Response to access to documents from the Danish Medicines Agency

Request for access to documents to the Danish Medicines Agency (case number 2026020389) (AI-translated)

Date: March 6, 2026. Later updates are expected.

Below are questions and answers in chronological order for the purpose of documentation for the public regarding side effects after COVID19 vaccination.

The following are reproduced unedited requests for access to documents and responses.

From: Jeanne Rungby

Sent: January 25, 2026 05:02

To: Jakob Lundsteen < JAL@dkma.dk >

Cc: Danish Medicines Agency < dkma@dkma.dk >

Subject: LMST. Handling of ADRs

Dear Jakob Lundsteen.

In continuation of our previous communication, case number 2024024182, regarding COVID19 vaccines, I have some additional questions, referring to the Freedom of Information Act on the right to access documents.

I hereby request answers to questions and access to documents regarding the Danish Medicines Agency's communication with and delivery of national data to and from the Uppsala Monitoring Center (UMC) either directly or indirectly via EudraVigilance under the European Medicines Agency (EMA).

Background.

During the rollout of the COVID-19 vaccines, adverse reactions, including deaths, associated with these products were reported to the Danish Medicines Agency by healthcare professionals and others.

The Danish Medicines Agency's website states the following:

“A company that has permission to market a medicine must submit a periodic safety update report on the safety of the product to the Danish Medicines Agency at regular intervals. … At the Danish Medicines Agency, we subsequently assess whether we agree with the conclusions of the report, and we decide whether it is necessary to implement special initiatives regarding safety. In addition, we subsequently check that the company follows up on any problems regarding the safety of the medicine…. The Danish Medicines Agency may amend, suspend or revoke the marketing authorization for a medicine if we assess that there is a need for this based on new information about the safety of the medicine.”

Source: https://laegemiddelstyrelsen.dk/da/bivirkninger/bivirkninger-ved-medicin/registrering-og-overvaagning/

The purpose of this reporting is to capture safety signals early in the so-called signal handling process, which must take place at EMA and nationally.

According to the UMC, the definition of a safety signal is “information about a new or known adverse reaction that may be caused by a drug and is typically generated from more than a single report of a suspected adverse reaction.”

Responses are requested to the following questions.

Specifications:

All questions below relate to Pfizer/BioNTech (Comirnaty), Moderna (Spikevax), AstraZeneca (Vaxzevria) and Janssen/Johnson (Jcovden), hereinafter collectively referred to as COVID19 vaccines.

Period applicable to the inquiry: December 1, 2020 – January 31, 2023.

1. Did LMST contribute data on adverse drug reactions, serious adverse drug reactions and deaths (hereinafter collectively referred to as Adverse Drug Reactions, ADRs) either directly or indirectly to the UMC? If so, at what intervals was this data reported? Who was responsible for this reporting?

2. Did LMST receive information and reports directly or indirectly from UMC regarding all ADRs during the period mentioned? This information and reports are requested to be provided.

3. If such information or reports were received, what steps were taken at the national level to advise politicians and the public? If a decision was made not to advise the government and/or the public, please provide a written copy of this decision. Who was responsible for this decision?

4. Was the Minister of Health, the Minister of Defence, the Prime Minister or other government officials informed by the LMST (or by the SST) of the number and nature of ADRs? If so, a copy of this communication is requested. Who in the LMST (or in the SST) was responsible for informing the government about the ADRs?

5. How many of the reported serious adverse reactions and deaths were investigated by the Danish Medicines Agency or other national authorities before being directly or indirectly reported to the UMC?

6. Were any exclusions made in ADRs prior to direct or indirect reporting to UMC? If so, how many were excluded and what was the justification? Who was responsible for this exclusion decision?

7. On what basis was it decided which ADRs were caused by the COVID19 vaccines and which ones should be discarded? In particular, the strategy and methods used in the investigation of reported deaths as part of the signal handling process of ADRs at the national level are requested. Examples: Autopsies, organ biopsies, microscopy (I am not requesting personally identifiable data)?

8. Are there any agreements (MOU or similar) that give the Danish Medicines Agency permission to disclose Danish data on ADRs directly or indirectly to UMC? If so, a copy of the agreement is requested. Who in LMST is responsible for submitting data to UMC?

Kind regards

DR. Jeanne Rungby, MD, Specialist

Answer: On Feb. 3, 2026 at 10:41 PM, Camilla Riesbeck < CARI@dkma.dk > wrote:

Dear Jeanne Rungby

Thank you for your inquiry of January 25, 2025 regarding the Covid-19 vaccines. You have asked a number of questions and requested access to documents.

The Danish Medicines Agency will respond to your questions as soon as possible, expected within the next week. We have included a response to your request for access to documents below.

