Leaked FDA Memo Shows Feds Masked Sudden Cardiac Deaths in Our Children Says Senator Ron Johnson

Senator Ron Johnson raised concerns during an exchange with Robert F. Kennedy Jr. regarding a memo he said originated from a senior official within the Food and Drug Administration, describing findings tied to child deaths following COVID-19 mRNA vaccinations.

Johnson said the memo was “apparently from CBER director, Doctor Prasad,” and referenced its contents as part of an FDA review.

He stated the document described an internal analysis involving “96 autopsies of child death following the covid mRNA injection.”

According to Johnson, the memo included language he described as significant in acknowledging outcomes tied to the vaccines.

“In that memo, Doctor Persad writes, this is a profound revelation,” Johnson said.

He continued, “For the first time, the US FDA will acknowledge that covid 19 vaccines killed American children, healthy young children who face tremendously low risk of death.”

Johnson added that these children were “coerced at the behest of the Biden administration via school and work mandates to receive a vaccine that could result in death.”

Johnson said the memo raised questions about the impact of pandemic-era mandates. “In many cases, such mandates were harmful,” he said.

Keep reading

Elon Musk Reveals COVID Vaccine Injury After Former Pfizer Official Admits Shots Likely Killed Tens of Thousands in Germany

In an X post that went viral Sunday, Elon Musk said he “felt like I was dying” and almost went to the hospital after taking his second COVID-19 vaccine.

Musk was responding to an X post about how Dr. Helmut Sterz, Pfizer’s former chief toxicologist, admitted last month during a German COVID-19 Inquiry that an estimated 60,000 people have died in Germany from Pfizer’s mRNA COVID-19 vaccine, Comirnaty.

According to Sterz, the Paul Ehrlich Institute, Germany’s regulatory and research institute for vaccines and biomedicines, has received 2,133 reports of death following Pfizer’s COVID-19 vaccine.

He said, “These spontaneous reports likely have a high number of unreported cases due to underreporting. The true number is therefore much higher.”

“In the U.S., it is assumed that there is an underreporting factor of 30 by which the registered cases would have to be multiplied. For Germany, this would correspond to 60,000 deaths from the vaccination,” Sterz said.

Sterz told the German commissioners that Pfizer’s post-marketing report mentioned 1,200 suspected deaths within just two months of the shot’s approval.

“At that point, Comirnaty should have been withdrawn from the market,” Sterz said.

Pfizer skipped key safety studies due to ‘time constraints’

Sterz also testified that “due to time constraints,” Pfizer didn’t conduct vital safety checks on its COVID-19 vaccine before rolling it out to the public. For instance, the vaccine maker skipped carcinogenicity studies that would have examined whether the shots had cancer-causing properties.

Pfizer also failed to study the vaccine’s impact on pregnancy.

Sterz called for a new and independent scientific review of the COVID-19 vaccines’ long-term effects. “We need proper independent safety studies to understand what really happened. Without full transparency, people will not trust the conclusions,” he said, according to GB News.

He said the high number of negative side effects associated with the vaccines warrants pausing them, and other vaccines that use similar technology, until independent studies show they are safe.

Keep reading

MHRA study on covid vaccine injuries: The numbers buried inside it deserved rather more attention

One in seven. That is the proportion of people in the MHRA’s own actively recruited surveillance cohort who reported a medically serious adverse reaction following covid vaccination. Over half reported at least one reaction of any kind. The data were collected between 2020 and 2022. They were not published until September 2025, and only then because Cheryl Grainger, through a Freedom of Information  (“FoI”) request and subsequent Information Commissioner’s Office (“ICO”) appeal, forced it out.

The paper that eventually appeared, in the journal Drug Safety, was not written as a safety paper. It was written as a description of the digital platform used to collect the data – a methods paper published five months after Dame June Raine left as chief executive, nearly three years after the data were locked. The actual adverse reaction rates are reported but not analysed. The one stratification that could determine whether those rates are real was not performed.

The numbers buried inside it deserved rather more attention.

