When genomic scientist Kevin McKernan discovered excessive levels of residual DNA in mRNA Covid vaccines, it sparked one of the fiercest safety debates of the pandemic.

Regulators insisted the fragments were present only in trace amounts and posed no biological risk, while critics warned they could potentially trigger autoimmune diseases or integrate into the human genome and contribute to cancer.

But the row overshadowed a far broader problem.

mRNA vaccines are not the only products made using recombinant DNA technology. Manufacturers also use it to produce vaccines against hepatitis B, human papillomavirus, shingles and influenza, as well as monoclonal antibodies given to infants to prevent RSV.

All of these products can carry residual DNA from the manufacturing process, yet fundamental questions about what happens to those fragments after injection remain largely unanswered.

This years-long investigation—built on internal company documents, regulatory filings, court records, and scientific interviews—points to a deeper issue.

Residual DNA may not be just a benign impurity. It can have adjuvant activity, stimulating the immune response and potentially boosting a vaccine’s efficacy.

Consequently, removing the impurity might also compromise its performance—a dilemma that may prove to be the vaccine industry’s dirty little secret.

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When emergency physician Joseph Fraiman’s children were born, he made a decision that would surprise most in his field.

He opted out of the routine vitamin K injection recommended for all newborns to prevent vitamin K deficiency bleeding (VKDB)—a rare but potentially fatal condition.

Fraiman understands the danger better than most. Years spent caring for critically ill patients mean he knows how catastrophic severe bleeding can be, and he accepts that a single intramuscular shot reduces that risk.

His perspective comes as refusal rates for the routine vitamin K injection have risen in recent years.

So why would a doctor trained to manage medical emergencies say no to a preventive treatment for his own children?

For Fraiman, it came down to a simple calculation of absolute benefit, potential harm, and fully informed consent.

Understanding risk

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In a dramatic blow to Moderna, the CDC has left the company’s newly approved mRNA flu vaccine off its list of options for the upcoming flu season.

The snub comes barely a month after the FDA licensed mFLUSIVA for adults aged 50 and older, and weeks after MD Reports first exposed a statistically significant safety signal in its pivotal trial.

Instead of issuing new influenza vaccine recommendations for 2026–27, the CDC has fallen back on last year’s guidance.

Following repeated, unanswered inquiries from MD Reports about its next steps, the agency quietly updated its official website this month, stating that “because of legal uncertainties and inquiries,” last July’s recommendations would remain in effect for the upcoming influenza season.

The CDC has not retreated from flu vaccination. It still recommends an annual influenza vaccine for everyone aged six months and older, with rare exceptions.

For people under 65, it states there is no preference among three vaccine types — inactivated, recombinant or live attenuated influenza vaccines.

For those aged 65 and older, it preferentially recommends Fluzone High-Dose, Flublok Recombinant or Fluad Adjuvanted — and if none is available, another age-appropriate influenza vaccine should be given.

Moderna’s mFLUSIVA vaccine is conspicuously absent.

That omission does not appear to strip the product of its Vaccine Act liability protections. The government’s website, updated last month, says the Vaccine Injury Compensation Program covers “all seasonal influenza vaccines.”

Even so, the setback is significant for Moderna.

mFLUSIVA was the flagship expansion of its platform into seasonal influenza. It now enters the market without a product-specific CDC recommendation, amid mounting political and regulatory scrutiny of mRNA technology.

The vaccine’s FDA approval was mired in controversy last month after MD Reports revealed a statistically significant excess of serious adverse events in Moderna’s pivotal Phase III trial, compared with the conventional flu-vaccine arm at six months.

The FDA nevertheless described these serious adverse events as “balanced,” accepting Moderna’s pooled analysis of four disparate Phase III trials, which diluted the statistically significant imbalance seen in the pivotal study.

The stakes extend well beyond Moderna. Other manufacturers have invested heavily in mRNA influenza vaccines that could ultimately face the same roadblock at the CDC.

On 1 September, GSK announced it was advancing its own mRNA seasonal flu candidate into a Phase III efficacy trial after receiving FDA’s Fast Track designation in July.

Pfizer’s first-generation candidate was a flop in older adults, but the company has not abandoned the technology, launching a Phase II trial in February to test six experimental mRNA influenza vaccines against licensed flu shots.

How the CDC handles mFLUSIVA could set a precedent for the entire pipeline behind it.

This marks one of the first major decisions by new CDC Director Erica Schwartz since being sworn in by Health Secretary Robert F. Kennedy Jr. earlier this month.

Schwartz immediately faced a difficult question — would she step around the CDC’s vaccine advisory committee, ACIP, and issue a recommendation for mFLUSIVA herself?

The committee has been unable to act since a federal court froze the appointments of 13 members in March.

Her decision to leave the existing recommendations in place provides the clearest answer yet that CDC’s new leadership is not stepping around ACIP.

Until ACIP returns, new vaccine recommendations appear to be on hold.

