Dirty trot in new vaccine trial offered to the elderly.
by specialist Jeanne A. Rungby, MD.
Moderna's globally highly criticized new mRNA-based influenza vaccine, mFlusiva, is hidden in a new large-scale government-funded vaccine trial for seniors aged 65 and over in Denmark and Spain
When I received the invitation via digital mail, I became curious.
I had just read about the very dangerous new mFlusiva, which may have been approved by the US Food and Drug Administration (FDA), but despite this approval, the US Centers for Disease Control and Prevention (CDC) has chosen not to recommend mRNA-1010 for the 2026 and 2027 seasons. The CDC received warnings from a number of researchers about an unusually high number of deaths and serious side effects from this vaccine.
My first thought was that the Danish Medicines Agency could not possibly allow mFlusiva to be given to Danes under any circumstances.
But I had to get smarter.
Only after correspondence with a doctor in the project group, who sent me some scientific articles about the influenza part of the vaccine (mCombriax) - and after delving into the accompanying data, did I finally get confirmation that the mRNA influenza vaccine offered to up to 410,000 Danes is actually identical to this dangerous product.
Up to a third of Danes over 65 years of age have received - or will receive - an invitation to participate in a trial of a combination vaccine (mCombriax, mRNA) against both influenza and COVID19 in one shot. 1 This study will take place in Denmark and in the province of Galicia in Spain. It will start in October 2026.
The question is, what is the real purpose of this experiment, now that we know how dangerous they are?
Today, 6 years after the population was de facto forced to take the experimental mRNA gene therapy-based COVID-19 vaccines, there are more than 4,500 scientific studies documenting that they have caused serious illness and death, including debilitating and fatal neurological disorders, autoimmune diseases, and prion diseases. 2,3
There is an extreme excess mortality throughout the mRNA-vaccinated world that is demonstrably not due to COVID-19. 4,19 Researchers estimate that from 2021 to September 2023, there was an excess mortality of more than 17 million people worldwide, which they attribute to the COVID-19 vaccines. 4 This excess mortality can be temporally related to these COVID-19 injections and meets common criteria for presumed causality in science (the Bradford Hill criteria). 4
Even pregnant women, fetuses, and children have died in close relation to these injections. 5,6
In addition, there is a serious and significant decrease in fertility, which can also be attributed to these mRNA products. 7
There has also been a sharp increase in cancer since 2021, which is clearly not due to smoking. 8, 9
So why haven't the authorities stopped this mRNA technology long ago?
Perhaps this is due to their own role in political initiatives including forced vaccinations and also strong financial interests invested in this technology combined with the fact that drug administrations in most countries have passed under the overall command of the WHO. 10
A lookup and search on the American clinicaltrails.com , which registers all clinical trials, will show that more than 400 clinical trials with mRNA technology are underway. A lot of money has thus been invested in this technology.
With the knowledge I have acquired about mRNA technology, as referred to above, and the way authorities and industry are conducting scientific experiments in recent years, my hypothesis is the following:
These mRNA injections carry an excessively high risk of morbidity and shortening the lives of people over 65 years of age.
If this is true, one can speculate about the motives. Below I will document my claims and attempt to answer my hypothesis.
The vaccines in the trial:
The vaccine being tested in this trial is a combination vaccine (mCombriax), which consists of Moderna’s Spikevax (mRNA1273) and an influenza combination mRNA vaccine that targets 4 subtypes of influenza. In total, the combination vaccine targets a total of 5 antigens (foreign proteins), one of which is the spike protein from COVID-19-omicron. 8, 9 These vaccines are also packaged in four lipids, 2 of which are foreign.
The comparison is not, as one might think, with a group that receives saline. Instead, it is compared with a group that receives the same mRNA COVID19 omicron vaccine (Spikevax) as well as a high-dose traditional combination vaccine against 4 influenza antigens given in two injections on the same day. In addition, the same 4 fats are added.
The attentive reader will think that the two groups are getting almost the same cocktail, which is really smart if the producers don't want to find any differences between the two groups.
The question that then arises is; what is the purpose of not finding any differences between the two experimental groups?
We will return to this in the discussion of the experimental design later.
Below is a screenshot of the invitation.
"Studies suggest that the combination vaccine provides a better immune response against both influenza and COVID-19 than the current vaccines, which are administered separately. However, there is limited knowledge about how the vaccine works against severe cases of influenza or COVID-19.
Therefore, the purpose of this trial is to investigate how a combination vaccine against influenza and COVID-19 works compared to the current vaccines, which are administered as separate shots.
How does it work?
Anyone 65 years of age or older who understands Danish or English can participate.
You can sign the informed consent form electronically before your visit.
The study requires your presence only for the actual vaccination visit. Aside from a questionnaire, all follow-up is conducted via patient records and the national health registries.
You can participate at Danske Lægers Vaccinations Service clinics throughout the country.