You have requested access to information and reports that the Danish Medicines Agency has received directly or indirectly from UMC regarding reports of suspected adverse reactions to the Covid-19 vaccines during the period 1 December 2020 to 31 January 2023.

It follows from the Ministry of Justice's guidance no. 9847 of 19 December 2013 to the Freedom of Information Act , section 4.3.2, that when requesting access to documents on a "cross-cutting issue", the authority should conduct a search in the records system using the obvious search terms, and the employee who processes the access to documents request should, based on his or her knowledge of the authority's cases, immediately consider which cases and documents are covered by the request. The authority is thus not obliged to search for documents covered by the request in any other way, e.g. by manually reviewing the authority's cases.

The Danish Medicines Agency has searched our medical records system for cases involving the Uppsala Monitoring Center (WHO-UMC) regarding Covid-19 vaccines, which contain information received from WHO-UMC. We have not identified any cases or documents covered by your request based on the search.

You are welcome to contact me if you have any questions about the above.

Kind regards

Camilla Riesbeck

____________________

Camilla Riesbeck

Special consultant

Legal Advisor

T +45 21 83 99 94

cari@dkma.dk

The Danish Medicines Agency

Jura

Danish Medicines Agency

Legal Affairs

T +45 44 88 95 95

dkma@dkma.dk

Answer: On Feb. 9, 2026 at 11:37 AM, Jeanne Rungby wrote:

Dear Camilla Riesbeck

Thanks for the preliminary answer.

I look forward to responses to the other access to documents requests.

You are writing.

The Danish Medicines Agency has searched our medical records system for cases involving the Uppsala Monitoring Center (WHO-UMC) regarding Covid-19 vaccines, which contain information received from WHO-UMC. We have not identified any cases or documents covered by your request based on the search.

I understand your answer to mean that the communication must be one-way , as the Danish Medicines Agency's vigilance department only delivers data/information - via VigiBase to WHO-UMC, but that there is no communication left.

It is clear that information about aggregated, (in WHO-UMC) analyzed safety signals must go back to the national agency. Otherwise, you are just a secretariat for WHO. In that case, this information must come from other sources:

Can you please inform us where the information about safety signals for vaccines comes from when it does not come from WHO-UMC.

Or is it that the communication of safety signals for vaccines actually goes from WHO-UMC to authorities other than the Danish Medicines Agency (Indirectly)?

Does the information about safety signals come from the WHO team that makes “visits” in connection with the monitoring of WHO listed Agencies, does it come from EMA, from committees under EMA or from other sources?

I look forward to your response.

Kind regards

Dr. Jeanne A. Rungby, MD, Specialist

On Feb. 11, 2026 at 8:08 PM, Camilla Riesbeck < CARI@dkma.dk > wrote:



Dear Jeanne Rungby

I hereby return with answers to your questions in the email of January 25, 2026 and your supplementary question in the email of February 9, 2026.

The Danish Medicines Agency has included a general section below on monitoring the vaccines and then answers to your questions:

Generally

The Covid-19 vaccines (Comirnaty, Spikevax, Vaxzevria and Jcovden) were approved by marketing authorisations issued by the EU Commission on the recommendation of the European Medicines Agency (EMA), after which the marketing authorisations are valid throughout the EU/EEA.

It should be added that Vaxzevria and Jcovden have been deregistered in 2024.

The known side effects and frequencies are listed in the individual vaccine's approved summary of product characteristics and package leaflets, which are available on the EMA website.

The product information (summary of product characteristics and package leaflet) will be updated when new knowledge and documentation about side effects become available after approval.

The knowledge about adverse reactions gathered in the product summaries is based on clinical studies and adverse reaction data collected during the approval and after the use of the vaccines. Large amounts of data have been collected from clinical studies, observational studies, registry studies, periodic safety updates and reports of suspected adverse reactions to the vaccines.

The Danish Medicines Agency monitors the safety of Covid-19 vaccines in close cooperation with the EMA and the other national medicines authorities in the EU/EEA. The monitoring includes, among other things, reports of suspected adverse reactions, assessments of study results and periodic safety updates. Signals about new or changed risks of the vaccines are addressed in the European Adverse Reactions Committee, PRAC, at EMA. The Danish Medicines Agency is represented in PRAC.

The European Commission decides on changes to marketing authorisations, including changes to the summaries of product characteristics. This is done on the basis of an opinion from the EMA's Committee for Medicinal Products, CHMP, which has received a recommendation from the PRAC when it comes to the safety of vaccines. The Danish Medicines Agency is also represented on the CHMP.

Reports of suspected adverse reactions are part of the ongoing safety monitoring of the individual vaccine, as they may contain signals of new or changed risks that need to be investigated further. In a somewhat simplified description, reports are used to look for patterns or data fluctuations that may indicate previously unknown adverse reactions that need to be investigated further, or that known adverse reactions occur with a different frequency than that stated in the summary of product characteristics.