Note: CDC has also yet to issue guidance for the newly approved 2026–27 Covid vaccines.

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Under its long-serving editor-in-chief Dr Gregory Poland, the journal Vaccine built a strong reputation as the flagship publication in vaccinology.

It published papers that did not always align with prevailing views on vaccines, provided they met rigorous scientific standards.

A clear example came in 2022, when Vaccine published Fraiman and colleagues’ analysis of serious adverse events in the pivotal Pfizer and Moderna Covid-19 vaccine trials.

The paper concluded that the excess risk of serious adverse events exceeded the reduction in Covid-19 hospitalisations observed in the trials. It sparked international debate and remains widely cited.

This is exactly what scientific journals should do: provide a platform where evidence and competing interpretations can be openly challenged.

Poland himself embodied that approach. After developing persistent and debilitating tinnitus following his own Covid-19 vaccination, he did not become an opponent of vaccination.

Instead, he argued that vaccine injuries warranted serious scientific investigation and that patients reporting adverse events deserved to be heard rather than dismissed. His stance emphasised nuance over ideological certainty.

That standard appears to have shifted under the journal’s new leadership.

In January 2025, virologist Angela Rasmussen was appointed as one of the journal’s three editors-in-chief.

Outside the journal, Rasmussen has cultivated a prominent and highly combative public profile through X and her Substack. Her criticism has extended well beyond scientific disagreement.

After the reconstitution of the US Advisory Committee on Immunisation Practices (ACIP) in June 2025, Rasmussen described the committee as a “viper’s nest of anti-vax quacks.”

She accused members of “lying about the evidence,” referred to them as “monsters,” labelled them “conspiracy-addled lunatics,” and described aspects of their work as an “incompetent shitshow.”

These were not private remarks.

They were public statements made by an editor-in-chief of one of the world’s leading vaccine journals about scientists serving on the United States’ principal federal vaccine advisory committee.

Editors are entitled to hold strong opinions.

But scientific journals derive their authority from the expectation that editors will evaluate competing evidence impartially, regardless of their own views. The appearance of impartiality matters as much as the reality.

On their own, Rasmussen’s comments might simply be dismissed as a lack of restraint. But they take on greater significance when viewed alongside the journal’s editorial direction.

In the months that followed, Vaccine published two editorials sharply critical of ACIP, echoing the sentiment of Rasmussen’s public rhetoric.

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Back when I was an investigative reporter at the ABC, I researched and filmed a documentary about antidepressants.

The premise was hardly radical.

I was investigating whether the drugs were being prescribed too widely, especially among children, and there was evidence that in a small number of people the drugs could trigger akathisia, severe agitation, suicidal thoughts and aggression.

One of the women I interviewed had a story I have never forgotten.

She was a 33-year-old mother of two from Western Australia who had tried to kill herself and her daughters, aged nine and two — not once, but twice.

On the first attempt she drove them to a car park and attached a hose to the exhaust of the family car. The hose twisted and the attempt failed.

Later that day she tried again, in another parking bay, and left the engine running for 15 minutes before her nine-year-old daughter managed to open the car door.

That is how they survived.

There is no sanitising what happened. Two little girls came terrifyingly close to being killed by their own mother, who had been taking antidepressants.

Her case later appeared in a paper in PLoS Medicine by psychiatrist David Healy and colleagues, examining a possible relationship between antidepressants and violence.

She had first been prescribed the SSRI paroxetine. The dose was increased from 20mg to 30mg. She became more anxious and agitated and was switched to venlafaxine, which was raised to 300mg a day.

Healy and colleagues reported that her records documented increasing anxiety and agitation during those increases—but her clinical notes did not link the deterioration to the medication.

Then came the attempts to kill herself and her children.

When the case reached sentencing in the Supreme Court of Western Australia in 2004, the authors reported that the judge found there were “substantial grounds for implicating venlafaxine” in her behaviour. She received a suspended sentence.

Healy and colleagues concluded that the case appeared to involve treatment-induced akathisia.

“Restlessness” does not come close to describing akathisia.

People who have experienced it describe an unbearable inner agitation, a feeling of wanting to crawl out of their own skin, an inability to escape their own mind.

Some describe it almost as an out-of-body experience—a terrifying sense that they are no longer themselves. Severe cases have been associated with self-harm and suicidality.

I thought the public deserved to know that. But the ABC disagreed.

For two years the TV network actively suppressed the documentary, then decided it would never air. I was told the subject was too controversial and the risk of people stopping their medications was too great.

Kennedy tried to raise the issue

In 2025, Robert F. Kennedy Jr raised the possibility of a relationship between antidepressants and school shootings, calling for more research. He did not claim the drugs caused all school shootings. He said the relationship should be studied.

But that was enough to provoke outrage.

A group of US legislators accused him of promoting “disproven and outright false theories” about psychiatric medications and warned that it would stigmatise people with mental-health issues and discourage them from seeking help.