The trial is a randomized trial: You will either receive one dose of the combination vaccine—or two doses consisting of a high-dose flu vaccine and a COVID-19 vaccine, respectively. You will be informed during your visit which vaccine(s) you will receive. The vaccines are free of charge"
It is not clear from the invitation that :
· it was about mRNA vaccines. You have to go all the way down to the product summary for the various vaccines included in the trial to get this information. Many people want to avoid mRNA vaccines - but not traditional vaccines. For participants in the trial, this is therefore important information that should be on the invitation itself.
· there is a risk of myocarditis and pericarditis as well as other serious conditions , including serious neurological and autoimmune disorders and death as a result of the vaccines. Here, 6 years after conditional approval was granted, there are large amounts of scientific articles, including a number of studies, documenting the harmful effects of these products while also showing little effect.2, 3, 7, 8, 9
· there are clear indications that vaccines using mRNA technology have increased the risk of death. 4, 5, 6, 19
· only the influenza part of the vaccine (mCombriax, mRNA1083) is the same as mFlusiva (mRNA1010), 11 which was recently approved by the FDA. Despite this approval, the CDC (the US Centers for Disease Control and Prevention) has not recommended mRNA-1010 for the 2026 and 2027 seasons.12
This is likely due to:
o 155% (23) had an increased risk of unexplained death in the mFLUSIVA group (mFlusiva) compared to 9 in the control group, who received traditional inactivated influenza vaccine (not saline).
o 515% had an increased risk of disability .
o To prevent hospitalization in 5017 should be injected and
o 5.5 percent experienced grade 3 serious adverse events.
o For every hospitalization that was prevented, 2 died and 233 suffered serious side effects.
o Vaccine efficacy was 26.6%. Overall, a negative benefit/disadvantage profile. The authors conclude on this basis that Moderna should be stripped of their mFLUSIVA license.
· no real placebo studies (saline) have ever been conducted with material from the commercial manufacturing process in any of the mRNA studies, neither the influenza part nor the Moderna Spikevax part. The risk of illness and death for unvaccinated people is unknown. The manufacturing process referred to in product summaries is different from the one given to the public. The difference is ignored by authorities, but they cannot document their claims.17
· two of the 4 lipid nanoparticles are not naturally occurring in the body and that there is no study on humans that shows what happens to these lipids . Even animal studies are flawed. How can one declare that “the majority of these fats are excreted in 2 – 3 weeks” when no proper distribution studies have been conducted on humans or animals?
· measuring antibodies (“immune response”) is not the same as efficacy and safety , because antibodies can be divided into subgroups (subclasses) with different purposes. An increase in IgG4, for example, is very inappropriate and associated with cancer.
· there is a risk of contamination with DNA and endotoxins (parts of bacteria), which can cause serious side effects and death. In Moderna's own patent from 2019, they acknowledge this risk.13, 20
· None of the vaccines have been studied for their ability to trigger cancer or change genes. The project staff assures me that these are not genetic vaccines. Here the project staff are misinformed. The following is from Pfizer's article on mRNA vaccines14
"At Pfizer, we utilized prior plasmid DNA (pDNA) manufacturing technology expertise from Pfizer's Gene Therapy Program. This involved quickly screening all four plasmids for each vaccine candidate in parallel in five separate E. coli cell lines that were available."
In addition, the Danish Medicines Agency used the term genetic vaccines early in the pandemic management process.
It appears from the Danish Medicines Agency's website that the genetic code for the spike protein "is broken down and is not stored in the body after vaccination."
This statement has been shown to be subject to modifications, among other things because it was not studied before approval (Integration Studies).
Many independent laboratories have since found that these products contain precisely the genetic code as well as other impurities that far exceed the limits of what is permitted. 15 Various health authorities, including the EMA, have been asked to address this problem. 16
The design of the experiment.
My questions to the research team's doctors and their responses have revealed that:
· There is no placebo group (saline) in the study.
· No blood samples or biopsies (objective measurement data) are taken from the subjects either before or after vaccination. The only systematically collected information for their evaluation is subjective responses to a questionnaire.
· The trial participants are not blinded. This gives rise to what is called bias, namely that the trial participants' answers to questions can be influenced by their beliefs about the trial product they have received. A belief that can be influenced by the information from the project staff who give the vaccines. If one had chosen to add a group that received saline in one shot, one could have easily made the trial double-blind, which is the correct scientific approach.
· The manufacturers are given access to the patient records of the trial subjects 10 years before and 20 years after participation. However, it is not stated anywhere in the information material what information (measurement data) is extracted from the records and who checks what is extracted and why. One may fear that this is a blank check for data. Apparently, systematic data is not collected from all trial subjects, as if, for example, all participants were taken in for outpatient check-ups and various examinations such as blood tests, biopsies, ECGs or heart MRI scans were performed.
· There are no diagnostic codes for diseases that arise as a result of mRNA technology (which is governed by WHO). This means that if a subject is hospitalized with a condition caused by these vaccines, it will not necessarily be recorded as a vaccine injury. This creates a great deal of randomness and subjectivity in data collection and thus the possibility of data manipulation. There is thus a very high probability that serious side effects will go under the radar and remain unrecorded. This is seen as a significant limitation of the trial.
· Autopsies of deceased trial participants - regardless of cause - are not included in the trial design.