For information, it follows from Article 19(1) of Regulation No 520/2012 that a signal means information from one or more sources, including observations and experiments, which suggests a new potential causal relationship or a new aspect of a known relationship between an intervention and an event or series of related events, whether undesirable or beneficial, which is considered sufficiently likely to justify a control measure.

The Danish Medicines Agency registers reports of suspected adverse reactions in the Danish adverse reaction database and sends reports to the European adverse reaction database, EudraVigilance, at the EMA. The national medicines authorities within the EU/EEA and the pharmaceutical companies (marketing authorisation holders) must send reports of suspected adverse reactions to the European database so that reports can be included in the joint EU surveillance of vaccine safety.

A report of a suspected adverse reaction does not mean that there is an actual connection between the vaccine and the symptoms experienced. There may be other reasons, e.g. the citizen's health condition or other treatment. EMA, the Danish Medicines Agency and the other national medicines authorities in the EU/EEA continuously assess whether reports of suspected adverse reactions contain signals of new or changed risks that need to be investigated further. It may be coincidental that experienced symptoms occur in the period after vaccination, and there may be several coincidental coincidences if there is a background occurrence in the population when many have been vaccinated. Adverse reaction reports do not stand alone. They are part of an overall monitoring with data from, among other things, clinical studies, observational studies, registry studies and periodic safety updates.

The Danish Medicines Agency has continuously published information about the status of our processing of reports of suspected side effects of the Covid-19 vaccines on our theme page – Vaccines against Covid-19 (see more details under the tab “Reported suspected side effects of Covid-19 vaccines”).

Please also refer to the EMA for further information on monitoring the safety of Covid-19 vaccines: Safety of COVID-19 vaccines | European Medicines Agency (EMA)

Re 1. Did LMST contribute data on adverse drug reactions, serious adverse drug reactions and deaths (hereinafter collectively referred to as Adverse Drug Reactions, ADRs) either directly or indirectly to the UMC? If so, at what intervals was this data reported? Who was responsible for this reporting?

The Danish Medicines Agency has contributed reports of suspected adverse reactions to the WHO database, VigiBase, which is administered by the WHO's Uppsala Monitoring Center (WHO-UMC), via reports sent to the European adverse reaction database, EudraVigilance.

The Danish Medicines Agency forwards reports of suspected adverse reactions to the European adverse reaction database, EudraVigilance, at EMA. EMA forwards data to WHO's Uppsala Monitoring Centre in accordance with Article 28c of Regulation No. 726/2004, as amended by Regulation No. 1235/2010 (see possible link to consolidated version here ). You can read more about the transfer of data to WHO on EMA's website: Transfer of data on suspected adverse reactions to WHO | European Medicines Agency (EMA)

In addition, the Danish Medicines Agency has in some cases been in dialogue with WHO-UMC regarding additional information regarding specific Danish individual reports.

Regarding 2-4.

2. Did LMST receive information and reports directly or indirectly from UMC regarding all ADRs during the period mentioned? This information and reports are requested to be provided.

3. If such information or reports were received, what steps were taken at the national level to advise politicians and the public? If a decision was made not to advise the government and/or the public, please provide a written copy of this decision. Who was responsible for this decision?

4. Was the Minister of Health, the Minister of Defence, the Prime Minister or other government officials informed by the LMST (or by the SST) of the number and nature of ADRs? If so, a copy of this communication is requested. Who in the LMST (or in the SST) was responsible for informing the government about the ADRs?

WHO-UMC registers reports of suspected adverse reactions in their database, VigiBase . The Danish Medicines Agency, as a national authority participating in the WHO Programme for International Drug Monitoring, has authority access to Vigilyze, which is the search tool for searching VigiBase.

See possibly About the WHO Program for International Drug Monitoring | UMC

Reference is also made to the response of February 3, 2026 to your request for access to documents.

Re 5. How many of the reported serious adverse reactions and deaths were investigated by the Danish Medicines Agency or other national authorities before being directly or indirectly reported to the UMC?

When the Danish Medicines Agency receives a report of a suspected adverse reaction, it is registered in the Danish adverse reaction database and is then forwarded to the European adverse reaction database. Reports of suspected adverse reactions classified as serious must be forwarded to the European adverse reaction database within 15 days of receipt, cf. Article 28(1) of Regulation No. 726/2004 , which refers to Article 107a(4) of Directive No. 2001/83 .

The reports of suspected adverse reactions to the Covid-19 vaccines that have been received and registered in the Danish adverse reaction database during the period are thus forwarded to EudraVigilance. If additional information subsequently becomes available for a case, for example new information on study results, the case will be updated in the Danish adverse reaction database and a new version will be forwarded to the EudraVigilance database. A new version will then be forwarded from the EMA to the WHO-UMC.

