A new Australian study has uncovered a striking difference between the lipid ingredients in Pfizer’s and Moderna’s Covid vaccines.

While both use tiny fat particles known as lipid nanoparticles to protect and deliver mRNA into cells, researchers found that Pfizer’s primary lipid lingers in the bloodstream considerably longer than Moderna’s counterpart.

For years, attention has focused overwhelmingly on the mRNA and the spike protein it produces. The lipid nanoparticles have attracted far less scrutiny, largely regarded as little more than delivery vehicles.

But what if the delivery system itself is a major part of the problem?

Because lipid nanoparticles can provoke inflammatory reactions even without mRNA inside them, these findings raise fresh questions about whether prolonged exposure to these ingredients could contribute to vaccine injuries.

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Two months ago, Moderna and Merck announced that the personalised mRNA cancer vaccine Intismeran had succeeded in a major Phase III melanoma trial when combined with the immunotherapy drug Keytruda.

The companies called it a “landmark moment.” News reports declared a breakthrough, and investors piled in. But as I reported at the time, the companies had not released any meaningful Phase III data.

They said the trial had met its endpoints, but provided little detail. There was no way for anyone outside the companies to judge how much benefit Intismeran added to Keytruda—or what harms patients experienced.

We were told the data would be presented at the European Society for Medical Oncology congress in Madrid this Saturday.

But now, the data have been leaked.

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A new study published in the Annals of Internal Medicine has generated alarming headlines about the possible consequences of proposed changes to America's longstanding recommendation to vaccinate every baby against hepatitis B at birth.

Researchers from Harvard Medical School and Massachusetts General Hospital predict that allowing parents and doctors greater discretion over vaccination could increase chronic childhood hepatitis B infections by a staggering 83%.

The New York Times wasted little time amplifying the findings under the headline, “Kennedy’s Vaccine Plan Could Cause Surge in Hepatitis B, Study Finds.”

It’s a frightening statistic, but where did it come from?

The researchers did not track infections after the policy change or follow families who chose to delay vaccination. They simply ran a computer simulation built on assumptions that have never been clearly validated.

We’ve seen this before.

During Covid, mathematical models forecasting catastrophic death tolls dominated headlines and helped justify unprecedented restrictions on everyday life. Only later did serious flaws emerge in some of the assumptions underpinning those predictions.

Have we learnt nothing from those mistakes?

The 50% assumption

To arrive at their prediction, the Harvard researchers modelled what might happen to 3.6 million American children over 20 years.

After ACIP recommended shared decision-making, the researchers assumed hepatitis B vaccination completion would plunge to just 50%.

So where did that figure come from?

They borrowed uptake figures from other immunisation programmes — including a new, costly RSV monoclonal antibody that isn’t even a vaccine. Hardly a sensible comparison with a long-established hepatitis B vaccination programme.

But that unverified assumption helped produce the headline-grabbing 83% increase.

Sounds dramatic, doesn’t it? But that’s because it’s a “relative” increase.

In “absolute” terms, the model predicts just 212 additional chronic infections among 3.6 million children over 20 years — an increase in risk of approximately 0.006%.

That paints a rather different picture from the “surge” suggested by the New York Times headline.

Transmission rates built on guesswork

The researchers had to estimate how often American children might catch hepatitis B to build their mathematical model.

But in the supplementary documents, they admitted that “there is no reliable estimate” of childhood hepatitis B transmission risk in the United States.

So what did they do?

The researchers simply guessed how often American children might encounter hepatitis B, then used research from sub-Saharan Africa to estimate their chances of becoming infected. They assumed the risk of infection following exposure would be the same in both populations.

At ACIP’s December 2025 meeting, research was presented suggesting that hepatitis B transmission between people during childhood — known as horizontal transmission — was rare among most American children.

And here’s why that is so important.

Of the 212 additional chronic infections predicted by the model, 204 (or 96% of the increase) depend on precisely this kind of transmission.

In other words, almost the entire predicted surge rests on infection risks the researchers admit they cannot reliably estimate for American children.

How much confidence can anyone place in a prediction built on such uncertain assumptions?

More assumptions, more infections

The questionable assumptions didn’t end there.

The researchers modelled a scenario in which only 50.1% of babies whose mothers’ hepatitis B status was unknown received the vaccine at birth, even though ACIP had explicitly retained the birth-dose recommendation for these babies.

Where did that figure come from? An old CDC report showing that roughly half of all American newborns received hepatitis B vaccination within three days of birth in 2003–2005 — not specifically babies whose mothers’ infection status was unknown.

The researchers applied this decades-old statistic to a group still recommended for vaccination at birth, without evidence that it reflected their actual uptake.