But there is already evidence that some antidepressants can cause precisely the kinds of behavioural disturbances that make the question worth investigating.

What the trials found

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MIT professor Retsef Levi has publicly accused scientific journals of censoring research into vaccine injuries, after his latest Covid vaccine safety study was rejected by both a leading medical journal and a preprint server.

“We must counter the immense censorship by scientific journals on any discussion of vaccine injuries!” Levi posted on X.

As previously reported, Levi’s study, co-authored with MIT researcher Nelson Lu, analysed responses from nearly 10 million participants in the CDC’s V-SAFE surveillance system and identified a potential safety signal that the researchers say warrants further investigation.

But before the study appeared as a preprint on Research Square, Levi and Lu struggled to get it through the scientific publishing system.

Their experience mirrors that of others trying to publish research on post-vaccination health outcomes

Emails obtained exclusively by MD Reports reveal what happened behind the scenes.

The researchers first submitted the paper to medRxiv, a preprint server established to disseminate health-science research before formal peer review.

It was rejected.

“We cannot verify aspects of the manuscript and feel it would be better disseminated after peer review,” medRxiv told the researchers.

Puzzled by the response, Levi asked medRxiv to identify the specific concerns preventing publication, pointing out that the analysis relied entirely on publicly available V-SAFE data.

medRxiv responded that it lacked “the resources to perform extensive content verification beyond our standard screening procedures,” yet failed to explain what about the study required such verification in the first place.

When Levi pressed again, medRxiv explained that submissions undergo a “two-step screening process” involving affiliate scientists, but stressed that this did not constitute full peer review.

Left without a specific scientific or methodological reason for the rejection, or even the identities of the affiliate scientists who had screened their paper, Levi eventually published the study on a different preprint server, Research Square.

Levi and Lu then turned to the peer-reviewed literature.

Rejected without peer review

They submitted the study to Vaccine, a specialist scientific journal that has published extensively on vaccine safety.

The editors issued a “desk rejection,” turning it down before peer reviewers ever saw it.

The journal explained that it receives far more papers than it can publish, forcing it to select those judged to have the “highest potential impact” while maintaining editorial balance.

The rejection correspondence reviewed by MD Reports identified no specific methodological or scientific problems with the paper.

Levi wrote back.

“I am admittedly very surprised to receive this desk rejection, particularly because Vaccine has published multiple CDC studies on the same V-SAFE data, including one very recently,” he said.

“The rejection without even sending it to referees gives the perception that Vaccine publishes some scientific findings and censors others.”

Open to alternative explanations, Levi asked the journal to clarify its reasoning, but received no response.

Same database, different outcome

Levi’s comparison is striking. Just weeks earlier, Vaccine had published a CDC study analysing the exact same V-SAFE database.

Published online on 30 June 2026, it examined reports from almost 10 million V-SAFE participants through to June 2023.

But unlike Levi and Lu’s study, the CDC’s findings were largely reassuring.

Emergency care and hospitalisation following vaccination were reported infrequently, which the authors noted was consistent with previous V-SAFE analyses and clinical trials.

Levi and Lu, however, asked a fundamentally different question.

Focusing on reports of prolonged health deterioration, they found that 185,285 participants—1.87%—reported worse health lasting at least three months that they attributed to Covid vaccination.

They argued that this finding represented a potential safety signal requiring further investigation.

Although both studies examined the same surveillance system and roughly the same number of participants, they produced very different findings — and had very different experiences in the publishing system.

The peer-review problem

Levi and Lu are not the only researchers studying reports of vaccine injuries after Covid vaccination whose work remains outside the peer-reviewed literature.

Researchers at Yale have been studying such cases through the university’s LISTEN study.

In November 2023, they posted an analysis on medRxiv describing 241 adults who self-reported what the authors called “post-vaccination syndrome,” or PVS.

Participants reported persistent symptoms including exercise intolerance, excessive fatigue, numbness, brain fog, and neuropathy.

Nearly three years later, that study remains a preprint.

In 2025, Yale researchers published a second preprint comparing 42 people reporting PVS with 22 healthy controls. They identified differences in immune profiles, more frequent evidence of recent Epstein-Barr virus reactivation, and elevated levels of circulating spike protein in the PVS group.

That study also remains a preprint.

There is, however, an interesting contrast.

Both Yale studies passed medRxiv’s “screening process,” whereas Levi and Lu’s did not.

One key distinction is that Harlan Krumholz, a co-author of the Yale research, is also a co-founder of medRxiv and serves on the board of openRxiv, which oversees the preprint server.

Why bother with peer-review?

For all its limitations, peer review remains an important marker of legitimacy in medical publishing. Research that has not passed through the process can readily be dismissed as “only a preprint.”

This creates a particular problem for controversial research.

Studies can become trapped in scientific limbo—publicly available, but lacking the imprimatur that often determines whether their findings are taken seriously.

Levi and Lu encountered that problem from both directions.

medRxiv told them their V-SAFE analysis would be better disseminated after peer review.

