Only a single dose
By Dr. Jeanne A. Rungby, MD, Specialist
Drawing by Lars Bo Appel
Translated from Danish to english with AI.
Presumably, all Danes aged 65 and over have currently received an invitation to participate in the DanCombo trial via Digital post. To include 410,000 elderly people, it would be normal to invite 1.3 – 4 million elderly people. We have approx. 1.3 million over 64 years of age in Denmark.
This is an experiment on a very large population group.
This article only concerns what information the invitation to the DanCombo trial contains and whether this information can be said to be correct. It concerns ethical considerations and whether the law has been complied with, as well as two objections to the Scientific Ethics Committees in the Capital Region of Denmark.
Background information about the Danish DanCombo trial - a new vaccine trial offered to seniors over 64 years of age in Denmark - is provided here: 1,2,3 "Dirty trot" , Trial Site News article on the subject and Children's Health Defense's article
Briefly: In the DanCombo trial, the elderly are offered a combined mRNA vaccine consisting of Moderna's mRNA-based new influenza vaccine with at least 3 mRNA codes for influenza proteins and their Spikevax COVID-19 mRNA vaccine in one injection. The combined vaccine is called mCombriax. These vaccines are also delivered encapsulated in four lipids, two of which are foreign to the human body.
Contrary to what one might expect, the study does not compare the group receiving the mCombriax vaccine to a group receiving saline. Instead, it compares it to a group receiving the mRNA COVID-19 Omicron vaccine (Spikevax) plus a high-dose traditional combination vaccine against four influenza antigens, administered in two injections on the same day. The mRNA COVID-19 Omicron vaccine also contains the same four lipids.
The experiment started on October 1st of this year .
The experiment is mentioned in the news broadcast on DR 4 .
Tor Biering-Sørensen, professor and chief physician at Herlev-Gentofte Hospital, is leading the trial with the combination vaccine. He says:
"The vaccines are approved and thoroughly tested, so you can definitely feel safe participating ."
The article in DR News states:
"The advantages of administering the vaccines as a single dose include avoiding having to inject people twice; it can save on plastic and reduce the need to transport twice as many vaccines."
Half of the study participants will receive one dose of the combination vaccine, while the other half will receive two doses, as is currently the case.”
The article in DR news does not report that the experimental vaccine contains at least 4 (possibly 5) mRNA codes, corresponding to 4 mRNA vaccines in one shot.
Professor Tor Biering-Sørensen (TBS) from the Herlev-Gentofte Heart Department is overall responsible for the trial, to which Moderna has donated 140 million kroner in addition to the vaccines.
TBS markets this trial as a matter of convenience for the elderly by only getting one injection instead of two - and the environmental concerns are understandable.
In the invitation itself to the elderly citizens, TBS and the other senders (chief physicians) have similarly completely avoided informing the participants that mCombriax contains at least 4 mRNA codes for proteins that are foreign to the body? Proteins that will be produced by the body's own cells, which are taken over by the vaccine (like a virus).
What does it mean when TBS says that the vaccines are thoroughly tested?
Have Moderna or the authorities tested or will they test how many of these foreign proteins will be produced, for how long, and how these proteins may affect the body. For example, has it been investigated whether they can damage the heart or cause blood clots?
The answer is no.
Have they or will they test how long the mRNA codes circulate in the body?
Neither, no.
Have they or will they conduct blood tests (e.g., troponin T), ECGs, cardiac MRI scans, autopsies with a special focus on the fingerprints of these vaccines, immunohistochemistry, and collect systematic data before and after injection?
The answer is no.
Have they tested the vaccines in question against placebo (saline)?
No.
Have they tested what happens to the alien fats in the body?
No.
The above is not a complete list of what has not been studied in connection with mRNA technology. You can read more about this in a completely new review article that reviews the risks and unresolved issues in relation to the safety of mRNA technology. 5 This review article contains 211 references, and is thus solidly substantiated.
According to 2 articles provided by the DanCombo trial team, antibodies have been measured within a very short period of time (28-29 days). 6,7 In another article, antibodies have been measured for up to ½ year. 8 It is probably these three articles that TBS refers to when he states that “The vaccines have been thoroughly tested”. 6,7,8
Measuring antibodies (“immune response”) is not the same as assessing efficacy and safety, as antibodies can be divided into subgroups (subclasses) with different functions in the body.
An increase in IgG4, for example, is very concerning and associated with weakened immune systems (immune tolerance) and cancer (IgG4-related disease).