· Both manufacturers and health authorities are exempt from liability as any registered and reported damages must be covered by taxpayers in a system governed by a “no-fault compensation scheme” . Taxpayers pay any compensation for damages.
· It is based on the subjective assessment of the project staff whether injuries are considered to be caused by the vaccines in the trial and therefore must be reported. There is therefore no systematic reporting of injuries.
It is common regulatory practice these years that as long as no significant differences are demonstrated between the two groups where the vaccines in the comparison group are already approved by the FDA and EMA (the European Medicines Agency), then the new combination vaccine will also be approved by the drug authorities. 17 The authorities do not require any placebo-based studies on the product itself and the actual manufacturing method, only comparability studies.
This does not mean that the vaccines in the two groups cannot be dangerous.
They just have to be roughly equally dangerous to gain approval. 17
How do manufacturers ensure that the two products are equally safe/dangerous?
There are various design measures that manufacturers can take. The essential ones are to avoid placebo control (saline), ensure that the comparison groups are relatively similar, and avoid systematic collection of compromising data, which is fully met in the design of this trial.
There are other possible steps in the actual processing of data. Some data can be excluded, just as the choice of statistical calculation methods has an impact on the result.
A relatively recent study of mRNA vaccine batch-dependent differences in excess mortality showed a systematic pattern that revealed that Moderna's Spikevax ( 39,483 doses per batch in the Czech Republic) could be divided into 3 different groups. Such studies are often used to monitor products after marketing.
In a uniform product there should only be one group – not 3 groups. 18
see figure from the study: The 3 lines show that Spikevax contains 3 different vaccines.
Pathway of side effects through the system:
Many people mistakenly believe that the registration of side effects is carried out by objective authorities under democratic control. However, this is not the case.
WHO is responsible for the overall monitoring of adverse reactions via VigiBase (WHO Collaborating Centre in Uppsala). It is a private company that is not subject to the Freedom of Information Act on access to documents, despite the fact that they handle adverse reaction data from at least 160 countries. Through this monitoring system (EudraVigilance), the manufacturers (Moderna and Pfizer) are allowed to decide whether reported adverse reactions should be valid or declared “invalid”. 10
The WHO's largest contributor is Bill Gates, or the foundations he controls. This funding comes with strings attached. 10
In May 2024, the Danish Medicines Agency was administratively placed under the WHO, as a “WHO related authority”. This means that the Danish Medicines Agency, like other medicine authorities in Europe, must follow approximately 260 criteria in their daily work.
One of the criteria is the definition of an SAE (a serious adverse event). It can by definition not last more than days! This definition means that patients who complain of disability as a result of the vaccines have their complaint rejected because the symptoms last more than 4 weeks. 21
If the Danish Medicines Agency hires subcontractors for tasks, these subcontractors and details of the agreement must be approved by WHO Headquarters.
It is also stated in the employees' contract with the WHO that they must have " the best interests of the WHO at heart, as opposed to representing the views of their employers, other institutions or governments."
Both the EMA and the European Commission became “WHO related authorities” in 2015 - before the rollout of these genetic vaccines. They must follow the same rules. 10
The review above – as well as common sense – shows that these mRNA products from Moderna have not been sufficiently safety tested and it appears that the entire system for testing and approving vaccines rests on a very thin and corrupt foundation, both in terms of early approvals and going forward.
Personally, I find this experiment both unscientific and unethical , as there is sufficient documentation in the literature to put an end to these products.
The results are almost a given in advance.
On this basis, I hereby issue a warning to all citizens over the age of 65, in both Denmark and Spain (Galicia).
In my opinion, the risks of participating in this trial far outweigh the benefits.
I therefore advise against participation.
References:
9. Review article: Kuperwasswer C et al: COVID vaccination and post-infection cancer signals: Evaluating patterns and potential biological mechanisms. https://www.oncotarget.com/article/28824/text/
11. Spergel AKR et al. Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. YAMA. 2025. https://jamanetwork.com/journals/jama/fullarticle/2833668 (PMID: 40332892)
12. Hulscher N et al. Reanalysis Of FDA Clinical Data For MFLUSIVA (MRNA-1010) https://journalofindependentmedicine.org/articles/v02n05a07/
17. The Danish Medicines Agency's response to access to documents of 12 August 2024 ( https://www.wch-scandinavia.org/post/lægemiddelstyrelsens-svar-på-forespørgsel-ved-proces-2-comirnaty ).
18. Schmeling et al: A batch-Dependent Safety Signal Related to All-Cause Mortality Associated with COVID19 Vaccination https://www.preprints.org/manuscript/202603.0908
19. Rancourt D: Eight pivotal facts about Covid-period excess mortality, https://zenodo.org/records/20162806
Below is a transcript of my correspondence with the project group's doctors in Denmark.
Documentation about the experiment
As documentation for the majority of the claims and information I have provided above so far, below is an email correspondence regarding the experiment.
Below is the full unedited correspondence with two doctors hired to answer questions about the trial: However, I have marked important answers in turquoise.
correspondence with doctor Anne Marie from the DAN-COMBO project group.