Re 6. Were any exclusions made in ADRs prior to direct or indirect reporting to UMC? If so, how many were excluded and what was the justification? Who was responsible for this exclusion decision?

Reports of suspected adverse reactions are registered in the Danish adverse reaction database and forwarded to EudraVigilance (from which data is transferred to Vigibase).

An adverse reaction report must contain at least the following information, cf. Article 28 of Regulation No. 520/2012 :

1. An identifiable reporter

2. An identifiable patient

3. A suspected side effect

4. The affected drug(s)

Re 7. On what basis was it decided which ADRs were caused by the COVID19 vaccines and which ones should be discarded? In particular, the strategy and methods used in the investigation of reported deaths as part of the signal handling process of ADRs at the national level are requested. Examples: Autopsies, organ biopsies, microscopy (I am not requesting personally identifiable data)?

As stated above, no screening is carried out in connection with the registration and forwarding of received reports of suspected adverse reactions.

Reports of suspected adverse reactions may contain signals of new or changed risks that need to be investigated further.

In the event of reports of deaths from Covid-19 vaccines during the period you have asked about (1 December 2020 to 31 January 2023), the Danish Medicines Agency contacted the reporter/physician to obtain additional relevant information, e.g. additional information about the citizen's health conditions, examinations, course of events, information from the patient record. In this connection, we asked whether the physician had reported the case to the police with a view to a forensic autopsy and possibly an autopsy.

Please refer to further information about autopsy and postmortem on the Danish Patient Safety Agency's website - https://stps.dk/da/tilsyn/ligsyn-og-obduktion/ . Attention is also drawn to the rules set during the period regarding forensic autopsy in connection with deaths shortly after receiving vaccination against Covid-19:

1. Executive Order on Forensic Autopsy in Connection with Deaths Shortly After Receiving Vaccination Against Coronavirus Disease 2019 (Covid-19)

2. Executive Order on Forensic Autopsy in Connection with Deaths Shortly After Receiving Vaccination Against Coronavirus Disease 2019 (Covid-19)

For further information about the above, please contact the Danish Patient Safety Agency.

When the Danish Medicines Agency assesses reports of suspected adverse reactions in the form of deaths, we look at, among other things, whether there are other diseases or circumstances that could explain the death. The assessment of the causal relationship between the vaccine and the reported death is based on a number of factors, including the temporal relationship between the death and vaccination, whether there is another disease or other conditions in the vaccinated person that could explain the death.

The Danish Medicines Agency uses the WHO classification to assess causality in relation to suspected adverse events that have occurred in connection with vaccination. The WHO manual can be viewed here: Causality assessment of an adverse event following immunization (‎AEFI)‎: user manual for the revised WHO classification, 2nd ed., 2019 update

The Danish Medicines Agency will complete the assessment of a possible causal relationship when all relevant information is available, including information from patient records and any results of forensic medical examination and autopsy.

The Danish Medicines Agency has continuously published information about our handling of reports of suspected side effects of the Covid-19 vaccines on our theme page - Vaccines against Covid-19 .

Re 8. Are there any agreements (MOU or similar) that give the Danish Medicines Agency permission to disclose Danish data on ADRs directly or indirectly to UMC. If so, a copy of the agreement would be requested. Who in LMST is responsible for submitting data to UMC?

No. Please refer to the answer under Ad 1.

Question in email of February 9, 2026

We have understood your email of February 9, 2026 to mean that you are asking where information about signals from the Covid-19 vaccines comes from, including whether information from the WHO-UMC is included in monitoring the safety of the Covid-19 vaccines.

As mentioned at the outset, the Danish Medicines Agency monitors the safety of the Covid-19 vaccines in close cooperation with the EMA and the other national medicines authorities in the EU/EEA. Signals about new or changed risks of the vaccines are addressed in the European Adverse Reactions Committee, PRAC, at EMA. The Danish Medicines Agency is represented in the PRAC.

Signals about new or changed risks can come from various sources. For example, it can be based on reports of suspected adverse reactions and published studies. For more information on handling signals, please refer to: Signal management | European Medicines Agency (EMA)

National authorities participating in the WHO Programme for International Drug Monitoring have access to data in VigiBase. Article 28c(1) of Regulation 726/2004, as amended by Regulation 1235/2010 (see link under answer to question 1), states that EMA shall cooperate with WHO on matters relating to pharmacovigilance. For further information on cooperation with WHO, please refer to the EMA website: World Health Organization (WHO) | European Medicines Agency (EMA)

Kind regards

Camilla Riesbeck

____________________

Camilla Riesbeck

Special consultant

Legal Advisor

T +45 21 83 99 94

cari@dkma.dk

The Danish Medicines Agency

Jura

Danish Medicines Agency

Legal Affairs

T +45 44 88 95 95

dkma@dkma.dk

From: Jeanne Rungby

Posted: February 24, 2026 04:58

To: Camilla Riesbeck < CARI@dkma.dk >

Subject: Re: Follow-up on your inquiries of January 25, 2026 and February 9, 2026 [LMST. Handling of ADRs]

Dear Camilla

Thank you very much for your comprehensive and thorough answers, which have given rise to a few additional questions. However, I will first read your answers, including the links, to see if the remaining questions are answered there.