What the Data Show

The Yellow Card Vaccine Monitor (“YCVM”) was the MHRA’s premium data source. It was one of four pillars of its covid vaccine safety surveillance strategy. Unlike the passive Yellow Card scheme, where people report voluntarily and sporadically, the YCVM actively recruited people and followed them up at set intervals. The MHRA itself described it as a tool to “rapidly detect, confirm, characterise and quantify new risks.”

Of the 30,281 individuals who reported receiving a vaccination, 15,764 (52.1%) reported at least one adverse reaction. 4,134 (13.7%) reported a reaction classified as medically serious under the MedDRA system. This is a regulatory classification that includes events deemed medically significant by an internal MHRA panel and is broader than the lay meaning of “serious,” but not a trivial threshold. It encompasses hospitalisation, disability, life-threatening outcomes and death, but also other events judged clinically important.

However, the 13.7% might include people who volunteered for the monitor becausethey had been injured. The MHRA did not exclude people signing up afterthey had their vaccine.

The key question is how representative this cohort was. Any voluntary cohort, even an actively recruited one, may over-represent people who experienced problems. Other active surveillance systems internationally have reported lower rates, though none has been free of similar methodological limitations. The true rate is unknown – which is precisely the problem.

The YCVM was meant to be designed to quantify risk in a way passive surveillance could not because of reporting bias. However, the key simple analysis to enable interpretation was not done. The question is not whether 13.7% is the true rate of serious harm. The question is why the MHRA did not do the work to find out what the true rate is.

The Cohort It Did Not Analyse

The paper reports 35.6% registered before vaccination and 47.5% after. A further group registered on the same day, but the paper does not quantify it. Even allowing for this, the categories as presented account for only 83.1% of the cohort, leaving 16.9%, over 5,000 people, unclassified. The paper does not explain the gap.

The pre-vaccination and same-day registrants are the key group. They signed up before or at the point of vaccination, not in response to a bad reaction. Their data is substantially less vulnerable to post-event selection bias, which is the main challenge to the headline figures. The criticism that people with bad reactions were more motivated to register does not apply to them. They were already in the system.

The obvious analytical step is to separate these registrants and compare their Adverse Drug Reaction (“ADR”) rates to those who registered afterwards. If the prospective cohort shows substantially lower rates, the selection bias interpretation is supported and you would want to say so. If the rates are similar, the overall figures are validated and you would want to say that too. If the rates are lower, then that is the rate that is of interest and should be published. In any case, the comparison is critical and should have been presented.

The MHRA did not present the comparison. In a 21-page paper with 13 tables, this stratification – the single most important analysis for interpreting the headline findings – does not appear. I have submitted an FoI request for this data.

Keep reading

Possible Link Between RSV Vaccine During Pregnancy and Health Problems: Study

Pfizer’s vaccine against respiratory syncytial virus (RSV) may be associated with certain health problems in pregnant women, including hypertensive disorders, researchers said in a study published on April 21.

Ashley Michnick, a research scientist at Harvard Medical School, and researchers with Pfizer and other entities analyzed data from five systems, including CVS Health and Kaiser Permanente Northwest.

They analyzed pregnancies that occurred from Sept. 22, 2023, through Aug. 9, 2024, and found that pregnant mothers received Pfizer’s vaccine between 32 and 36 weeks of gestation. The number of included pregnancies was 13,619.

Compared with pregnant women who received a different vaccine, such as an influenza shot, during the same gestational weeks during the study period, the women who received the RSV vaccine were more likely to have pregnancy-associated hypertensive disorders, such as inpatient gestational hypertension.

The risk was also higher when the RSV vaccine recipients were compared with women who had given birth in previous years, or a historical comparator group.

The researchers also recorded an elevated risk for premature rupture of membranes among RSV vaccine recipients.

Keep reading

A Reckoning Is Underway At The FDA

For months, a quiet battle has been unfolding inside the US Food and Drug Administration (FDA).

It began with an analysis of child deaths after Covid vaccination, followed by strategic leaks to major media outlets, and has now erupted into the open with a memo from the regulator’s own vaccine chief.