An increase in antibodies is therefore not the same as safe and effective.
Why expose so many elderly people in Denmark to risk?
It would probably be fair to call the information given to participants in the invitation and in DR news misleading.
Who are the actual senders of the invitation to participate in the experiment?
The letterhead on the invitation includes the logos of Denmark's 5 public, taxpayer-funded university hospitals in the 5 regions; namely Aarhus, Aalborg, Odense, Region Zealand and the Capital Region.
A senior physician from each University Hospital has signed with title and affiliation to the University Hospital.
However, access to all 5 hospital managements has shown that at least 3 out of 5 hospital managements have nothing to do with the planning of this trial.
No special examination programs or diagnostic codes have been implemented, nor have special instructions or increased monitoring of patients included in the trial.
There is therefore no collaboration between these 5 hospitals.
Why was it necessary in the invitation to pretend to be a public collaboration between these hospitals?
Aarhus University Hospital states:
"Carsten Schade Larsen's participation in DAN-COMBO is in his function as chief physician in the Danish Doctors' Vaccination Service and is not part of his employment or work duties at Aarhus University Hospital. Although he is listed in the trial's invitation letter with his title and affiliation with AUH, the hospital is not participating in the trial."
Carsten Schade Larsen, CSL, who is chief physician at the Danish Doctors' Vaccination Service, a private foreign-owned company, is employed 14.8 hours/week (secondary employment) at Aarhus University Hospital.
His primary workplace is apparently the Danish Doctors' Vaccination Service, a privately owned company that is conducting the actual trial.
CSL has also received significant sums of money from various pharmaceutical companies for the purpose of educating doctors and advising politicians, as stated in the Danish Medicines Agency's list of individuals who receive financial support from companies.
One may therefore well doubt where CSL's loyalty lies.
The same applies to Professor Tor Biering-Sørensen (TBS), who has also received significant funding from the pharmaceutical industry.
In addition to TBS's permanent full-time position in Herlev/Gentofte, TBS has the following side jobs: Steno Diabetes Center: 44 hours/month. University of Copenhagen research 59 hours/month. He also works 2 hours/month for Sanofi and 1 hour/month for Pfizer. According to the Danish Medicines Agency's list, TBS has received DKK 92,227 from Sanofi alone in 2026 and DKK 335,700 from Pfizer alone in 2026. Moderna is also on the list. In total, to date, TBS has received DKK 560,000 in 2026 alone from various pharmaceutical companies within the vaccine industry.
Seen in this light, one may be in doubt about who the actual senders of the invitation to the DanCombo trial are.
It appears that the sending group wanted to give the trial participants a false impression of overall public control and security in the form of - apparent - collaboration between the University Hospitals.
Yesterday, the Medical Ethics Committees of the Capital Region of Denmark received a letter from me, in which I state these two complaints. I also point out a number of ethical issues that I believe should have been examined more closely before they gave approval.
Below is my letter to the Scientific Ethics Committees in full.
Another case currently pending before the scientific ethics committees in the Capital Region regarding the DanCombo trial.
Informed consent to participate in the trial requires correct information.
My colleague, clinical immunologist Dr. Kim Varming, sent a letter to the scientific ethics committees on September 30, before the start of the trial, asking them to conduct a rapid assessment of the missing information about the mRNA content in the influenza part of the experimental vaccine mCombriax. The letter is provided below.
The committee members seem to still be considering the matter at the time of writing. It is assumed that approximately 200,000 Danes have signed up for the trial under the false assumptions described at this time.
My letter to the Scientific Ethics Committees:
October 26, 2026
To the Scientific Ethics Committees for the Capital Region of Denmark
Regarding the DanCombo trial . A phase 4, pragmatic, randomized trial to investigate the effect of an influenza/COVID-19 vaccine (mCombriax [mRNA-1083]) in people ≥65 years of age (DAN-COMBO) EU CT number: 2026-526720-49-00 Participant information: Version 1.3 of September 9, 2026
Goal: To include 410,000 participants in the trial.
My inquiry concerns two topics regarding the invitation to participate in the DanCombo trial .
1. Neither in the invitation, on the associated website nor under questions and answers does it appear that the influenza part of the vaccine is mRNA-based. Nor does it appear that the influenza part contains mRNA codes for 3 different antigens (hemagglutinin glycoproteins) in addition to the mRNA code for Omikron XBB.1.5
This should be clear to ordinary Danes, without special medical insight.