That single assumption generated another 197 predicted chronic infections under each alternative vaccination policy.

Those infections were not part of the headline 83% increase, but they illustrate how dramatically the projections can shift when researchers change just one assumption.

What about potential harms?

There’s another fundamental question the Harvard model leaves unanswered.

The researchers estimated the benefits of universal birth-dose vaccination but did not weigh them against potential vaccine harms, instead citing existing evidence supporting vaccine safety.

The original hepatitis B vaccine safety trials were far too small to reliably detect very rare adverse events, and post-marketing surveillance has limitations of its own.

If researchers are prepared to model an absolute increase in infection risk of just 0.006% over 20 years, shouldn’t a proper risk–benefit assessment also examine potential vaccine harms occurring at similarly low frequencies?

Instead, the researchers brushed past potential harms and recommended reinstating universal birth-dose vaccination.

Where was the scrutiny?

The New York Times did little to question the study’s assumptions before amplifying its alarming findings.

It quoted the lead author, supporters of universal vaccination and a former ACIP chairman who criticised the policy change.

But not a single member of the ACIP committee that actually voted for the change was quoted. Their perspective might have exposed some of the study’s weaknesses before the story went to print.

The New York Times also overlooked an obvious real-world comparison.

Britain begins routine hepatitis B vaccination at eight weeks, while Denmark reserves it for higher-risk groups, and both have maintained low levels of childhood hepatitis B infection.

Also, in Canada, Ontario routinely vaccinates children against hepatitis B at around age 12 rather than at birth, with no documented surge in childhood infections.

These are precisely the kinds of questions and comparisons that should be examined before alarming projections are presented to the public.

Mathematical models can be useful, but their predictions are only as credible as the assumptions behind them.

When those assumptions cannot be reliably checked against real-world scenarios, presenting the results as a looming public health disaster is grossly misleading.

The Harvard study does not demonstrate that shared decision-making will cause an 83% surge in childhood hepatitis B infections. It shows how easily questionable assumptions can produce frightening predictions — and how quickly those predictions become political headlines.

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Jeremy Faust, editor-in-chief of MedPage Today, has described how the former Advisory Committee on Immunisation Practices (ACIP) operated before Robert F. Kennedy Jr replaced its members in June 2025.

During a recent interview with Jeanne Marrazzo, chief executive of the Infectious Diseases Society of America (IDSA), Faust said recommendations from the traditional ACIP followed “a long process behind closed doors.”

By the time the committee met publicly, he said, votes were “almost always unanimous” because “the decisions were really made in meetings.”

Faust’s remarks were notable because they appeared to substantiate the very criticism Kennedy had made of the old ACIP.

Kennedy had described the committee as a “rubber stamp” for decisions already settled behind closed doors, citing concerns about conflicts of interest and public trust.

Robert Malone, a former vice-chair of Kennedy’s reconstituted ACIP, interpreted Faust’s remarks as confirmation of longstanding concerns.

“I am glad to see that this is finally being acknowledged,” he told The Defender. “I have known that this was the case for literally decades.”

Retsef Levi, an MIT professor who chaired the reconstituted ACIP’s Covid vaccine workgroup, took a similar view, calling Faust’s remarks a “striking disclosure.”

Speaking with MD Reports, Levi said that if voting decisions had been settled privately before public meetings, this would, in his view, have breached the Federal Advisory Committee Act (FACA).

“When we were trained as new ACIP members on what the FACA rules stipulated,” Levi explained, “the one thing that was emphasised again and again was that we could not privately discuss our future votes as a group or in subgroups, other than during public meetings.”

Dr Kirk Milhoan, who chaired Kennedy’s reconstituted ACIP, described his committee’s approach.

“Yes, I agree with Retsef,” Milhoan told MD Reports. “We never knew how the votes would turn out before the public vote.”

He added, “We were constantly asking for clarification of the FACA requirements so we would not be in violation.”

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MD Reports has obtained and analysed a trove of Argentinian regulatory and trial documents, together with internal correspondence from the European Medicines Agency, revealing serious failures in the conduct and oversight of Pfizer’s pivotal phase III Covid-19 vaccine trial.

Previously undisclosed records expose medication errors, deficiencies in participant safety monitoring, conflicting assessments of serious adverse events and an independent ethics committee formally sanctioned over failures to protect research participants.

At the centre of the investigation is Site 1231, a hospital in Buenos Aires that recruited nearly 5,800 volunteers — approximately 13% of the entire trial — making it one of Pfizer’s largest research centres.

Argentina’s drug regulator documented 20 findings of non-compliance, but Europe’s medicines regulator later cited those same inspection records as evidence that the site had complied with international standards.