Can you please give me a link to our communication number and location on the Folketing's website?

Kind regards

Dr. Jeanne A. Rungby

Specialized physician, Otorhinolaryngology

Answer: The

Dear Jeanne

Thank you for your email.

The Danish Medicines Agency is processing your inquiry under case number 2026020389.

If you have any further questions, please feel free to contact me.

Kind regards

Camilla

____________________

Camilla Riesbeck

Special consultant

Legal Advisor

T +45 21 83 99 94

cari@dkma.dk

The Danish Medicines Agency

Jura

Danish Medicines Agency

Legal Affairs

T +45 44 88 95 95

dkma@dkma.dk

From: Jeanne Annette Rungby

Date: 6 March 2026 at 10:19:15 CET

Dear Camilla Riesbeck

Thank you for your reply of 11 February 2026 (case number 2026020389). It contained a great deal of useful information, which I appreciate.

However, a number of questions remain unanswered.

It is public knowledge that, as of 31 January 2023, 58,091 deaths and 7,873,104 serious adverse reactions following COVID-19 vaccinations had been recorded at the Uppsala Monitoring Centre (WHO-UMC).

These figures form the basis for questions 2–4 in my original enquiry.

It is inconceivable that the Danish Medicines Agency has not been informed of such high death tolls and that this data has not been discussed between the Danish Medicines Agency and the Ministry of Health, possibly with the Danish Health Authority acting as an intermediary.

It appears from your first reply of 3 February that

“a search in our records system for cases involving the Uppsala Monitoring Centre (WHO-UMC) concerning Covid-19 vaccines, which contain information received from the WHO-UMC. We have not identified any cases or documents covered by your request on the basis of the search.”

My question was: Whether information had been received directly or indirectly from the UMC. By ‘indirectly’ I mean via intermediaries, e.g. the EMA, the WHO or, for example, the PRAC. That question was thus only partially answered.

I therefore repeat these questions (the first one clarified):

· Did the Danish Medicines Agency receive reports or other communications regarding death tolls and serious adverse reactions (safety signals), as mentioned above, following COVID-19 vaccinations, regardless of whether the communication was from the EMA, WHO or other sources? I request a copy of these documents.

· If such information or reports were received, what measures were taken at national level to advise politicians and the public? If a decision was made not to advise the government and/or the public, please provide a written copy of this decision. Who was responsible for this decision?

· Were the Minister for Health, the Minister for Defence, the Prime Minister or other government officials informed by the LMST (or by the SST) of the number and nature of the ADRs? If so, please provide a copy of this communication. Who in the LMST (or in the SST) was responsible for informing the government about the ADRs?

Later in response no. 2 (11 February 2026) to point 1, it states “In addition, the Danish Medicines Agency has, in individual cases, been in dialogue with WHO-UMC regarding further information on specific Danish individual reports.”

· Communication regarding these individual reports is requested, unless it involves sensitive personal data

I also have further questions regarding the answers provided

Of particular interest were the two notices (Answer to point 7 of 11 February 2026) stating that a post-mortem examination could only be justified if a death had occurred within 7 days of a COVID-19 vaccination.

It should be noted that, five weeks into the vaccination campaign, there was a tightening of previous practice regarding forensic autopsies. According to the executive order of 3 February 2021 issued by the then Minister of Health, Magnus Heunicke, a post-mortem examination could only be carried out routinely if the death occurred within 7 days of vaccination against COVID-19.

In my days as a hospital doctor, it was routine that any sudden or suspicious death, including unexpected death, had to be reported to the police for the purpose of a post-mortem examination to establish the actual cause of death and investigate whether a crime had been committed. Failure to make such a report was a criminal offence.

This therefore represents a significant tightening of the rules, at a time when the first reports of deaths following COVID-19 vaccination, for example in care homes, must have been recorded.

It is stated in the Ministry of Health’s letter of 26 January 2021 (Folketingstidende Supplement E, Document 150) that

“The European Medicines Agency (EMA) has provisionally granted a conditional marketing authorisation for two newly developed vaccines against COVID-19, the BioNTech/Pfizer vaccine and the Moderna vaccine…. However, knowledge regarding the efficacy of the various vaccines, including the degree of immunity and the duration of immunity, is limited… . The long-term efficacy of the vaccines is unknown…. Several of the new vaccines are based on new technologies”

It was thus known to the Danish Medicines Agency that long-term side effects were unknown for this new technology, which had not previously been approved for use in humans. The authorisation was therefore conditional.

