The Danish childhood immunisation programme is offered free of charge to all children and includes vaccination against nine infectious diseases. In addition, girls are offered vaccination against cervical cancer.
- The Danish Health Authority recommends the diseases children should be vaccinated against to the Danish Minister for Health.
- The Danish Minister for Health determines which vaccinations should be offered free of charge under the programme and to whom.
- Statens Serum Institut is responsible for the supply of vaccines in Denmark and for monitoring the coverage and adherence to the childhood immunisation programme.
- The Danish Medicines Agency and the European Medicines Agency (EMA) authorise the vaccines and monitor the safety of the vaccines after they are marketed.
Vaccines in the Danish childhood immunisation programme
The Danish childhood immunisation programme includes vaccination against the following diseases: Diphtheria, tetanus, pertussis, polio (infantile paralysis), meningitis and epiglottitis caused by Haemophilus influenzae type b (Hib), meningitis and other serious diseases caused by pneumococci, measles, mumps, rubella and cervical cancer (girls).
The Danish Medicines Agency’s monitoring of the safety of the vaccines
Possible adverse reactions from the vaccines in the childhood immunisation programme are monitored closely. We monitor the safety of the vaccines in close collaboration with the EMA and the drug regulatory authorities in the other EU countries.
Both healthcare professionals and citizens can report suspected adverse reactions directly to the Danish Medicines Agency. A suspicion is enough to submit a report. You can send a report if you suspect that the symptoms may be caused by a vaccine – you do not have to be sure that there is a relationship. We register all reports of suspected adverse reactions in a database of adverse reactions. In connection with the registration, we assess whether additional information is required – it may be from the person submitting the report or the patient’s treating doctor. We also assess whether the adverse reactions are serious.
In accordance with international criteria, the Danish Medicines Agency defines an adverse reaction report as serious if the condition requires hospitalisation or prolongation of hospitalisation, results in persistent or significant disability or incapacity (or inability to attend school), birth defects, congenital anomaly, is life-threatening or results in death.
The reporting of a suspected adverse reaction does not necessarily mean that there is a documented causal relationship between the medicinal product used and the reported adverse reaction. When we assess reports of suspected adverse reactions, one of the things we look at is whether there is a greater likelihood that other diseases or circumstances can explain the symptoms.
The Danish Medicines Agency has a vaccination panel consisting of internal and external experts. Assessments of all Danish reports of suspected adverse reactions from vaccines in the Danish childhood immunisation programme, including the HPV vaccines, are made quarterly. The vaccination panel meets biannually and ad hoc if needed.
The Danish Medicines agency sends reports of suspected adverse reactions concerning vaccines to the European database of adverse reactions (the EudraVigilance database) at the European Medicines Agency (EMA). Information about the patients/citizens name, civil registration number or contact information is not sent to the European database. The pharmaceutical company that produces the medicine, the EMA, the national competent authorities in the EU/EEA countries, and the European Commission have access to the data in the EudraVigilance database for drug safety monitoring purposes.
The adverse reaction reports are included in the Periodic Safety Update Reports (PSUR) that the companies must prepare as a part of their routine monitoring. All PSURs are analysed by the EMA’s scientific committee to assess whether the risk/benefit balance of the vaccines has changed.
The EMA sends information from the Eudravigilance database to the WHO. The WHO runs a pharmacovigilance programme and maintains a global register of reports of adverse reactions from medicinal products.
Known adverse reactions
The known adverse reactions from the vaccines are described in the product information of the individual vaccines.
The summary of product characteristics describes the adverse reactions identified in clinical trials conducted before the vaccines were authorised as well as adverse reactions discovered after the vaccines were marketed. As we gain more experience with the vaccines worldwide, the adverse reactions described in the product information of the vaccines may be updated.
Consequently, you should keep updated about any changes to the product information.
You can report side effects in humans from medicines and vaccines on our website.
Free access to interactive overviews of all reported adverse reactions from medicines and vaccines in Denmark
On the Danish Medicines Agency’s website you can search for all reported suspected adverse reactions in the interactive Adverse Drug Reaction overview made available by the Danish Medicines Agency.
In the interactive Adverse Drug Reaction overview, you can select search filters, e.g. age, year, gender and seriousness. Moreover, you can search for reports submitted by either healthcare professionals or patients and relatives.
If you want to search for reported suspected adverse reactions related to the vaccines in the childhood immunisation programme, search for the individual vaccine components; e.g. search for human papilloma virus to find information about the HPV vaccine, and for information about the MMR vaccine protecting against three childhood diseases, search for each individual disease, e.g. rubella virus.