Yet when they submitted it to Vaccine for precisely that purpose, the journal rejected it before peer reviewers ever saw it.

Double standards

The contrast becomes more striking when considered alongside another study that Vaccine recently did choose to publish.

Just last month, the journal published online an observational study comparing cardiac outcomes following Pfizer vaccination with those following SARS-CoV-2 infection in more than four million people aged 16 to 25.

Its conclusions were highly reassuring.

The authors reported that the risks of myocarditis, pericarditis, and death were lower after vaccination than after infection — findings that strongly favoured vaccination in young people.

But Levi considered the methodology deeply problematic and posted a scathing critique on X.

“It is so outrageously flawed raising the question whether Vaccine is a scientific journal or purely propaganda operations,” he wrote.

His criticism centred on how the comparison groups were constructed.

The study covered nearly five years of the pandemic (December 2020 to September 2025), but classified more than 93% of participants as “uninfected” and fewer than 7% as vaccinated—proportions Levi labelled “impossible.”

He argued that the study excluded vaccinated individuals who later caught the virus, while only counting infected people who sought medical care.

In his view, these exclusions skewed the comparison to make vaccination appear artificially safer than infection.

“I hope Vaccine will retract this paper soon to save something from its reputation,” he added.

For Levi, the contrast is difficult to reconcile.

A reassuring observational study that he argues contains serious methodological flaws cleared peer review and was published by Vaccine.

And yet his analysis of CDC safety-surveillance data, which identified a potential vaccine safety signal, was turned away without peer review.

A broader problem

The episode has also drawn the attention of US Senator Ron Johnson, chairman of the Senate Permanent Subcommittee on Investigations, who has spent years investigating the federal government’s handling of Covid vaccine safety signals.

Johnson says Levi’s publishing difficulties reflect a broader failure by authorities to investigate and address the concerns of people reporting vaccine injuries.

“The deliberate hiding of dozens of mRNA injection safety signals early in 2021 is the biggest government scandal in my lifetime, so it doesn’t surprise me at all that Dr. Levi had trouble publishing his analysis of V-Safe.”

After several years of oversight into what he described as the failed Covid response, Johnson said he had reached a troubling conclusion.

“I have concluded that science, medicine, federal health agencies, and government as a whole (worldwide) are thoroughly and potentially irredeemably corrupt.”

His criticism targets the FDA and CDC, the federal agencies charged with monitoring vaccine safety.

“I think these agencies are hopelessly captured,” he said, adding that “every time one of their tools showed a safety signal, they denigrated the tool and stopped using it.”

Johnson said he would be happy to enter Levi and Lu’s study into the Congressional Record, and insisted the CDC must follow up with V-SAFE participants reporting prolonged post-vaccination health issues.

“Absolutely. Without question,” Johnson said.

Levi, meanwhile, intends to continue submitting the study for formal peer review.

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Dear Readers,

It has been four years since I started this Substack.

When I was kicked out of mainstream media, I wasn’t entirely sure what would come next. But being on the “outside” made me realise that I was intensely curious about a lot of things — and that made me a pretty good investigative journalist.

I enjoy finding stories, digging through documents, following leads, talking to people and discovering that something isn’t quite what it first appeared to be.

That’s really why I started this Substack.

Four years later, I’m still doing it. Interestingly, some of my leads now come from you — my subscribers.

People in this community send me studies, documents, court filings, emails and tips about things they think I should investigate. Sometimes there’s no story. Sometimes an email sends me down a rabbit hole. And sometimes it turns into something significant.

While I can’t respond to them all, I do try to read them all. So please keep them coming. I will always treat genuine sources and sensitive material with care and confidentiality.

It’s been quite a year

Looking back, I’ve covered a lot of ground over the past 12 months.

I’ve reported extensively on problems surrounding Covid vaccines — from limitations in the way they were tested and monitored, to studies making claims of benefits that don’t always stand up to closer scrutiny.

I’ve spent a lot of time following the upheaval at the CDC’s vaccine advisory committee, ACIP — reporting on its meetings, interviewing members and digging into what has been happening behind the scenes as the committee has faced unprecedented challenges.

I’ve continued investigating vaccine injuries and what health authorities knew about them, including previously undisclosed government documents and correspondence that raised uncomfortable questions about how seriously these patients were taken.

Then there were the Fauci diaries and emails — thousands of pages of records that offered a fascinating glimpse behind the curtain of the US government’s Covid response, and the web of relationships and planning that preceded it.

I’ve also returned to subjects I first investigated years ago — antidepressants, statins and the broader over-medicalisation of our health — challenging some long-held assumptions about their benefits and harms.

Help behind the scenes

I also want to thank the Brownstone Institute, which has supported my work for several years now.

Until recently, I was doing virtually everything myself. But in the coming year, Brownstone will generously provide additional support, allowing me to get some help with the research that goes into these stories.