The documents reveal what Pfizer and international regulators knew, how they responded and how the European Medicines Agency ultimately closed its investigation without obtaining the further answers it had sought from Argentina.

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By the time people reach their 70s, many are already taking several medications daily.

Adding another drug for the rest of their lives should therefore come with a meaningful benefit, especially when the person is otherwise healthy and has never had a heart attack or stroke.

That question lies at the heart of one of the largest statin trials ever conducted in older people.

The Australian-led STAREE trial enrolled almost 10,000 relatively healthy adults aged 70 and older who had no history of cardiovascular disease, dementia or diabetes, and randomly assigned them to 40mg of atorvastatin or placebo.

The trial was designed to ask not only whether statins could prevent cardiovascular events, but whether they could help older people “prolong good health and maintain independence.”

The results were recently published in the New England Journal of Medicine.

As is common with statin trials, the headline sounded impressive.

Atorvastatin, the most commonly prescribed drug in America, reduced major cardiovascular events by 30%.

One might reasonably assume that meant these healthy older people were substantially better off taking a statin.

But an examination of the trial documents, including the protocols, peer-reviewed paper, supplementary data and trial registry, reveals a far more sobering trade-off.

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Robert F. Kennedy Jr has been talking about how artificial intelligence will revolutionise medicine.

Some of what he says I agree with. But after speaking with experts who have spent decades working with AI and healthcare data, I think some of Kennedy’s assertions warrant caution.

Speaking at the MAHA Summit in Washington DC last week, the US Health Secretary said AI could eventually give ordinary Americans access to a second medical opinion that was “much better informed than any doctor in the country.”

Kennedy argued that Americans would no longer have to be dominated by public officials telling them to “Trust the experts,” because they could verify medical advice for themselves.

He specifically pointed to officials asserting that masks work, that social distancing works, and that Covid vaccines prevent infection and transmission, suggesting “AI might correct that” and help free people from “medical tyranny.”

Others in the administration went even further, with HHS senior adviser Calley Means posting on X that it would be “medical negligence” for a doctor to give a patient advice without insisting they consult AI for a second opinion.

I often use Grok AI to search for studies, locate documents, and dig out references.

So, I asked it three simple questions on topics where Kennedy has taken firm, high-profile stances — do vaccines cause autism? Is fluoridation of the public water supply harmful? And does Wi-Fi cause cancer?

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It is a painful read, but an important one.

Cries for Help — Injury and Death Buried in V-Safe Data, compiled by React19 and published by the Brownstone Institute, gathers messages from people who became ill after vaccination, alongside relatives writing for loved ones who were too sick to respond or had died.

They submitted these accounts through a CDC system — the V-SAFE app — designed to monitor Covid vaccine safety during the mass roll-out.

It took litigation under Freedom of Information laws and a federal court order to compel the CDC to release the free-text responses, which the Informed Consent Action Network (ICAN) then published.

React19 reviewed more than 7.5 million responses and identified 3,329 participants who pleaded for help, described suicidal thoughts, or reported deaths and near-death experiences.

Some described frightening symptoms that would not go away. Others had been to doctors or emergency departments but still had no answers. They kept filling in the surveys, hoping someone on the other end would notice and respond.

Again and again, they asked a version of the same question.

Is anyone reading this?

One person reported a miscarriage and said they had asked to be contacted, but nobody had called. Another was promised callbacks twice, then wrote a year later that neither had happened.

Some of the hardest entries come from grieving relatives.

A son reported that his father was in intensive care and asked for help. His next update said his father remained critically ill. Then came the message that he had died.

Another respondent repeatedly reported a woman’s death while continuing to receive check-ins. “Still dead. — Funeral home. She DIED”

Weeks later, the frustration had become fury. “She died after her vaccine but none of you Assholes read this and just continue to send this useless text — FUNERAL HOME!”

Brownstone president Jeffrey Tucker has been reading the messages aloud in broadcasts on X, giving these people a voice beyond the database. Hearing their words brings home the grief, fear and anger behind each entry — and the expectation that reporting a problem would lead to help.

But that help never came.

Remember, these people got vaccinated. They took part in the safety monitoring authorities asked them to use. But when they reported harm and asked for help, they were dismissed as “antivaxxers.”

The abandonment described in these pages added insult to injury. These people deserved care and investigation, but found themselves fighting to be heard.

Their accounts also underline the urgency of Retsef Levi’s call for the CDC to follow up people reporting lasting health problems after vaccination.

His team’s analysis of V-safe data found that nearly 2% of almost 10 million participants reported health deterioration lasting at least three months, which they attributed to Covid vaccination.