Subject: Re: Possibility to participate in a trial with a combination vaccine against influenza and COVID-19
My questions to Professor Tor Biering-Sørensen:
Date: September 18, 2026
Hello Professor Tor Biering-Sørensen
I have been invited to participate in the above experiment.
Before I say yes, I have a few questions that I hope to get answers to.
· Is the combination vaccine in the trial an mRNA vaccine like Moderna's COVID19 vaccines?
· Is there a risk of getting myocarditis?
· Does it contain the same lipid nanoparticles as Moderna's original mRNA C19 vaccine?
· How quickly are these lipid nanoparticles excreted from the body and how?
· Have placebo studies ever been conducted with material from the specific manufacturing process by which this combo vaccine is manufactured?
· Is there a risk of getting endotoxins as impurities in the injection?
· Is it true that the vaccine is made by cultivating coliform bacteria?
· You refer to some studies that suggest they are safe. Can I please be sent the studies you refer to (possibly links)?
· What happens if I get a serious side effect?
· Will Moderna compensate me in that case?
· Who owns the Danish Doctors' Vaccination Service?
I look forward to a prompt response.
Kind regards, Jeanne Rungby
Reply date: September 21, 2026
Email:
Dear Jeanne, Thank you for your inquiry. I have tried to answer your questions below:- Yes, the combination vaccine (mCombriax) uses mRNA technology for both components, both the influenza and the COVID-19 part, like Moderna's other COVID-19 vaccines.- Inflammation of the heart muscle or pericardium (myocarditis/pericarditis) is a known, very rare side effect of mRNA COVID vaccines like Spikevax (fewer than 1 in 10,000). It is not listed as a side effect for the combination vaccine, but a similarly rare risk cannot be ruled out.- Yes, mCombriax uses the same types of lipid nanoparticles as Spikevax: SM-102, cholesterol, DSPC and PEG2000-DMG.- The lipids in the nanoparticles (cholesterol, phospholipids, SM-102 and PEG-lipid) are part of the body's normal metabolism and are excreted primarily via the liver, while the PEG-lipid is also excreted via the kidneys. The majority of the lipid components are broken down or excreted within 1-3 weeks - No, the combination vaccine (mCombriax) has only been tested with active control – not against placebo . However, material from the same manufacturing process and platform (lipid nanoparticles and mRNA technology) has previously been tested in large placebo-controlled studies when Moderna's original Covid-19 vaccine (mRNA-1273/Spikevax) was approved. - The DNA template behind the mRNA is produced using E. coli bacteria, which is standard for mRNA vaccines. The finished product does not contain any live bacteria. There may be very small residual amounts of endotoxins, but each batch is tested and must be below the established, statutory limits , just like for all other injectable medicines. - The studies behind the approval of mCombriax are: 1. Spergel AKR et al. Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA. 2025. https://jamanetwork.com/journals/jama/fullarticle/2833668 (PMID: 40332892) 2. Spergel AKR et al. mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial. Nature Medicine. 2025. https://www.nature.com/articles/s41591-025-03591-0 (PMID: 40102593) 3. Kostanyan L et al. Safety and durability of influenza and SARS-CoV-2 antibody responses through 6 months after a single dose of mRNA-1083, a multicomponent influenza and COVID-19 vaccine, in adults ≥50 years. 2026. https://pmc.ncbi.nlm.nih.gov/articles/PMC13224755/ - If a participant experiences a serious side effect, a physician will assess whether it may be due to the vaccine. If there is a serious and unexpected side effect, it is reported to the authorities – the Danish Medicines Agency and the European Medicines Agency (EMA) – via the European safety system EudraVigilance. In addition, a comprehensive safety report is sent to the authorities every year. - As a participant in the trial, you are covered by the Patient Compensation Scheme – it is the Danish patient compensation scheme, not Moderna, that handles any compensation claims. - The Danish Doctors' Vaccinations Service is owned by the parent company European LifeCare Group, which was taken over by the German private equity fund Findos in 2024. Kind regards, Anne Marie, physician On behalf of the DAN-COMBO project group
Dear Anne-Marie.
Thank you very much for your thorough answers, which were important to me. The answers gave rise to a larger investigation and some more in-depth questions, which I hope you can answer before I decide to participate in the experiment.
1. Regarding the influenza part of the combination vaccine
When reviewing your source no. 1 ( JAMA, Spergel et al, PMID: 40332892, incl. Supplement page 28, section 2.3.1) and source no. 2 (Nature, Spergel et al, PMID40102593) it is clear that the influenza part of the vaccine (mCombriax, mRNA1083) is the same as mFlusiva (mRNA1010), which was recently approved by the FDA.
Despite this approval, the CDC has failed to recommend mRNA-1010 for the 2026 and 2027 seasons. This is surprising.
It also appears that the JAMA study by Spergel et al only compares mRNA-1083 and mRNA-1273 (over 65 years) plus inactivated high-dose influenza vaccines without a placebo control group . 1885 and 1883 real participants (antibody measurements) were over 65 years of age. There is no description of those who were excluded from the trial, including why. The observation period was up to 29 days. Measurement parameters were short-term antibody responses without subclassification . There was no long-term monitoring and no prospective Troponin T measurement or other markers. The study was paid for, designed and completed by Moderna, which will probably make a lot of money on this mCombriax if it is approved.