It was also known to the Danish Medicines Agency that no Phase 3 clinical trials had been conducted on Pfizer’s Comirnaty based on material from Process 2, as per the response from Jakob Lundsteen (case number 2024024182).

The Danish Medicines Agency was also aware that the planned ‘comparability’ studies were never completed by Pfizer. This is evident from Pfizer’s own reports to the EMA, which I have brought to the attention of the Danish Medicines Agency and the Minister for Health in previous correspondence.

With these facts in mind:

· What is the rationale for limiting the timeframe for routine post-mortem examinations to 7 days?

It must be assumed that the Danish Medicines Agency has been consulted in this matter regarding the chosen time limit.

· We request the Danish Medicines Agency’s consultation response regarding the time limit for investigations in forensic autopsies.

· How many deaths were reported in the period following the start of the vaccination campaign in December 2020 up to 3 February 2021 (the date of the announcement)?

Re: ENFORCE

· Is the Danish Medicines Agency aware of the reports and conclusions from the ENFORCE study, which aimed to assess efficacy and safety? If so, please provide a copy of the full report(s) from the entire ENFORCE study.

Re: The Danish Medicines Agency’s designation as a WLA.

· A copy is requested of the agreement, including names and signatures, between the WHO and the Danish Medicines Agency as part of the Agency’s approval as a “WHO-linked Authority” (WLA).

· Which Danish ministers (names) have approved this outsourcing of the Danish Medicines Agency’s ongoing “Performance Evaluation” to the WHO? We request all correspondence regarding this decision.

Furthermore:

You have provided a source under point 7 which is not functional. The source is https://stps.dk/da/tilsyn/ligsyn-og-obduktion/

Do you have another source?

All questions are naturally in the public interest.

Yours sincerely

Jeanne Rungby

From: Camilla Riesbeck <CARI@dkma.dk>

Subject: Follow-up from the Danish Medicines Agency (case no. 2026020389)

Date: 24 March 2026 at 16:04:58 CET

Dear Jeanne Rungby

I am writing to follow up on your email of 6 March 2026.

You state that, as of 31 January 2023, 58,091 deaths and 7,873,104 serious adverse reactions to the Covid-19 vaccines had been recorded at the Uppsala Monitoring Centre (WHO-UMC), and that this was the basis for your questions 2–4 in your original enquiry. You also state that it is inconceivable that the Danish Medicines Agency has not been informed of such high death tolls, and that this data has not been discussed between the Danish Medicines Agency and the Ministry of Health, possibly with the Danish Health Authority acting as an intermediary.

With reference to the Danish Medicines Agency’s reply of 3 February 2026, you have submitted the following three questions:

• Did the Danish Medicines Agency receive reports or other communications regarding the death toll and serious adverse reactions (safety signals) mentioned above following COVID-19 vaccinations, regardless of whether the communication was from the EMA, the WHO or other sources? A copy of these documents is requested.

• If such information or reports were received, what measures were taken at national level to advise politicians and the public? If a decision was made not to advise the government and/or the public, please provide a written copy of this decision. Who was responsible for this decision?

• Were the Minister of Health, the Minister of Defence, the Prime Minister or other government officials informed by the LMST (or by the SST) of the number and nature of the ADRs? If so, please provide a copy of this communication. Who in the LMST (or in the SST) was responsible for informing the government about the ADRs?

  
  

The Danish Medicines Agency can provide the following information in this regard:

Vigibase contains reports of suspected adverse reactions to Covid-19 vaccines, including reports forwarded from the European adverse reaction database, the EudraVigilance database. A report of a suspected adverse reaction does not necessarily imply that there is an actual causal link. Please refer to the following excerpt from VigiBase FAQ | UMC:

As mentioned in the email of 11 February 2026, reports of suspected adverse reactions form part of the ongoing safety monitoring of individual vaccines, as the reports may contain signals of new or altered risks that require further investigation. Put simply, the reports are used to look for patterns or fluctuations in data that may indicate new (unknown) adverse reactions requiring further investigation, or that known adverse reactions are occurring with a different frequency than that already stated in the summary of product characteristics. The Danish Medicines Agency has access to data from Vigibase for use in our pharmacovigilance work.

The Danish Medicines Agency monitors the safety of COVID-19 vaccines in close collaboration with the EMA and the other national medicines authorities in the EU/EEA. This monitoring includes, among other things, reports of suspected adverse reactions, assessments of study results and periodic safety updates. This monitoring is based on global data on the safety of the vaccines. Signals regarding new or changed risks associated with the vaccines are addressed by the European Committee for Pharmacovigilance (PRAC) at the EMA. The Danish Medicines Agency is represented on the PRAC.