This week brought some hope of action.

According to Bloomberg, health secretary Robert F Kennedy Jr attended a ribbon-cutting ceremony on 5 October for a new NIH clinic intended to study and care for patients with vaccine injuries.

We still need to know who will qualify and how patients can access care. For families who have spent years searching for help, the announcement must lead to more than another promise.

One message in the book captures what so many were asking.

“You stole my life - call me, hear me, help me.”

It should never have been too much to ask.

Download:

Cries For Help Book

3.54MB ∙ PDF file

Download

Download

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It became one of the most familiar stories of the pandemic.

“I got jabbed and the next week I caught Covid.”

At the time, it was brushed off as a coincidence, or simply a case of the vaccine “not having kicked in yet.”

But these were not just anecdotes.

MD Reports examined the studies and found that the pattern had been hiding in plain sight, without the public ever being told.

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Docket No. HHS–OS–2026–0332

Maryanne Demasi, PhD
Medical scientist and investigative journalist
Editor, MD Reports

Submitted on Sept 19, 2026

I welcome the Department’s review of federal vaccine recommendations and the role of shared clinical decision-making.

As a medical scientist and investigative journalist, I have spent years examining the evidence underpinning vaccine policy, from clinical trials and safety surveillance to regulatory standards and vaccine advisory processes.

This submission draws on that body of work.

Federal vaccine recommendations carry enormous weight. They shape medical advice, public understanding, insurance coverage and state or institutional rules.

With that influence comes an obligation to ensure that recommendations rest on rigorous evidence and communicate clearly what is known, what is uncertain and what remains unknown.

A recommendation should not simply tell people that a vaccine is “recommended” or that its “benefits outweigh the risks.” People should be able to see the evidence behind that judgment and decide what it means for them.

The sections below set out where I believe that process should change.

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Massive datasets containing the health records of millions of patients now underpin thousands of studies on drug safety, vaccines and treatment effectiveness.

Regulators are increasingly relying on them too.

Last December, then-FDA Commissioner Marty Makary announced plans to expand the agency’s use of “real-world evidence” in regulatory decisions.

“We’re removing unnecessary barriers that have prevented us from using powerful real-world evidence to get life-changing treatments to patients faster,” Makary said.

There are valid reasons for the shift. Electronic health records covering millions of patients can reveal rare side effects and long-term outcomes that clinical trials may be too small or too short to detect.

But there is a problem. Much of this research relies on enormous, heavily processed datasets that researchers and independent reviewers cannot readily check against the original hospital records.

The danger became clear during the Surgisphere scandal in 2020, when the database underpinning a major Covid-19 study that influenced health policy turned out to be fake.

Six years later, the same fundamental problem remains.

If neither researchers nor independent reviewers can trace the data back to the original medical records, how do we know they are reliable?

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In a move that will blindside supporters of Health Secretary Robert F. Kennedy Jr, the CDC has quietly reverted to its old Covid vaccine recommendations.

There was no official announcement or media fanfare. The agency simply updated its 2026–27 guidance, recommending Covid shots for healthy infants, children and adults — including outside FDA-approved indications.

It comes despite the FDA restricting vaccine approvals in people under 65 to higher-risk groups, and despite federal scientists linking child deaths to the shots.

Just last week, Kennedy sought to reassure his supporters, urging patience as he acknowledged their frustration with the slow pace of change.

“Let me be clear,” he declared. “You have a strong and steadfast friend at the White House.”

Now, for supporters who banked on Kennedy ending childhood Covid vaccination, that reassurance lies in tatters.

And it has happened under his watch.

What changed?

Citing “legal uncertainties and inquiries” surrounding its advisory committee, CDC has reverted to its July 2025 Covid vaccine recommendations.

The decision has created a divide between FDA approval and CDC guidance.

While FDA has restricted Moderna’s Spikevax and Pfizer’s Comirnaty in people under 65 to those at increased risk of severe Covid, the CDC is promoting much broader guidance:

• Adults (18+): A 2026–27 Covid vaccine is recommended for all adults, regardless of health status.

• Healthy children (6 months–17 years): Vaccination is recommended through “shared clinical decision-making” between families and healthcare providers.

• Immunocompromised children (6 months–17 years): A 2026–27 vaccine is recommended for all children who are moderately to severely immunocompromised.

In practice, the CDC is recommending off-label vaccination for healthy adults and children when that use falls outside FDA-approved indications.

This includes young males aged 12–24, the group with the highest observed risk of vaccine-associated myocarditis, even as the FDA says it lacks “substantial certainty” that the benefits outweigh the risks for healthy people.