Good investigative journalism can involve days — sometimes weeks — of reading studies, chasing documents, checking facts and following leads before there’s even a story to write.

Having someone take on some of that research means I can follow more leads and dig more deeply into the ones that matter.

I hope you’ll see the results over the coming year: more deeply researched investigations, more exclusives and, hopefully, some really exciting stories.

If you’d like to support my work

The best way to support my work is to take out a paid subscription.

An annual subscription is US$75 — which works out to just over US$6 a month. It’s also much better value than paying month-to-month.

If you’re already a paid subscriber, thank you. You can also gift a subscription to a friend, family member or colleague you think might enjoy my work.

And if a paid subscription isn’t for you, that’s completely fine. You can still help enormously by sharing my articles on social media, forwarding them to friends or simply spreading the word.

Every new reader helps this publication grow — and allows these stories to travel much further than I could ever manage on my own.

Four years ago, I had no idea where any of this would lead. I’m very glad I took the chance.

Here’s to year five — and to finding out what stories are waiting to be uncovered.

Thank you,

Maryanne Demasi, PhD

P.S. I appreciate your messages of support

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With autumn approaching in the Northern Hemisphere, the US is preparing to roll out updated flu and Covid vaccines for the coming respiratory-virus season.

But the federal advisory committee that would normally review the evidence and recommend how those vaccines should be used cannot meet.

Since March, the CDC’s Advisory Committee on Immunization Practices (ACIP) — the independent panel that develops national vaccine recommendations — has been unable to deliberate or vote.

The paralysis began when US District Judge Brian Murphy halted the appointments of 13 committee members following a lawsuit brought by the American Academy of Pediatrics and other medical groups against Health Secretary Robert F. Kennedy Jr.

Murphy concluded that suspending Kennedy’s reconstituted committee would cause minimal harm because the government could continue relying on existing vaccine schedules “for a short period.”

That was more than five months ago.

Read more

For more than two decades, Tamiflu has been a cornerstone of global pandemic planning.

Governments spent billions stockpiling it, the WHO placed it on its Essential Medicines List, and doctors routinely prescribed it to severely ill flu patients on the assumption that it could prevent complications and save lives.

But until now, no randomised trial had compared Tamiflu with no antiviral in critically ill patients.

The international REMAP-CAP trial has now put that assumption to the test—and found no benefit.

Among 442 critically ill patients with laboratory-confirmed influenza assigned to receive Tamiflu for five days, ten days, or no antiviral, the results were clear.

About 20% of patients given Tamiflu had died by 90 days, compared with about 14% of those who received no antiviral.

In other words, more patients died when they were given the drug.

The authors concluded that Tamiflu was “ineffective and highly likely to increase 90-day mortality” and should no longer routinely be administered to critically ill patients with seasonal influenza.

The new findings are the latest chapter in Tamiflu’s troubled history.

Read more

A new preprint analysis from MIT researchers examines data from the CDC’s V-SAFE system—the smartphone app used to actively monitor health outcomes following Covid-19 vaccination.

Led by Retsef Levi and Nelson Lu, the analysis of responses from nearly 10 million people aged 16 and older found that 185,285 individuals (1.87%) reported health deterioration lasting three months or longer and attributed that decline to Covid vaccination.

Roughly half of this group—about 1% of all V-SAFE participants—described their outcomes as severe, including inability to work or perform daily activities, hospitalisation, or potentially disabling symptoms.

The V-SAFE survey reports, collected between December 2020 and mid-2023, remained largely inaccessible to independent researchers until FOIA litigation by Informed Consent Action Network forced their release.

Read more

The old pharmaceutical bribe was easy to recognise. Drug company reps flew doctors to luxury resorts, paid for lavish dinners, disguised kickbacks as consulting fees, and funded educational events that were little more than sales pitches.

A recent academic review published in the Journal of Law, Medicine & Ethics examined over two decades of bribery cases, uncovering repeated patterns of sham consulting contracts, fake educational events, luxury travel, and hidden payments.

The U.S. Department of Justice has repeatedly prosecuted industry giants—Pfizer, Merck, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, and Purdue Pharma—resulting collectively in tens of billions of dollars in settlements and penalties.

Yet despite decades of high-profile prosecutions, Big Pharma’s influence over medicine has not disappeared — it has simply evolved.

Read more

When Moderna and Merck announced yesterday that their experimental mRNA cancer treatment had succeeded in a major Phase III melanoma trial, the response was immediate.

The companies called it a “landmark moment”—the first successful late-stage trial of an mRNA-based cancer treatment. News reports heralded a breakthrough. Elon Musk even declared that “synthetic RNA will cure many diseases.”

Investors were equally enthusiastic. Moderna and Merck’s market values surged, adding approximately $86 billion between them in a single trading session.

But amid the celebration, something important was missing.

The data!

No Phase III results have been published in the peer-reviewed literature, and none have been posted to ClinicalTrials.gov.