In September, it was reported that FDA officials had privately investigated 25 paediatric deaths following Covid vaccination — the first systematic review of such cases since the rollout began.

The findings were meant to be presented to the CDC’s Advisory Committee on Immunization Practices (ACIP). But the presentation never came. The meeting passed without a word. Something had happened behind closed doors.

Now we know what.

On 13 November 2025, STAT published an extraordinary insider account describing a tense internal meeting in which FDA scientist Dr Tracy Beth Høeg presented evidence of young people who had died after Covid vaccination.

According to STAT, her findings triggered pushback from career FDA regulators who feared the implications of acknowledging fatal cases.

Now, comes the explosive memo from FDA vaccine chief Dr Vinay Prasad, confirming — for the first time — that US regulators have formally attributed at least 10 of these children’s deaths to Covid vaccination.

Prasad called it “a profound revelation” with far-reaching implications for American vaccine policy, adding that the true number is “certainly an underestimate.”

Here, I’ll take you through the memo, the leaks, the internal rebellion at FDA, and what this means — not just for Covid vaccines, but for all vaccine approvals going forward.

This story marks a turning point in US vaccine regulation.

Keep reading

Canadian gov’t admits it kept data on COVID jab deaths from public over ‘privacy’ concerns

The Canadian federal government has tacitly admitted that key death data relating to the mRNA-based COVID injections were withheld from public reporting, citing supposed privacy concerns.

The Public Health Agency of Canada is defending its decision to withhold the data relating to how those who received the COVID shots and died as a result were tracked.

The revelations come from Conservative MP Dean Allison’s Order Paper Question Q-849. The health agency said it did not publish weekly COVID death counts, as connected to one’s jab status. The agency claimed the numbers were low and posed “privacy” risks.

Because of this, Canadians were denied key information which could have better informed them on the risks associated with the COVID shots, which were heavily promoted at all levels of government.

The Public Health Agency said it tracked COVID jab outcomes from the start, in December of 2020, when the shots were officially approved. This means that the raw data of those who died or were injured following the COVID shots should exist.

Canada’s public health officials claimed that the December 2020 date provided a “consistent starting point” for tracking jabs.

Despite this, the agency instead chose to showcase statistical modelling, through the federal COVID-19 Epidemiology and Surveillance Division, when comparing non-vaccinated people to those who had taken the jabs.

The agency claimed that it followed the World Health Organization and U.S. public health authorities’ guidance models, instead of utilizing and sharing Canada-specific data.

Canada’s government continues to purchase the COVID shots, although its own data show that most Canadians are refusing a COVID booster injection.

Canada’s Public Health Agency (PHAC) recently took over the nation’s vaccine injury compensation program, changing the name from the Vaccine Injury Support Program (VISP) to the Vaccine Impact Assistance Program (VIAP). The agency had admitted the COVID shots have caused harm to no less than 10,000 people.

Keep reading

FOIA Data Reveal Adverse Event Patterns in New RNA Dog Vaccine

Details from a FOIA request to the USDA have revealed severe adverse events following injection of the Nobivac NXT canine flu H3N2 vaccine, the first self-amplifying RNA (saRNA) vaccine widely used in the US for pets. The aftermarket reports received by The HighWire show the first 1,012 pages of 1,888 total pages of adverse events from September 2024 through July 2025. There were 296 cases involving the Nobivac RNA vaccine as a suspect product: 152 were adverse reactions, and 76 were listed as cases of lack of efficacy, meaning the dogs developed respiratory illness or cough after receiving the vaccine.

The dataset shows that there were four canine deaths and one feline death following vaccine administration, but two of the dog cases had significant confounding factors. The other two cases involve dogs that collapsed shortly after receiving the vaccination. In addition, three dogs were euthanized following the vaccine.