It is stated on the invitation:
“Therefore, the purpose of this trial is to investigate how a combination vaccine against influenza and COVID-19 works compared to the current vaccinations, which are given as separate shots.”
If you click on the link to the website for the trial, which is referred to in the invitation, https://www.minvaccination.dk/dan-combo-2026c/ , you will be taken to a private, foreign-owned website belonging to the Danish Doctors' Vaccination Service, DLVS.
It states that the purpose is "to investigate whether a combination vaccine against influenza and COVID-19, given as one shot, can provide equally good protection against disease compared to current vaccines, which are given as separate shots."
It also states that " a combination vaccine can make vaccination simpler and involve fewer injections, which may be experienced as more convenient and cause less discomfort."
"If you choose to participate, you will be randomly assigned to one of two groups:
· One group will receive a combination vaccine against influenza and COVID-19 (one shot).
The second group will receive a high-dose influenza vaccine and a COVID-19 vaccine as two separate shots.”
The information focuses too much on the difference between the comfort of receiving one plug versus two without explaining the significant difference between the products.
It is therefore not clear that the combination vaccine mCombriax is based on mRNA technology for both the Influenza part and the Covid part.
Since many people would like to receive traditional vaccines but not mRNA-based vaccines, this should be made clear.
In particular, it should be noted that the Influenza part contains 3 formulations of mRNA codes for subclasses of influenza in addition to the spike protein code. This is effectively 4 mRNA vaccines in one shot.
2. The invitation itself is designed as a letter bearing the logos of all 5 regions' university hospitals, and signed by a professor and 4 senior physicians, who with titles and affiliations represent the 5 public university hospitals in Denmark, namely Aarhus University Hospital (AUH), Aalborg University Hospital, Odense University Hospital (OUH), Zealand University Hospital and Herlev-Gentofte hospitals.
It has emerged from access to documents that at least 3 of these hospitals (OUH, AUH and Aalborg UH) apparently disclaim responsibility for the DanCombo trial.
The following appears from the Danish Doctors' Vaccination Service's website, as part of the invitation. “Follow-up based on passive reporting.
Physician responsible for the trial: Professor Tor Biering-Sørensen, Chief Physician and Trial Leader Cardiovascular Research, Gentofte Hospital Gentofte Hospitalsvej 8, 3.th. 2900 Hellerup E-mail: hgh-fp-dan-combo@regionh.dk
Carsten Schade Larsen Senior Physician
in infectious diseases Aarhus University Hospital
Lykke Larsen Senior Consultant in Infectious Diseases Odense University Hospital
Lothar Wiese Senior Physician in Infectious Diseases Zealand University Hospital
Michael Dalager-Pedersen Senior Physician in Infectious Diseases Aalborg University Hospital”
Odense University Hospital, OUH, writes the following (excerpt):
"6. Personal liability for injuries to trial participants"
“OUH has not identified documents regarding the division of responsibility in the trial.
7. OUH's liability for injuries to trial participants
The vaccinations in DAN-COMBO do not take place at OUH. The trial is coordinated from Herlev and Gentofte Hospitals.
OUH has not identified documents regarding OUH's role and responsibility in the trial.
17. Special diagnostic tests
OUH has not established any special research programs or analyses regarding mCOMBRIAX or other mRNA vaccines.
Doctors are subject to the general rules on reporting suspected adverse reactions to the Danish Medicines Agency.
OUH has not received any special instructions regarding mCombriax or other mRNA vaccines.
18. Instructions regarding death and autopsy
OUH has not identified separate instructions regarding deaths following vaccination with mCOMBRIAX.
Aarhus University Hospital, AUH writes the following :
Senior Physician Carsten Schade Larsen's "participation in DAN-COMBO takes place in his function as chief physician in the Danish Doctors' Vaccination Service and is not part of his employment or work duties at Aarhus University Hospital. Although he is listed in the trial's invitation letter with his title and affiliation with AUH, the hospital is not participating in the trial. Vaccination Center Aarhus, which is run by Infectious Diseases at AUH, is also not participating in DAN-COMBO. Furthermore, the work duties in the vaccine center are not part of Carsten Schade Larsen's position at AUH. "
It also appears that Carsten Schade Larsen works a total of 14.80 hours per week at AUH. The rest of the working hours are apparently spent as chief physician at the Danish Doctors' Vaccination Service.