Instead, all the excitement rests on a company press release.

Moderna and Merck said the trial showed “statistically significant and clinically meaningful” improvements in preventing melanoma from recurring and spreading to distant organs.

But they have not disclosed how many patients experienced a recurrence, how large the absolute benefit was, whether it differed by disease stage, or how many patients stopped treatment because of adverse events.

The result may turn out to be impressive. But right now, we are being asked to celebrate a “breakthrough” that nobody outside the companies can properly scrutinise.

Not the “vaccine” most people imagine

Despite being widely described as a “cancer mRNA vaccine,” Moderna’s intismeran is an experimental treatment for people who have already had high-risk melanoma surgically removed.

Although they may have no detectable cancer remaining, microscopic cancer cells can survive and later cause the disease to return.

Intismeran is custom-made for each patient.

Read more

Newly recovered communications from Anthony Fauci’s government phone have exposed what senior U.S. health officials knew about Covid-19 vaccine injuries in the earliest months of the rollout.

They also reveal how calculated they were in concealing the systemic flaws in their own safety monitoring.

The documents, part of a cache released by Senators Ron Johnson and Rand Paul following an investigation into Fauci’s pandemic-era communications, directly contradict years of official assurances.

Following the release, Senator Johnson did not mince words.

“They kept saying no red flags, no safety signals,” he told Fox News. “They lied through their teeth to the American public.”

The surveillance myth

In March 2021, FDA vaccine chief Dr Peter Marks told Congress that the agency had implemented a surveillance system using “state-of-the-art technologies,” capable of detecting safety findings “in a relatively rapid manner.”

The CDC echoed that confidence, assuring the public that Covid-19 vaccine monitoring was the “most intense and comprehensive” safety program the country had ever built.

But behind closed doors, leadership knew those very systems had major blind spots.

On May 27, 2021, Dr. Janet Woodcock—then Acting Commissioner of the FDA—sent a confidential email sounding the alarm to Fauci and NIH Director Francis Collins.

Woodcock was being contacted directly by people suffering unexplained health problems after receiving one of the three authorised vaccines. Many were healthcare workers. Some she knew personally.

Their symptoms were complex, debilitating, and often difficult to evaluate with standard laboratory testing. Crucially, Woodcock warned that the very surveillance systems officials were relying on to reassure the public might fail to detect what was happening.

“These problems are not the sort that a system like VAERS would be able to detect, or even a more sophisticated population-based active follow-up such as CDC has, or a medical record-based system such as BEST,” she wrote.

In other words, Woodcock was warning that the federal safety net had a gaping hole. She doubted vaccine manufacturers would investigate “for obvious reasons” and urged Fauci and Collins to launch a dedicated cohort study.

People were suffering, she wrote, and their primary complaint was that “no one takes them seriously, no one knows how to treat them, and there is no effort to study this.”

“If you let a problem fester, then it will come back to bite you later and you are not prepared,” warned Woodcock.

Fauci’s response made clear the warning had registered.

“Janet asks what we think of this?” he wrote to Collins the next day. “We cannot ignore her. We should probably bring in CDC and see what Rochelle [Walensky] thinks.”

But publicly, officials continued to reassure Americans about the strength of vaccine safety surveillance. Privately, patients were still struggling to have their injuries recognised.

Read more

Newly released text messages recovered from Anthony Fauci’s government phone expose a glaring contradiction at the heart of the Covid-19 vaccine rollout for pregnant women.

In January 2021—mere weeks after emergency authorisations began—Fauci privately raised a concern with then-CDC director Rochelle Walensky and incoming US Surgeon General Vivek Murthy:

“Since many people have significant cytokine storm and fever after the 2nd dose, this theoretically could be associated with miscarriage in the 1st trimester,” he wrote.

Walensky agreed, noting it was “definitely a good point, [especially] after dose two.”

That concern quickly escalated beyond just a theory.

Within weeks, mRNA pioneer Drew Weissman alerted Fauci to data showing that mRNA-LNPs administered to pregnant mice crossed the placenta, reached the foetus, and generated protein that triggered an immune response in the amniotic fluid.

Weissman’s data established a plausible biological mechanism for miscarriage, showing that vaccine components could breach the placental barrier during a critical stage of foetal development.

Subsequent research reinforced those concerns. Studies have since shown that Moderna’s mRNA vaccine crossed the placenta of pregnant mice within an hour, entered the foetal circulation and accumulated in foetal tissue.

But none of this uncertainty ever made it into public messaging.

Read more

With the midterm elections approaching, reports have repeatedly suggested President Donald Trump was being urged to retreat from vaccine reform.

Robert F. Kennedy Jr.’s agenda was said to be politically toxic, with Republican strategists reportedly wanting the administration focused instead on food, chronic disease and the economy.

Much of that narrative rested on polling by Trump’s longtime pollster Tony Fabrizio, widely interpreted as showing Kennedy’s vaccine agenda was a political loser.