A new peer-reviewed study based on the FDA's own data regarding mRNA1010 vs. other flu vaccines ( https://journalofindependentmedicine.org/articles/v02n05a07/ ), was re-evaluated by independent researchers, who found the following results:
· 155% increased risk of unexplained death in the mRNA-1010 group (mFlusiva).
· 515% increased risk of disability in the same group.
In this study, the new mRNA-1010 was compared to traditional flu vaccines. None of the pivotal studies included a placebo group (saline alone). Omitting a placebo group is not, in my opinion, a fair and balanced analysis. If one had compared it to a control group that had received a true placebo (saline or similar), the results would probably have looked even worse.
Dr. Jessica Rose ( https://jessicar.substack.com/p/the-new-mrna-1010-mflusiva-injectable?r=1i19zf&utm_medium=ios ) has made a hypothetical representation of the results of the ideal study based on the above data, where a placebo group is included in the study:
It looks like this:
This puts the results into perspective. You can think about that a little. We don't know the reality of a real placebo group because it wasn't done.
Quote from the study by Hulscher et al:
“All reported adverse events occurred more frequently with mFLUSIVA (mRNA1010) than with the standard-dose comparator. Overall, reported adverse events occurred in 75.7% of mFLUSIVA recipients versus 46.7% of comparator recipients, and grade 3 systemic reactions occurred in 5.5% versus 0.9% (RR, 6.15; 95% CI, 4.11–9.20). Unexplained deaths occurred in 23 mFLUSIVA recipients versus 9 comparator recipients (RR, 2.55; 95% CI, 1.18–5.52)… Only one autopsy was performed in the entire clinical program, in the comparator group. The relative vaccine efficacy against RT-PCR-confirmed influenza-like illness was 26.6% (95% CI, 16.7–35.4). NNV (numbers needed to vaccinate) was 137 for one confirmed case of illness, 1003 for one visit to a higher level of care, and 5017 for one hospitalization. For each hospitalization avoided, approximately 1454 additional reported adverse events, 233 additional grade 3 systemic reactions, and 2 additional unexplained deaths were observed. No influenza mortality endpoint was specified, collected, or reported.”
An extreme risk profile!
In addition, only 1 autopsy was performed in the control group. When the 23 unexplained deaths in the mFlusiva (mRNA-1010) group were not autopsied, it seems unscientific.
Based on this independent study, the mRNA-1010 vaccine has significant adverse effects. It must be assumed that the same applies to the new combination preparation (mCombriax), as it contains the same influenza vaccine (mRNA1010). Thus, there is a large discrepancy between the two interpretations of the same mFlusiva study.
You write:
“Studies suggest that the combination vaccine provides a better immune response for both influenza and COVID19 than the current ones”
That sounds really good - and safe. However, according to Supplements 3 (the JAMA study), approximately 1% experienced serious side effects, including 2 who developed heart disease.
However, the study by Hulscher et al showed the following:
“ mFLUSIVA demonstrated minimal absolute clinical benefit, while resulting in significantly greater reactogenicity and a significant unconfirmed signal of mortality. The extreme risk-benefit profile argues against continued approval of mFLUSIVA and argues for reconsideration of its marketing authorization.”
2. Regarding the risk of myocarditis and pericarditis in connection with Spikevax (mRNA1273) and mRNA technology in general.
You write that the risk of "Spikevax is less than 1 in 10,000 and that a similarly rare risk cannot be excluded with the combination vaccine."
In a prospective study of healthcare professionals receiving mRNA1273 conducted by Buergin et al from 2023, a risk of 1 in 35 was found. The risk was assessed based on Troponin T measurements in all participants:
Quote: “COVID-19 mRNA vaccine-related myocardial injury was defined as an … increase in hs-cTnT (Troponin T) above the sex-specific upper limit of normal … on day 3, without evidence of an alternative cause, regardless of symptoms, ECG, or cardiac imaging abnormalities.
In the overall cohort that received the mRNA-1273 booster dose, hs-cTnT concentrations (day 3) were significantly higher compared with matched controls (median 5 [IQR 4–6] ng/L vs 3 [IQR 3–5] ng/L, p < 0.001).
When using gender-specific (normal) cutoff values for myocardial injury assessment, myocardial injury associated with the mRNA-1273 booster vaccine occurred significantly more frequently in women than in men (3.7% vs. 0.8%). This is in marked contrast to the gender distribution of vaccine-associated myocardial injury associated with clinical myocarditis following the first and second vaccinations, which was detected by passive surveillance and occurred predominantly in young men. The median age of participants who developed mRNA-1273 vaccine-associated myocardial injury was 46 years.”