For infants, the divide is even more glaring.

Moderna’s Spikevax — the only Covid vaccine available for children aged 6–23 months — is FDA-approved only for those with an underlying condition that puts them at high risk of severe Covid.

But the CDC advises that a healthy, previously unvaccinated baby should receive a two-dose series — and explicitly identifies that use as “off-label.”

Is this really “shared decision-making”?

The CDC says Covid vaccination of healthy children should rest on “shared clinical decision-making.”

But that only works if parents are given enough information to make an informed choice.

The agency does not quantify what benefit a healthy baby can realistically expect from vaccination or clearly explain the limits of that protection.

Other countries are more transparent. Britain, for example, states plainly that current Covid vaccines provide “limited protection against mild infection and no evident protection against transmission.”

Denmark is equally candid about the low risk faced by most children, stating that “only a small number of children need seasonal vaccination against COVID-19,” with vaccination requiring an individual medical assessment.

To ensure true informed consent, parents also need a clear account of the harms and uncertainties, including the proposed warnings from the CDC’s own ACIP workgroup about myocarditis deaths, prolonged post-vaccine illness and unresolved safety questions.

Without that clarity, how meaningful is “shared decision-making”?

The AAP gets what it wanted

The CDC’s updated guidance almost mirrors that of the American Academy of Pediatrics (AAP).

On 2 September, the AAP published its 2026–27 recommendations, calling for Covid vaccination of all infants aged 6–23 months and recommending it for older children based on their risk and parents’ preferences.

Now, three weeks later, the CDC has followed with guidance covering essentially the same childhood population.

For an administration that promised to challenge the medical establishment, it is a staggering surrender — particularly given that the AAP receives substantial funding from vaccine manufacturers.

Kennedy was warned

Recently, more than 160 physicians, scientists and activists, including myself, sent an open letter to Kennedy and President Trump raising a series of objections, including the continued vaccination of children and the FDA-identified deaths.

Many of Kennedy’s supporters endured censorship, professional repercussions and public ridicule for questioning whether healthy children should receive Covid vaccines.

They expected his appointment to bring a decisive change in policy. For many, this will feel like betrayal.

The irony

When HHS overhauled the childhood vaccination schedule in January, Kennedy justified the reforms by declaring: “We are aligning the U.S. childhood vaccine schedule with international consensus while strengthening transparency and informed consent.”

The irony now is that US Covid vaccine guidance points in the opposite direction.

Across much of Europe, Britain and Australia, Covid vaccination is largely targeted at older people and those at increased risk, with healthy children generally excluded from guidance.

Kennedy cannot win every administrative battle. But Covid vaccines were never a minor issue for him. As HHS Secretary, he wields substantial authority over federal vaccine policy, raising an obvious question — why didn’t he intervene?

In 2021, Kennedy called on the FDA to “immediately remove Covid vaccines from the market.” Months later, he described the Covid vaccine as the “deadliest vaccine ever made.”

Now, under Kennedy’s leadership, the CDC recommends Covid vaccination for healthy babies, children and adults — even beyond FDA-approved indications.

CDC website: https://www.cdc.gov/covid/hcp/vaccine-considerations/overview.html

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On 22 May 2020, The Lancet published a study that changed the course of the Covid-19 pandemic.

It purported to analyse the medical records of 96,032 patients hospitalised with Covid-19 across 671 hospitals and six continents, delivering a damning conclusion about an old antimalarial drug — hydroxychloroquine.

Patients treated with hydroxychloroquine alone or with a macrolide antibiotic appeared more likely to develop dangerous heart rhythm disturbances and more likely to die.

The study’s findings dealt a major blow to hydroxychloroquine — a cheap, off-patent drug that was already at the centre of a fierce political battle.

President Donald Trump had publicly championed hydroxychloroquine as a potential Covid treatment and called for research to be accelerated — even revealing that he was taking the drug himself.

Within days of the study appearing in The Lancet, the World Health Organisation suspended the hydroxychloroquine arm of its multinational Solidarity trial. Other trials were interrupted, and treatment policies changed around the world.

The study carried enormous authority because of its size. Nearly 100,000 patient records appeared to provide the kind of real-world evidence clinicians desperately wanted while conventional randomised trials were still underway.

But there was a problem — investigators quickly concluded the database was fake.

The company behind it was Surgisphere, an obscure Chicago operation. What followed was one of the most extraordinary scientific collapses in modern history, exposing how easily global health policy could be swayed by unverified data.

Six years later, Surgisphere is worth revisiting — not as a one-off pandemic anomaly, but because the weakness it revealed in modern healthcare data has only become more consequential.

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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.

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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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