But the polling was never the whole story.

As I previously reported, journalist Emily Kopp revealed that another Fabrizio survey—commissioned by MAHA Action last October—found 73% of voters concerned about vaccine mandates and 90% about pharmaceutical industry influence.

A separate Zogby Strategies survey, released by the Brownstone Institute and Health Freedom Defense Fund, produced a similar picture, finding strong support for informed consent and opposition to medical mandates.

So has Trump changed political strategy? Were his advisers misreading the electorate? Or has he simply decided vaccines are an issue on which he is prepared to absorb the political cost?

Read more

When the FDA licensed Moderna’s new mRNA flu vaccine last week, legacy media coverage focused almost exclusively on efficacy.

The pivotal trial reported that the vaccine was “26.6% more effective” than a conventional flu vaccine at preventing protocol-defined influenza-like illness.

What received far less scrutiny was a much more serious problem in the trial data published in The New England Journal of Medicine—much of it relegated to an appendix behind a paywall.

An analysis of that appendix alongside the FDA’s own briefing document exposes clear regulatory malfeasance.

A statistically significant safety signal from the pivotal trial was systematically diluted until it disappeared from the official story.

The safety signal

Moderna’s pivotal Phase 3 trial (P304) enrolled roughly 40,000 adults aged 50 and older, randomised 1:1 to either the company’s mRNA-1010 vaccine or a traditional trivalent flu vaccine.

This study evaluated an “optimised” version of Moderna’s vaccine after earlier versions produced disappointing efficacy results.

Even with this updated formulation, the headline “26.6% relative efficacy” figure was misleading. In absolute terms, the vaccine reduced the risk of illness by just 0.8%.

Most concerning, however, were the serious adverse event (SAE) data.

The six-month data show that 449 participants in the mRNA group experienced at least one SAE, compared with 389 in the conventional group—an excess of 60 people.

So, while the pivotal trial showed there were 4 fewer influenza hospitalisations in the mRNA group, 60 additional people experienced an SAE.

SAEs are not mild events—they are usually severe enough to require hospitalisation, threaten life, cause significant disability, or result in death.

The imbalance of SAEs in Moderna’s pivotal trial was statistically significant—meaning it was unlikely to be a random fluke.

Yet in the briefing documents presented to the FDA’s advisory committee, VRBPAC, the agency characterised SAEs as “balanced.”

So how did the FDA make the SAE imbalance disappear?

Making serious adverse events disappear

The short answer is that the FDA used pooled data that obscured the safety signal.

Specifically, the agency relied on Moderna’s own “Integrated Safety Summary,” which combined data from four separate Phase III trials (P301, P302, P303 and P304), involving nearly 72,000 participants.

Once the pivotal trial P304 was combined with the other trials, the SAE rate became 3.1% in the mRNA group versus 2.9% in the comparator group—allowing the FDA to state that the rates were “balanced.”

Pooling data across clinical trials is common when regulators are looking for rare events. But the four trials Moderna pooled were very different in many aspects.

They tested different mRNA vaccine formulations against different flu vaccines—standard-dose and high-dose, quadrivalent and trivalent—across different age groups and countries, with follow-up ranging from six months to a year.

When these disparate trials were combined into a single analysis, the safety signal that stood out in the large pivotal trial was diluted.

The FDA accepted the approach—despite being aware of the problem.

In an appendix to its own briefing document, the FDA acknowledged that differences between the trials could produce safety variations “not fully captured by pooled analyses”—but proceeded anyway.

Table 6 of the FDA’s own review makes the switch even clearer (see below).

For the first 28 days after vaccination, when serious adverse events were still balanced between the groups, the agency reported safety results from the pivotal P304 trial alone (purple box).

But as more SAEs accumulated over the following months, a statistically significant imbalance emerged.

Instead of reporting those longer-term results from P304 in the same way, the FDA switched to Moderna’s pooled analysis (red box), where the signal was diluted enough for the agency to continue describing the rates as “balanced.”

The pooled analysis also obscured a concerning pattern in all-cause mortality.

In the pivotal trial P304, there were 40 deaths in the mRNA arm versus 34 in the comparator arm.

In the preceding trial P303, deaths were consistently higher across all three mRNA sub-studies:

• Sub-study 1 (mRNA vs Standard Trivalent): 5 deaths in the mRNA-1010 arm vs. 1 death in the comparator arm (5 vs 1).

• Sub-study 2 (mRNA vs High-Dose Trivalent): 3 deaths in the mRNA-1010 arm vs. 2 deaths in the comparator arm (3 vs 2).

• Sub-study 3 (mRNA vs Standard Quadrivalent): 3 deaths in the mRNA-1010 arm vs. 1 death in the comparator arm (3 vs 1).

Notably, in Sub-study 1, Moderna’s own trial investigators assessed one of the five deaths in the mRNA group as caused by the vaccine—the same product that has now been licensed.