In March 2023, Yonker et al. published a consecutive study of 16 teenagers who were hospitalized with chest pain, elevated Troponin T, and newly diagnosed with Myocarditis (inflammation of the heart muscle) shortly after the first and second doses of the COVID19 mRNA vaccines. The control group consisted of 45 age-matched vaccinated teenagers without symptoms. In the group of teenagers hospitalized with myocarditis, the authors found a highly significant occurrence of free spike protein in the bloodstream compared to the control group. Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC10010667/
Follow-up over a longer time frame (10 years) may reveal clinically important findings that are not apparent in the acute phase. Te et al., (2017) showed in a large national cohort study with a follow-up time of approximately 10 years that patients with a history of acute myocarditis had an increased risk of life-threatening ventricular tachycardia, implantation of a cardioverter-defibrillator, and cardiovascular mortality. Although the study had no association with COVID-19 vaccination and cannot establish that vaccine-associated myocarditis carries the same long-term prognosis, it illustrates why conclusions that myocarditis is “mild and transient” cannot be based on short-term follow-up alone.
On September 21, 2022, a peer-reviewed study was published in the Lancet based on reports to VAERS about myocarditis for the age group 15 – 22 years. ( https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00244-9/fulltext ). The condition of these young people was followed up 3 – 7 months after the report. This is a comprehensive study, the most important findings of which were that half (178) of these (357), most of whom were boys/young men (88%), still had symptoms attributable to myocarditis after 3 – 7 months (chest pain, fatigue, shortness of breath, and palpitations). A subgroup of 151 children/young people from the same study underwent cardiac MRI scanning (MRI) with contrast, which is the most accurate and sensitive objective examination to detect scar tissue in the heart. 81 (54%) had one or more abnormalities on this scan, indicating permanent changes in the heart.
These are very serious findings.
Another important finding was that out of a subgroup of 100 children/adolescents who had reduced cardiac pumping function of less than 50% of normal at the first examination (echocardiography), 33% still had reduced cardiac pumping function of less than 50% at the follow-up 3 - 7 months later.
The study suggests that active, prospective and thorough long-term follow-up with the right examinations will find significantly more heart damage after these mRNA vaccines than previously assumed, based on retrospective post-marketing studies.
A recent article by Ophir et al ( https://www.excli.de/excli/article/view/9596 ) reveals that on February 28, 2021, the Israeli Ministry of Health warned health authorities (CDC, FDA and EMA) on both sides of the Atlantic about a new serious signal of heart problems associated with Pfizer’s COVID19 mRNA vaccine. This warning was based on an internal drug monitoring report by the Israeli Ministry of Health. In the final version of this dataset from May 9, 2022, myocarditis or pericarditis occurred in 250 of 531 hospitalization reports, almost half . Among patients under 30 years of age, it occurred in 151 of 211 reports, more than 70% .
Despite this safety signal, which the EMA was aware of several months in advance, doctors in Denmark were only warned (via e-Boks) in June 2021, after mRNA vaccination of young people had begun. And here the designation of myocarditis was changed to “mild and transient”. This designation of myocarditis as “mild and transient” appears undocumented.
The article provides a thorough review of myocarditis and other heart diseases in connection with mRNA vaccine technology. I recommend you read it to the end.
A peer-reviewed study from October 2025 ( https://pubmed.ncbi.nlm.nih.gov/41164857/ ) investigated molecular mimicry between an epitope on the spike protein and proteins in heart muscle cells, leading to acute myopericarditis. The production of certain cytokines occurred only in people who had been vaccinated with the mRNA vaccine, and not in patients with COVID-19. The researchers also conducted crucial experiments in mice that confirmed their own findings.
The researchers thus found that combined adaptive immune mechanisms mediate cardiac damage after COVID19 mRNA vaccination.
This article thus provides an explanation of why myocarditis occurs after mRNA vaccines using mRNA technology.
Overall, several studies, including prospective studies, suggest that the claim that “benefits outweigh disadvantages” is debatable when it comes to myo- and pericarditis with mRNA vaccines against COVID-19.
Questions regarding myocarditis and pericarditis:
1. Are there plans to perform Troponin T measurements before (baseline) and after vaccination with mCombriax on day 3, as well as later?
2. Are there also plans for long-term follow-up (longer than 28 days), and for how long?
3. There is a very large gap between an incidence of 1 in 35 and less than 1 in 10,000. How would you explain this difference?
4. What is the reason the cardiac department is involved in the study?
5. What can actually be done for the subject if myocarditis or other heart disease occurs as a result of the combination vaccine?
6. Can heart muscle heal if scar tissue has formed?
7. Is there a diagnostic code that describes the condition “Myocarditis due to immunization with mRNA vaccine”?
8. If so, what ICD diagnosis code number does it have (I haven't been able to find it)?
9. If there is no diagnosis code as a result of immunization after mRNA vaccine, does this mean that in the case of cardiac death as a result of the combination vaccine, it remains unexplained and thus does not appear in the data as a death from the vaccine?
10. Do you plan to perform autopsies on everyone who dies after vaccination?
11. In the event of an autopsy, will immunohistochemistry be used to detect the vaccine-specific proteins in tissue samples from organs?
12. If no, how can it be documented with certainty that the vaccine was - or was not - the cause of death?
3. Regarding the Lipid Nano Particles in the vaccine.
You write: “Yes, mCombriax uses the same types of lipid nanoparticles as Spikevax: SM-102, cholesterol, DSPC, and PEG2000-DMG.”