The Danish Medicines Agency understands your first question to mean that you are requesting access to documents concerning deaths and serious adverse reactions in the form of safety signals from the WHO-UMC regarding COVID-19 vaccines, based on data in Vigibase, and received from the EMA, the WHO or other sources.

It follows from the Ministry of Justice’s guidance no. 9847 of 19 December 2013 on the Freedom of Information Act, section 4.3.2, that when a request for access to documents concerns a ‘cross-cutting issue’ (where a theme for the request has been specified), must conduct a search in the case management system using the obvious search terms, just as the employee processing the request for access, based on their knowledge of the authority’s cases, should immediately consider which cases and documents are covered by the request. The authority is thus not obliged to search for documents covered by the request in any other way, for example by manually reviewing the authority’s cases.

I am not aware that we have received any communication from WHO-UMC, either directly or indirectly, concerning signals regarding new or changed risks associated with a COVID-19 vaccine based on data in Vigibase. The Danish Medicines Agency has conducted a search in our case management system to identify cases that might contain information on safety signals from WHO-UMC regarding COVID-19 vaccines based on data in Vigibase. We have not identified any cases or documents covered by your request as a result of the search.

It should be added that signals regarding new or changed risks associated with COVID-19 vaccines are reviewed by the PRAC at the EMA, and that the EMA cooperates with the WHO-UMC on matters relating to pharmacovigilance.

The Danish Medicines Agency therefore advises you to submit a request for access to documents to the EMA to ascertain whether reports or other communications regarding safety signals from the WHO-UMC, based on data in Vigibase, have been included in the PRAC’s consideration of signals.

You can submit a request for access to documents using the form on the EMA’s website: Access to documents | European Medicines Agency (EMA)

The Danish Medicines Agency would also like to refer you to material published on the WHO’s website. Particular reference is made to material published under Reports and Newsletters. It states that: “The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from the WHO global database of individual case safety reports, VigiBase.”

Dialogue with WHO-UMC regarding further information on specific Danish individual case reports

In our reply of 11 February 2026, the Danish Medicines Agency stated that, in a few cases, we have been in dialogue with WHO-UMC regarding further information on specific Danish individual case reports. You have requested access to this correspondence, unless it involves sensitive personal data.

Adverse reaction reports contain sensitive personal health information about identifiable individuals. We have identified three cases in our records system where WHO-UMC has contacted us requesting further information from specific cases in the Danish adverse reaction database. The Danish Medicines Agency subsequently provided further information regarding the case.

It is our view that your request does not cover this material, as it specifically concerns sensitive personal data.

For your information, it can be noted that WHO-UMC has requested information on a total of 7 reports concerning suspected adverse reactions to the Covid-19 vaccines Comirnaty and Spikevax. The seven reports (one or more of the reports) concern the following symptoms: Abdominal pain, Haematochezia, Diarrhoea, Disseminated Intravascular Coagulation, Pyrexia, Headache, Ischaemic colitis, Renal failure, Changes in mental status, Multisystem Inflammatory Syndrome in Children, Shock, Oropharyngeal pain, Thrombosis, dysphonia, vomiting, atrial fibrillation, dehydration, abnormal general physical condition, nausea, rash, renal impairment, respiratory failure, chest discomfort, pyrexia, hypotension, myocarditis, dyspnoea, hypoacusis, tinnitus, derealisation, lethargy, trigeminal neuralgia.

Forensic post-mortem examination

You have also enquired about the two executive orders on forensic post-mortem examinations, to which we provided links in our reply of 11 February 2026. You state that you perceive the executive orders as a tightening of previous practice regarding forensic post-mortem examinations. You state that it follows from the executive order of 3 February 2021 that a forensic post-mortem examination could only be carried out routinely if the death occurred within 7 days of vaccination against Covid-19. You refer to the fact that, during your time as a hospital doctor, it was routine for any sudden or suspicious death, including unexpected death, to be reported to the police for the purpose of a forensic post-mortem examination to establish the actual cause of death and investigate whether a crime had been committed.

In this connection, you ask about the rationale for limiting the time period for routine medical post-mortem examinations to 7 days, and you request access to the Danish Medicines Agency’s consultation response.

It is not correct to understand that the executive order constitutes a tightening (restriction) in relation to the performance of forensic post-mortem examinations. The executive orders address the fact that the Danish Patient Safety Authority could order a forensic post-mortem examination in the event of the death of persons who died within 7 days of receiving a COVID-19 vaccine, including the day of death, provided that the Authority assessed that an autopsy was necessary to clarify whether the deaths were related to the vaccine in question. Reference is made to the news item of 29 January 2021 from the Ministry of the Interior and Health and the associated decision - Autopsy in the event of death shortly after COVID-19 vaccination | Ministry of the Interior and Health - Decision on forensic autopsy.pdf.