Together, these numbers raise serious concerns about a possible excess in mortality in the mRNA groups—a pattern the FDA failed to highlight.

One rule for efficacy, another for safety

The FDA’s handling of efficacy reveals an even more striking double standard.

For efficacy, the agency relied strictly on study P304—the large pivotal trial testing the exact formulation submitted for licensure.

Earlier trials of Moderna’s vaccine had produced weaker efficacy results—and in at least one case, negative efficacy. Had the FDA pooled those trials for efficacy, the “26.6% efficacy” figure would almost certainly have been substantially lower.

But, as noted above, when the pivotal trial produced an unfavourable safety result, the FDA did the opposite—it pooled the data.

One approach maximised the efficacy. The other diluted the safety concerns.

Who is protecting the public?

On the surface, the FDA says Moderna’s flu mRNA vaccine is “safe and effective.”

Dig deeper, and the pivotal trial shows a statistically significant excess of participants experiencing SAEs.

Dig deeper still, and you discover the statistical trickery Moderna used—and the FDA accepted—to make the SAE signal disappear.

This brings us back to a fundamental question I have raised over years of reporting on regulatory failure.

When the FDA accepts the manufacturer’s trial design, adopts its data analyses, and rubber-stamps statistical methods that dilute a safety signal, who is actually protecting the public from harm?

Further reading:

June 2026: FDA poised to approve Moderna’s mRNA flu vaccine despite earlier rejection

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For several years, concerns over excessive DNA contamination in Covid-19 mRNA vaccines have been investigated almost entirely by independent scientists.

Researchers such as Kevin McKernan and David Speicher have continued to publish findings suggesting that levels of residual plasmid DNA in the vaccines exceed the regulatory limit of 10 nanograms per dose.

Regulators, meanwhile, have consistently maintained that their own testing shows residual DNA levels remain comfortably within acceptable limits.

Then, briefly last year, it appeared that these questions might finally receive official scrutiny.

The newly reconstituted Advisory Committee on Immunisation Practices (ACIP) signalled plans to examine previously overlooked manufacturing and quality issues, including DNA contamination.

Around the same time, FDA scientist Dr Tracy Høeg, then at the Centre for Biologics Evaluation and Research, publicly acknowledged that key scientific questions remained unanswered.

But that window of official inquiry closed quickly.

Following a federal court ruling, ACIP’s progress stalled, Hoeg is no longer at the FDA, and fundamental questions about residual DNA remain unresolved.

Once again, much of the work has fallen to independent scientists.

Now, genomics expert Kevin McKernan’s latest work brings us a step closer to a possible explanation for why measurements of residual DNA have differed so dramatically.

At first glance, his recent article is daunting. It runs for pages and is filled with technical language about PCR chemistry, molecular biology and laboratory engineering.

But for all its technical complexity, the central premise is fairly straightforward.

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Anthony Fauci has been held in contempt after refusing to answer 111 questions at last week’s Senate hearing.

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All eight Republicans voted in favour, while five Democrats opposed it and two more voted against it by proxy.

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Every attempt failed.

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The FDA had authorised the first Covid vaccines, television networks broadcast healthcare workers rolling up their sleeves, and public health officials urged millions to get vaccinated with assurances that the shots offered the path back to normal life.

But inside Dr Anthony Fauci’s private diary, a starkly different reality was already taking shape.

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The public never heard that conversation.

On 9 January 2021, less than a month after the first Covid-19 vaccine received emergency authorisation in the U.S., Fauci documented a conversation with Columbia University virologist Dr David Ho.

Ho had begun testing vaccine-induced antibodies against the newly emerging variants from the United Kingdom and South Africa, and the early results revealed some “disturbing data.”

Fauci summarised the discussion. “It looks like the vaccine might be compromised. We need to prepare to modify the vaccine if this observation holds up.”

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The private warnings escalated again on 14 January when Ho sent Fauci a note warning that “Mutants are becoming very troublesome.”

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In the weeks that followed, rather than levelling with the public about these scientific uncertainties, official messaging did the exact opposite by becoming increasingly confident.

Media commentators eagerly promoted the narrative, with MSNBC host Rachel Maddow assuring viewers that “the virus stops with every vaccinated person.”

Fauci reinforced that same illusion on 16 May 2021 when he appeared on CBS’s Face the Nation, he declared that when someone gets vaccinated, “you become a dead end to the virus… the virus is not going to go anywhere.”

Those assurances carried devastating real-world consequences. They built false expectations, drove individual medical choices, and later became the moral rationale for aggressive mandates that forced millions to choose between an injection and their livelihood.

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The conversation quickly settled into familiar territory.

Bash accused Kennedy of spreading vaccine misinformation, defended established public health positions and appealed repeatedly to scientific consensus.

Kennedy pushed back. If Bash wanted to invoke “the science,” he expected her to debate it. Whenever she offered a broad assertion, he returned to the same demand. “Cite me the study.”

The exchange exposed a fundamental weakness in modern health reporting.

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