As well as:
"The lipids in the nanoparticles (cholesterol, phospholipids, SM-102 and PEG-lipid) are part of the body's normal metabolism and are excreted primarily via the liver, while the PEG-lipid is also excreted via the kidneys. The majority of the lipid components are degraded or excreted within 1-3 weeks"
Question:
1. Are the fats (cholesterol, phospholipids, SM-102 and PEG-lipid) all naturally occurring fats in the body?
2. If no. Which fats are not natural?
3. What is the half-life of fats that are not natural in animals or humans (incl. documentation/reference)?
4. Is it true that these fats are designed to cross various natural barriers such as the blood-brain barrier? Certain distribution studies on laboratory animals showed distribution to the liver, ovaries and brain.
5. Experiments on mice ( https://mariagutschi.substack.com/p/the-wang-study-on-lnps-and-cancer?r=1i19zf&utm_medium=ios ) have shown that certain combinations of LNPs have triggered:
· Inflammatory activity
· Cell death and muscle cell necrosis and thereby release of mitochondrial DNA
Metastatic risk
Does this also apply to the fats mentioned in the combination vaccine?
6. Have there been any human trials (with a longer time interval than 48 hours) that show that the fats in mCombriax do not have harmful effects? The harmful effects could be:
· Changing the function of cell membranes
· Recirculation of the lipids in vesicles or endosomes and the consequences of this?
· Where the fats end up after 48 hours.
A new review article by Seger et al ( https://doi.org/10.1016/j.apsb.2026.07.001 ) analyzes LPN at a detailed level. The authors conclude:
" LNP metabolism cannot simply be considered as
a source of degradation metabolites, but also as a potential source of
reactive, bioactive lipid intermediates that contribute to sustained
inflammatory signaling or stress signaling”
4. Regarding the manufacturing process
You write:
“No, the combination vaccine (mCombriax) has only been tested with active control – not against placebo. However, material from the same manufacturing process and platform (lipid nanoparticles and mRNA technology) has previously been tested in large placebo-controlled studies when Moderna’s original Covid-19 vaccine (mRNA-1273/Spikevax) was approved.”
At first glance, it seems to me insufficient that material from a manufacturing process that triggered a different protein in the body than the actual proteins triggered via the combination vaccine can be used as sufficient assurance that the new proteins do not have a harmful effect when they are produced by the body's cells after uptake of mRNA, despite the same manufacturing method. The same applies to the biological in vivo effect of the combination of lipids and proteins.
In the case of Pfizer's COVID19 mRNA vaccine, we know for sure that Pfizer changed the manufacturing process of the vaccine (Comirnaty) after approval.
Process 1 (used for phase 3) was based on a pure production via the PCR method while process 2 was produced by culturing E-Coli bacteria. It was precisely the switch from process 1 to process 2 – after approval – that entailed a risk of impurities in the form of plasmid DNA parts and endotoxins from the bacterial membrane.
Material from this process 2 was never tested in placebo-controlled trials, which was confirmed by the Danish Medicines Agency in a document access of 12 August 2024 ( https://www.wch-scandinavia.org/post/lægemiddelstyrelsens-svar-på-forespørgsel-ved-proces-2-comirnaty ). The planned comparability studies were also not completed, which was in violation of the trial protocol ( https://cdn.clinicaltrials.gov/large-docs/28/NCT04368728/Prot_000.pdf ).
Question:
1. Was material from the approved mRNA-1273 (Spikevax) vaccine tested using a pure PCR-based manufacturing process in the phase 3 trials, which included a control group that received pure placebo (saline)?
2. Was the manufacturing process of the commercial mRNA1273/Spikevax changed to E-Coli-based, which entailed the mentioned risks of contamination with endotoxins and plasmid DNA - after approval?
3. If yes, were randomized phase 3 placebo trials conducted again with material from the commercial product (mRNA-1273/Spikevax) based on modified E-coli?
4. If no to question 3, then it is not the same manufacturing process and in that case there are no pure placebo-controlled studies for comparison. Am I right?
5. Regarding damages and compensation.
You write:
"As a participant in the trial, you are covered by the Patient Compensation Scheme - it is the Danish patient compensation scheme, not Moderna, that handles any compensation cases....Danish Doctors' Vaccinations Service is owned by the parent company European LifeCare Group, which was taken over by the German private equity fund Findos in 2024."
1. Why are Danish taxpayers the ones who have to pay in the event of damage after these vaccines and not the companies responsible for the trial?
2. Are Moderna and the Danish Doctors' Vaccination Service completely exempt from liability in the event of damage? Or are there exceptions?
3. Are there any publicly available agreements that clearly show that they are free from liability? Which ones?
Conclusion:
The above studies and the circumstances described have cast doubt on the benefit of this combination vaccine, mCombriax, that I have been offered. It may well be that I have misunderstood these studies.
I know these are a lot of questions. However, I am sure that I am not the only one among Danes aged 65 or over who has similar concerns.
I'm happy to share your answers with the outside world (and my investigation) so that any doubts can be put to rest once and for all.