-41 cases involved neurological issues

-30 cases of anaphylaxis or hypersensitivity

-52 cases involved vomiting

-19 cases had an injection-site mass/lump/panniculitis/fibrosis/surgery

-26 cases of diarrhea

-5 cases of collapse/shock-type presentations

-4 cases of bloody diarrhea

A 4-year-old golden retriever collapsed 10 minutes after the vaccination, before going into complete cardiac arrest and dying. Merck added anaphylaxis to the report later. A 7-year-old Yorkshire Terrier collapsed 70 minutes after receiving the vaccine, and life-saving care was attempted, but the dog passed away. Diphenhydramine and dexamethasone sodium phosphate were given to the terrier because of previous unspecified vaccine reactions. In addition to the Nobivac flu shot, the 7.33-pound terrier received the Nobivac Canine 1-DAPPvL4 and Nobivac Intra-Trac3 vaccines.

An 8-year-old Shih Tzu was lethargic and vomiting shortly after receiving the vaccination. She was diagnosed with renal failure six days later and euthanized. The event narrative explains that she had received several vaccinations before, including non-Nobivac flu vaccines, but had never received the Nobivac NXT canine influenza vaccine, which is the first approved saRNA vaccine in the country. Merck evaluated this case and said the vaccine was unlikely to be the cause.

saRNA vaccines have limited long-term safety data, much as mRNA vaccines did before they were rolled out to the general public in response to the COVID-19 pandemic. These vaccines are marketed as “innovative, adjuvant-free, non-live vaccines” by Merck.

The first vaccine of its kind was approved by the USDA in 2024 and received limited coverage, but Nicolas Hulscher, MPH of the McCullough Foundation, criticized the lack of safety testing and the manufacturer’s level of transparency.

“It appears that Merck is attempting to camouflage the fact that this product is self-amplifying,” Hulscher wrote. “The primary product description only indicates that it uses ‘revolutionary RNA particle technology.’ However, the novel platform works by RNA particles targeting dendritic cells, where they self-replicate and result in sustained antigen production.“

Keep reading

Biden FDA Knew About COVID Vaccine Stroke Risk And Kept Americans In The Dark

Senate investigators spent months reviewing roughly 2,000 pages of federal records. What they found is damning. FDA and CDC officials under the Biden administration identified a significant stroke risk tied to Pfizer’s COVID-19 bivalent booster in seniors – and never breathed a word to the public.

Sen. Ron Johnson (R-WI), chairman of the Senate’s Permanent Subcommittee on Investigations, sent a formal letter to HHS Secretary Robert F. Kennedy Jr. laying out the evidence. He wasn’t speculating. He was citing the government’s own files.

“HHS records show that as early as October 2022, federal health officials identified a potential connection between the Pfizer-BioNTech COVID-19 bivalent booster and ischemic stroke for individuals over the age of 65,” Johnson wrote.

An ischemic stroke means a blockage of blood to the brain. Between November 2022 and March 2023, seven separate analyses of incoming data flagged the same stroke signal — specifically in adults over 65. CDC data cited by Johnson shows 226 stroke cases reported between August 2022 and February 2023, with additional cases surfacing throughout 2023 and 2024.

Despite the risk, the Biden administration issued no formal warnings. No Health Alert Network message. No changes to booster recommendations for seniors. Nothing.

Instead, in February 2023, HHS quietly hired a private contractor, Lukos LLC, to conduct a deeper internal investigation, dubbed “The Stroke Project.” Publicly, officials kept insisting the vaccines were safe.

“From the initial detection of the safety signal in late 2022 … health officials continued to say the vaccine was safe while simultaneously searching for evidence to support that assertion,” Johnson said.

It gets worse. Federal officials drafted a communications plan about the stroke risk that included a “Tough Questions and Answers” section prepared for President-ish Biden and his White House team. During final edits, the description of the stroke signal was quietly changed from “moderately elevated” to “slightly elevated.” Who made that change? Nobody knows. The language softened, the edit went unattributed, and the public remained in the dark.

The pattern is consistent. Senate investigators previously established that Biden officials also downplayed the risk of vaccine-induced myocarditis and kept that from the public. This wasn’t a one-time failure. It was a system.