The executive order was thus a supplement to the general rules on forensic post-mortem examinations. As stated on the Danish Patient Safety Authority’s website, it is the police who (in accordance with the general rules of the Health Act) decide whether a forensic post-mortem examination of the deceased should be carried out. The Danish Medicines Agency refers to the Danish Patient Safety Authority for further information – a link has also been included to the Danish Patient Safety Authority’s page on forensic autopsies - Reporting deaths to the police, forensic post-mortem examination and autopsy | Danish Patient Safety Authority

The decision itself that the Danish Patient Safety Authority could arrange a forensic post-mortem examination was taken by the Minister for Health (pursuant to section 184(2) of the Health Act) on 18 January 2021 following a recommendation dated 15 January 2021 from the Danish Patient Safety Authority, the Danish Health Authority and the Danish Medicines Agency. The recommendation was submitted by the Danish Patient Safety Authority to the Ministry of Health.

For your information, it should also be noted that the provisions of Section 179 of the Health Act concerning the duty of the doctor (the doctor called in following a death) to report deaths to the police were not amended.

Reporting of deaths

You have also asked how many deaths were reported in the period following the start of the vaccination campaign in December 2020 up to 3 February 2021.

The Danish Medicines Agency has assumed that your request covers reports of suspected adverse reactions containing information on deaths relating to COVID-19 vaccines submitted to the Danish adverse reaction database. We have carried out a search of the Danish adverse reaction database to answer your question. In the period up to and including 2 February 2021, 19 reports of deaths following vaccination with Comirnaty were received.

The Danish Medicines Agency has regularly published updates on our processing of reported suspected adverse reactions. Please refer to our dedicated page - Reported suspected adverse reactions to COVID-19 vaccines.

This shows that, as of 20 October 2025, the Danish Medicines Agency has received and assessed 170 reports concerning deaths in the period following vaccination with Comirnaty. In 166 cases, it has been assessed that it is less likely that the deaths were related to the vaccine, and that it is highly likely that the deaths were due to other causes. In four cases, it is not possible to assess whether the death was caused by the vaccine or by underlying medical conditions.

ENFORCE

You have asked whether the Danish Medicines Agency is aware of the reports and conclusions from the ENFORCE study, which aimed to assess efficacy and safety. You would like a copy of the full report(s) from the entire ENFORCE study.

The Danish Medicines Agency refers you to Rigshospitalet’s website, where reports and publications from the ENFORCE study have been published: ENFORCE

WLA

You have requested a copy of the agreement, including names and signatures, between the WHO and the Danish Medicines Agency as part of the Danish Medicines Agency’s approval as a “WHO Listed Authority”. You have also requested information on which Danish minister approved this outsourcing of the Danish Medicines Agency’s ongoing “Performance Evaluation” to the WHO.

The Danish Medicines Agency, together with the other medicines authorities in the EU, has been included on the WHO’s list following a joint evaluation process. It is the WHO that decides whether an authority can be included on the list:

“A WHO Listed Authority (WLA) is a regulatory authority or a regional regulatory system which has been documented to comply with all the relevant indicators and requirements specified by WHO for the requested scope of listing based on an established benchmarking (GBT) and a performance evaluation process”, cf. List of WHO Listed Authorities (WLAs).

There is no signed agreement to which we can grant you access.

Inclusion on the list of WLAs does not entail any outsourcing to the WHO.

For your information, I have included a link to the EMA’s news item on inclusion, and news from the Heads of Medicines Agencies:

• European medicines network designated as WHO listed authority | European Medicines Agency (EMA)

• From Heads of Medicines Agencies: Recently Published:

  
  

We hope that our response above and our reply of 11 February 2026 have given you a better understanding of how cooperation and communication between the Danish Medicines Agency and other authorities (global and national) takes place.

Finally, we would like to note that when you wish to know “who within the Danish Medicines Agency” has been responsible for communicating and making decisions regarding communication, this is not a matter for any single individual within the Danish Medicines Agency. It is something that takes place through cross-functional collaboration between relevant specialist units and the management of the Danish Medicines Agency, and it is therefore also the Danish Medicines Agency as an organisation that can be considered responsible for our overall communication to politicians, healthcare professionals and the general public.

Kind regards

Camilla Riesbeck

____________________

Camilla Riesbeck

Specialist Consultant

Legal Adviser

T +45 21 83 99 94

cari@dkma.dk

Danish Medicines Agency

Legal Affairs

Danish Medicines Agency

Legal Affairs

T +45 44 88 95 95

dkma@dkma.dk