in her interview with Tucker Carlson featured above.

Why Vaccine Safety Suddenly Became a Political Battlefield

Getting vaccinated was once viewed as a straightforward part of health care. You’d go your doctor, get your shot, and move on with life, confident you’d done the right thing for your health. While many have criticized vaccinations and their adverse effects on human health, the arrival of the SARS-CoV-2 virus put the entire field under the watchful eyes of the public.

Now, getting the shot isn’t just a health care choice — it’s deeply entwined with politics. Doctors who tried treating their patients with methods outside the official rules faced intense backlash. Bowden shares her side of the story:

• Early treatment is crucial — Using drugs like ivermectin and monoclonal antibodies, she successfully helped thousands of patients recover quickly and fully. Recounting her experience in 2021:

“[M]onoclonal antibodies came about, and those worked great. I mean, I could get as many doses I wanted. I’d get them the next day. I’d just contact the manufacturer, say, I need 200 doses to be at my doorstep. Great. They worked wonderfully. People turned around very quickly.”

• Authorities pushed back against treatments that worked — One reason is that these early treatments undermined the vaccine-focused public health strategy. Powerful organizations insisted vaccines were the only real solution, dismissing alternatives. If patients could recover fully without the vaccine, fewer people would rush to get vaccinated, and Big Pharma wouldn’t like that.

“So this is following the rollout of the COVID shots. The government is upset because people are not buying it. People are not getting them. There’s very low uptake, very low interest. There’s suspicion of these shots,” Bowden says.

“So in March, they started their PR campaign. The government, they went after ivermectin. The FDA put something on their website about, you can’t use ivermectin for COVID. Biden doled out $11.5 billion to groups around the country. Initially, it started with 275.

It went up to 17,000 influencers, church groups, sports leagues, all sorts of people just funneling out taxpayer money to go after doctors like myself that were spreading ‘misinformation’ and to push people to get these COVID shots.”

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Texas House OKs Bill To Sue Vaccine Makers for False Ads

In a major victory for accountability and informed consent, the Texas House of Representatives passed HB 3441 yesterday, a bill that would allow Texans to sue vaccine manufacturers whose advertising leads to injury or harm.

The unprecedented move comes as CDC data show there have been an alarming 2,665,796 adverse events linked to vaccines since 1990, the vast majority related to COVID-19 jabs.

But if fewer than 1% of adverse events are reported – as a 2010 HHS-funded Harvard analysis confirms – the real number could exceed 266 million, or roughly 7.6 million per year, or 20,800 per day.

First filed in February, the new bill passed yesterday by a vote of 88–31, moving the legislation one step closer to becoming law.

The pioneering legislation boasts a whopping 79 brave sponsors, 74 Republicans and 5 Democrats.

The bill is spearheaded by Representatives Shelley Luther (R-62), Jeff Leach (R-67), Marc LaHood (R-121), Oscar Longoria (D-35), and Mike Schofield (R-132).

If you want this kind of bill passed in your state or at the federal level, you can find your local, state, and U.S. representatives here and let them know.

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The FDA Just Approved Another COVID Vaccine — But RFK Jr. Has Already Intervened

The Food and Drug Administration (FDA) on Friday approved the Novavax COVID-19 vaccine, but RFK Jr. is stepping in to limit its avaliability.

The latest Novavax vaccine will only be avaliable to the elderly and those over the age of 12 with an underlying medical condition.

The approval of the vaccine, named Nuvaxovid, is contingent on the company conducting studies to assess potential links to various heart conditions.

However, Some of these investigations can be carried out using existing data sources.

The New York Times has more details:

Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans.

The F.D.A.’s decision appeared to render at least part of their discussion moot.

The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.

The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.

The jab is said to have fewer side effects than mRNA based vaccines because it is built on a more traditional vaccine platform.

Figures in the scientific establishment are already complaining about the restrictrions.

”This is incredibly disappointing,”said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital nd former adviser to the C.D.C.

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Jim Jordan probes politics of Pfizer COVID vax trial as research suggests jabs hurt fertility

The political pressures around clinical trials for COVID-19 vaccines in the 2020 presidential campaign first drew scrutiny from Democrats, with then-nominees Joe Biden and Kamala Harris spreading mistrust of Operation Warp Speed and suggesting they would avoid jabs developed in the Trump administration.

The parties largely switched sides in the Biden administration, with then-Vice President Harris claiming it was “starting from scratch” on a vaccine strategy and even mandating vaccinations for her own campaign employees once she replaced Biden at the top of the 2024 ticket.

Yet Republicans have continued claiming Operation Warp Speed saved millions of lives based on modeling studies, amid five years of global research on severe adverse events in certain groups following COVID vaccination, from heart inflammation to neurological disorders, and the jabs’ mediocre-to-negative performance against infection.

House Judiciary Committee GOP leaders seized on new evidence Thursday that Pfizer withheld what it considered positive trial results until after the 2020 election, with the result that President Trump couldn’t take credit for a finished vaccine, giving Republicans something to unite around amid internal divisions over the pace of reversing Biden’s COVID vaccine policies.

The Department of Health and Human Services is reportedly planning to stop recommending routine COVID vaccines for pregnant women, teens and children, more than 100 days into the Trump administration and after new peer-reviewed research suggests COVID vaccines worsen fertility and mRNA jabs specifically can produce spike protein for up to eight months.

Yet another peer-reviewed study this year, published in the Endocrine Society’s Journal of Clinical Endocrinology and Metabolism, found the risk of underactive thyroid “significantly increased from 6 to 12 months” after vaccination, and that both under- and overactive thyroid was “significantly elevated at 12 months” for mRNA vaccine recipients specifically.

The Taiwanese researchers “used a huge database, carefully matched vaccinated and unvaccinated patients, and followed outcomes for a full year,” former New York Times drug industry reporter Alex Berenson wrote. “That combination gave the study very strong statistical power, meaning that its findings are probably not the result of chance.”

“25,000 children a day are getting the latest version of the mRNA shot,” Texas doctor Mary Talley Bowden, an early victim of COVID treatment policing whose litigation prompted the FDA to stop demonizing ivermectin on social media, wrote on X Friday.

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FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process

The U.S. Food and Drug Administration (FDA) is preparing to issue new guidance for vaccine manufacturers in the coming days as part of a new “radical framework.” The guidance will likely focus on the COVID-19 shots, The Washington Post reported Thursday, citing comments by FDA Commissioner Marty Makary earlier this week.

The Post published its story earlier Thursday, before The Wall Street Journal reported that unnamed sources at the U.S. Department of Health and Human Services (HHS) said HHS is expected to announce within days that it will no longer recommend COVID-19 shots for children, teens and pregnant women.

Speaking at the Food & Drug Law Institute’s conference in Washington, Makary gave few specifics about the upcoming new framework but said it will help ensure the pharmaceutical industry understands “exactly what we’re thinking,” Endpoints News reported.

According to the Post, this may entail “guidance to companies so that they know the agency’s approach to vaccine approvals.”

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry, ‘How is this going to be received?’” Makary said at the conference.

The announcement comes just a month before government regulators are set to review COVID-19 vaccines for the next cold and flu season.

James Lyon-Weiler, Ph.D., president and CEO of the Institute for Pure and Applied Knowledge and editor-in-chief of the journal Science, Public Health Policy & the Law, said the new framework is “long overdue” and “may represent an inflection point — if it goes beyond mere optics and addresses the core systemic failures that have plagued vaccine policy for decades.”

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