One must wonder why Carsten Schade Larsen does not sign as chief physician of the Danish Medical Association's Vaccination Service on the invitation to the trial participants and why the DLVS logo is not used on the invitation, when his employment at AUH is in the nature of a side job.
Aalborg University Hospital writes as follows:
Regarding the project
"The chief physician (Michael Dalager-Pedersen) is a member of DAN-COMBO's scientific steering committee and co-signs the invitation to the participants. The sponsor is the Department of Heart Diseases, Herlev and Gentofte Hospital. This is a clinical drug trial with medicine in Denmark. The project is therefore subject to special legislation, which is why the project must be approved by the Scientific Ethics Medical Committees. We refer to you contacting the sponsor with specific questions regarding the organization of the project."
The above answer must be interpreted as meaning that Aalborg University Hospital is not involved in the planning or implementation of the DanCombo trial.
No final response has been received from the University Hospital in Region Zealand.
By using the logos of the university hospitals and the affiliation of the responsible physicians to these university hospitals on the invitation, participants are given a false impression of overall coordination, overall authority overview and independent guarantee of safety at DanCombo.
This gives the invitation the false character of a public health offer. coordinated between the University Hospitals , which is not the case.
This impression is reinforced by using Digital Post to send out the invitation.
Excerpt from the Criminal Code:
“It follows from the Criminal Code that a document is false when it does not come from the issuer that has been stated, or when the document does not have the content that the issuer had originally inserted. If someone uses a false document to cause confusion for their own benefit, then that person can be punished for forgery under Section 171 of the Criminal Code. ”
This is stated at the end in a link to the DLVS website regarding financial conditions at DanCombo.
“The trial is funded by the pharmaceutical company Moderna, which has developed the mCombriax® (mRNA-1083) combination vaccine, and which therefore may have a financial interest in a positive outcome of the trial. Moderna is a co-sponsor of the trial, which in this trial means that Moderna has contributed to developing the trial protocol and that in the event of side effects, these are reported to Moderna. Moderna has donated the vaccines and financed the other costs of the trial, corresponding to approximately 140 million kroner. The funds will be transferred to a research account, which is subject to the hospital's administration and public audit. Danish Physicians Vaccinations Service is a private company. The sponsor has previously received fees from Moderna for holding lectures (approximately 27,000 DKK).”
The wrapping of Moderna's interests in the University Hospitals' logos and affiliations is clearly misleading and private interests seem to play a significantly larger role than what is apparent from the invitation.
Ethical considerations regarding the scope of the experiment
To reach the target of 410,000 included Danes over 64 years of age, it is common to send invitations to between 1.3 - 4 million people. I therefore assume that all Danes over 64 years of age have been invited. In that case, it is approximately 1/4 of the entire Danish population who have or will receive an invitation with incorrect information (lack of information about the extent of the mRNA content) and of which 4 out of 5 signatories/senders have used incorrect/misleading letterhead and incorrect affiliation with the trial.
Normally, such a trial would include 6-7000 participants, as in the Enforce study.
· How can it be ethically justifiable to invite a quarter of a population into a medical trial?
· Is it reasonable to only collect passive registry data and omit a real placebo group (saline) in the trial, knowing that there are no diagnostic codes for disorders resulting from immunization with mRNA technology?
In addition, I have a number of questions for the Research Ethics Committees for the Capital Region of Denmark:
· What measures will you take to correct the information provided to the invited elderly people about:
1. The mRNA content of the influenza part of the experimental vaccine itself.
2. the real senders of the invitation to the participants who have signed up in the belief that the safety of the trial is monitored by independent Danish university hospitals?
· Will you reconsider, pause or stop the permission for the trial based on the information provided?
Regarding autopsy and increased surveillance.
Despite the scope of the DanCombo trial, no special instructions or guidelines have been issued to hospitals and doctors who are expected to perform autopsies and issue death certificates.
According to the rules for forensic autopsy, the Police must be contacted if the death is presumed to fall under Section 179 of the Health Act.
A report to the police must be made.
- when death may be a result of error, negligence or an unfortunate incident in connection with the treatment or prevention of disease.
- when it cannot be ruled out with certainty that the death is due to a criminal offence , suicide or accident, or when the death is deemed to be of police interest for other reasons.
· For the safety of the participants, shouldn't the hospitals and Danish doctors involved have received information about increased focus on examinations, treatment, post-mortem examinations and autopsy when a trial is being rolled out on such a large population group?