Here’s what makes this cover-up even more infuriating. The Biden administration showed it was more than willing to pull the plug on a vaccine when it wanted to. 

Keep reading

A Critique of the “17 Million Deaths Caused by the Vaccines” Claim

I am a physician-epidemiologist who has consistently questioned the safety and efficacy of the COVID-19 vaccines. In the summer of 2021, I was the lead author on the first major study pointing out the risks of post-Pfizer vaccination myocarditis in adolescents. We found that the potential benefits of full vaccination did not appear to outweigh the risks in healthy adolescent males just looking at post-vaccination myocarditis risks alone. Not long after, I was senior author of another analysis published in BMJ-Journal of Medical Ethics that found the harms of the booster dose in college age students likely outweighed potential benefits by at least 18-fold. What is more, I have written multiple times about the COVID-19 vaccines being implicated in numerous deaths and have a related peer-reviewed paper hopefully coming soon. Finally, I have most recently voiced my concern about the production process of the Pfizer mRNA vaccine and the potential risks of DNA plasmid contamination to the Public Health Integrity Committee.

But if you want to bring attention to safety issues with the mRNA vaccines or other pharmaceutical products, using biased publications or prematurely jumping to conclusions is not the way to do it. We can’t complain about the pharmaceutical industry publishing biased research if we turn around and promote equally, if not more biased research about vaccine side-effects. Not only do we need scientists who are not captured by pharma, we need scientists who are not captured in general – by any ideology. We need scientists who are critical thinkers and can acknowledge limitations in data and identify inappropriate methods and causal inference.

Furthermore, avoiding inappropriately scaring people – be it about Covid or the vaccines – is good public health.

17 million deaths due to the vaccines?

Bret Weinstein (in his fascinating interview) on Tucker Carlson said he “saw a credible estimate of 17 million [deaths] globally from this technology”, meaning the vaccines. Now, this was a bit confusing since they were discussing mRNA vaccines at this moment and it was unclear if he meant all types of Covid vaccines. But I immediately thought: 1) Woah… what percent of vaccinated people would have died and how many people would that mean would have died in little, highly-vaccinated Denmark? (For those who don’t know, I am a Danish citizen). Then I thought: 2) What confounded dataset did he use to get this estimate?

But I also want to point out I found it interesting Bret did not give any sort of range in terms of potential numbers of people killed, how this estimate was arrived at or what kind of residual uncertainty there was about the estimate. 

To answer the second question so you are not scrolling ahead, I quickly learned Bret was referring to this analysis by Rancourt, Baudin, Hickey and Mercier, J.: ‘COVID-19 vaccine-associated mortality in the Southern Hemisphere.’

Keep reading

The CDC Was Ordered to Prove the DTaP Vaccine Didn’t Cause Autism… but Their Only Study Showed it Did

For decades, the question of whether vaccines are linked to autism has remained one of the most contentious and widely debated issues in public health.

While major health agencies have maintained that vaccines are safe, critics have continued to scrutinize the data, pointing to gaps, unanswered questions, and the historical record of how these concerns were first investigated.

A video circulating online features attorney Aaron Siri discussing the historical roots of vaccine-related debates, focusing specifically on the pertussis vaccine rather than the more commonly cited MMR vaccine.

According to the caption, Siri traces the issue back to the 1986 National Childhood Vaccine Injury Act, which directed the Secretary of Health and Human Services to study a list of injuries that had been frequently reported in connection with the pertussis vaccine. Among those listed for investigation was autism.

In the clip, Siri describes how the Institute of Medicine (IOM) was tasked with reviewing available research on the topic. He notes that in 1991, the IOM concluded it could not determine whether the pertussis vaccine caused or did not cause autism due to a lack of sufficient studies.

He then points to a later review commissioned by the CDC and HRSA in 2012, stating that the IOM reached a similar conclusion after examining the broader body of scientific literature.

According to Siri, the IOM reported that it could not find studies demonstrating that the pertussis vaccine does not cause autism, and that the only study identified showing an association was ultimately excluded because it did not include an unvaccinated comparison group.

Keep reading