I therefore kindly request answers to my questions relatively quickly.
If there is no answer, I will ask the questions to health authorities, the Danish Regions and the Minister of Health in the hope of an answer.
Thank you
Jeanne Rungby
Dear Jeanne,
I have tried to answer your detailed questions below:
The trial uses registry-based safety surveillance via national health registries and does not include systematic troponin measurement. In addition to active surveillance during the first 6 weeks, all participants are followed via the registries for up to 20 years for long-term effects and safety, including infections, hospitalizations and death. The trial is anchored in a cardiovascular research environment, and hospitalization for cardiovascular disease is included as one of the study endpoints.
The difference between the two figures for the incidence of myocarditis is due to the fact that they measure different things. Buergin et al. measured a transient, mostly asymptomatic increase in troponin (a biochemical myocardial effect, not clinical myocarditis), while the figure of less than 1 in 10,000 applies to actual clinical myocarditis or pericarditis. Different definitions therefore give very different frequencies. Should a participant develop myocarditis or other heart disease, it is treated in the public health service according to current cardiological guidelines. Many cases heal without lasting damage, while actual scar tissue in the heart muscle is generally permanent .
In terms of registration, there is no single diagnostic code for "myocarditis due to mRNA vaccine". Myocarditis is coded with its own diagnostic code (ICD-10 I40/I41). However, this does not mean that such cases become invisible: the event itself is registered, and a possible causal relationship is assessed by medical record review as part of our safety monitoring and is reported as a serious adverse event to the authorities if it is considered related to the vaccine . Routine autopsy of all those who die after vaccination is not included in the trial, and immunohistochemistry is not a fixed part of the study; any autopsy follows common practice. In the individual case, complete certainty about the cause can rarely be achieved – but the strength of the trial design is precisely that approximately 205,000 people in each group are compared by random selection, so that it can be discovered at the population level if a vaccine increases the risk of, for example, heart disease or death.
Of the four fats, cholesterol is naturally occurring in the body, and DSPC is a phospholipid of the same type as the body's own cell membranes and is broken down by the same pathways. SM-102 and the PEG lipid (PEG2000-DMG), on the other hand, are synthetic and do not occur naturally in the body ; they are included to protect the mRNA and transport it into the cells.
For the two synthetic lipids, excretion has been investigated in preclinical pharmacokinetic studies submitted to and assessed by the authorities. SM-102 is broken down by the body's enzymes (esterases) and excreted from the blood with a half-life of the order of days, while the PEG lipid is cleared more rapidly. The majority of the lipid components are broken down or excreted within approx. 1-2 weeks. The documentation can be found in the EMA's public assessment report for Spikevax (section on non-clinical pharmacokinetics):
The lipids are not designed to cross the blood-brain barrier, but to deliver mRNA into cells near the injection site. In animal studies, the vast majority was found, as expected, at the injection site and in the liver, while only very small amounts were detected in other organs, including the ovaries and brain . No evidence of accumulation or damage was found at these low levels.
Regarding the animal studies with LNPs: preclinical findings depend strongly on the dose, route of administration and the specific formulation. Often much higher doses or different administration than in vaccination are used, and they cannot therefore be directly transferred to the very small amounts of lipid given in a vaccine injection. The individual lipids have not been studied in isolation in humans; their safety is assessed as part of the finished vaccine, the overall safety of which has been documented in clinical trials and in the subsequent monitoring of many millions of doses given over several years.
Moderna's original COVID-19 vaccine (mRNA-1273/Spikevax) was tested in a large randomized phase 3 trial (the so-called COVE study with approximately 30,000 participants), where the control group received saline as a placebo. This was therefore a pure placebo-controlled trial for this vaccine.
When scaled up to commercial production, the DNA template from which the mRNA is made is produced using plasmid grown in E. coli bacteria. This is the standard method for mRNA vaccines. The finished product contains no bacteria; it is purified and there are strict, legally required requirements for residual content of both DNA and endotoxins, which must be below set limits.
No new placebo-controlled phase 3 trial was conducted specifically for the scaled-up product. Changes in the manufacturing process are instead handled through comparability studies (analytical quality studies) to document that the product is consistent with the one on which the effect was demonstrated. This is the recognized and legally required approach for all biological medicines – efficacy trials are not repeated for each production change.
As a participant, you are covered by the Patient Compensation Scheme, which is a compensation scheme without any claim of fault . The purpose is that a patient who is injured in the Danish healthcare system (including in a research trial) can have a compensation case processed in a simple and accessible way without having to take legal action against a company themselves. It is therefore a scheme designed to benefit the patient.
The fact that compensation can be sought through the Patient Compensation Scheme does not in itself mean that the manufacturer is exempt from any liability. The general rules on product liability therefore continue to apply. Questions about any specific agreements on the distribution of liability and their public availability are legal matters, which I would refer you to address to the trial sponsor or the relevant authorities.
I hope the above answers your questions. Participation in the study is of course completely voluntary, and it is solely your decision whether you wish to participate.
Kind regards,
Anne Marie, doctor
On behalf of the DAN-COMBO project group
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