In addition to answers to the above questions, access to the following documents is requested in accordance with the Freedom of Information Act:
· Who, full name and position, from the Research Ethics Committees for the Capital Region of Denmark has reviewed and signed the approval of the DanCombo trial?
· Do any of these receive payment from Moderna?
· Documentation is requested in the form of meeting minutes in the Scientific Ethics Committees for the Capital Region of Denmark where the DanCombo trial was discussed.
· A copy of the approval itself with visible signatures is requested.
Kind regards
Jeanne A. Rungby, Specialist
Kim Varming's full letter
“To the scientific ethics committees in the Capital Region.
Aalborg, September 30, 2026
I would like to request a rapid assessment of the participant information for the DAN-COMBO trial:
Danish title: A pragmatic, randomized phase 4 trial to investigate the effect of an influenza/COVID-19 vaccine (mCombriax [mRNA-1083]) in people ≥65 years of age (DAN-COMBO) EU clinical trial number: 2026-526720-49-00 Participant information: Version 1.3 of September 9, 2026
My query concerns the description of mCombriax and in particular the lack of clear information that the influenza component of the vaccine is also mRNA-based.
Under "Background of the trial", the influenza vaccines that are normally used for the elderly are first described as follows:
"For people aged 70 and over, a boosted flu vaccine (e.g. a high-dose vaccine or a flu vaccine that contains an adjuvant that strengthens the body's immune response) is most often used..."
Immediately afterwards, mCombriax is described as follows:
"A combination vaccine has now been developed that consists of both a boosted influenza vaccine and a COVID-19 vaccine in a single injection."
This description does not indicate that the influenza component of mCombriax is based on mRNA technology. On the contrary, the context may give the reader the impression that the combination vaccine consists of a conventional “boosted influenza vaccine” – for example, a high-dose or adjuvanted boosted
influenza vaccine – combined with an mRNA vaccine against COVID-19.
This impression is reinforced by the description of the trial design, which explicitly states that the control group receives “a high-dose influenza vaccine and an mRNA COVID-19 vaccine,” while the combination vaccine is simply referred to as “a combination vaccine against influenza and COVID-19.”
I am aware that the product code “mRNA-1083” appears in the official title of the trial and in the heading of the side effects section. However, a product code cannot be expected to make it clear to a layperson that mRNA technology is used to produce the antigens from both influenza virus and SARS-CoV-2.
The EMA's official product information describes mCombriax as an "influenza and COVID-19 mRNA vaccine". It also states that the vaccine contains messenger RNA encoding the hemagglutinin proteins of the influenza virus as well as parts of the spike protein of the SARS-CoV-2 virus. The fact that the influenza component is mRNA-based is therefore not a matter of interpretation, but a fundamental piece of information about the composition and mode of action of the vaccine.
In my view, the vaccination platform is a key piece of information about the nature of the intervention that participants selected by lottery may receive. The question here is not whether the mRNA vaccine is safe or appropriate, but whether potential participants are given a clear and precise description of what they are consenting to.
It is apparent from Article 29(2) of EU Regulation No. 536/2014 that the information must enable the trial participant to understand the consequences of participating and must be comprehensive, concise, clear, relevant and understandable to a layperson.
I must therefore ask the committee to consider:
1. Whether the current description of mCombriax is sufficient and accurate as a basis for informed consent.
2. Whether the term 'improved influenza vaccine' in this context may give a misleading impression of the nature of the influenza component.
3. Whether the participant information should be changed to explicitly and in clear language state that mCombriax is an mRNA vaccine against both influenza and COVID-19.
4. Whether individuals who may have already given their consent based on the current information should receive corrected information and be given the opportunity to reconsider or confirm their consent.
A simple and unambiguous formulation could be, for example:
"mCombriax is an mRNA-based combination vaccine. The vaccine contains mRNA that causes the body's cells to temporarily produce selected proteins from both the influenza virus and SARS-CoV-2, so that the immune system responds to both viruses."
Since it appears from the participant information that the vaccinations will begin on October 1, 2026, I must request that this matter be treated as an urgent matter, including whether new consents should await revised participant information.
I would appreciate confirmation of receipt and request that this inquiry be forwarded to the medical ethics committee that assessed the trial.
Kind regards,
Kim VarmingSenior physician in clinical immunology
The invitation itself:
References:
6. 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)
7. 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)
8. 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/
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