The MMR vaccine is a safe vaccine

04 March 2015

We have reviewed the reported adverse reactions from the MMR vaccine during the past five years.

As a result of the current media coverage of the MMR vaccine, we have reviewed all reports of suspected adverse reactions from the MMR vaccine during the past five years (from 2010 to 2015). Overall, we assess that the MMR vaccine has few adverse reactions, and the adverse reactions we experience in Denmark are in accordance with the overall international experience.

During the past five years, more than 800,000 doses of the vaccine have been given to children under the Danish childhood vaccination programme. In that period, we have received a total of 173 reports of suspected adverse reactions from the vaccine.

We monitor the MMR vaccine closely and make quarterly status articles about the reported adverse reactions in our newsletter Danish Pharmacovigilance Update. Everybody can report adverse reactions on our website and all reports appear from our lists of suspected adverse reactions. Consequently, the reporting of a suspected adverse reaction does not necessarily mean that there is a relationship between the vaccine and the symptoms experienced as adverse reactions from the vaccine.

Overview of reports submitted

121 of the reports concern non-serious symptoms, such as reactions at the injection site, general malaise or fever after the vaccination.

52 of the reports are classified as serious. Serious reports are defined as a condition that results in death, is life-threatening, requires hospitalisation or the like.

See the overview of all reports submitted for the MMR vaccine during the past five years*, and the guidance for the overview.

Specific reports

The serious reports include:

  • One case of inflammation of the brain (encephalitis). The case was brought before the Patient Compensation Association, which assessed that the vaccine was probably not the cause of the disease.
  • Three cases of impaired hearing. The cases were brought before the Patient Compensation Association, which assessed that the vaccine was probably not the cause of the injuries.
  • Five cases of aluminium allergy. We assess that the vaccination is unlikely to be the cause of the allergy, because the vaccine does not contain aluminium.

Our overall conclusion is that the reported adverse reactions from the MMR vaccine in Denmark correspond to expectations and are in accordance with observations made by the European Medicines Agency (EMA) that receives reports from all EU and EEA countries.

When a large number of people are vaccinated, we will see cases of diseases or symptoms occurring at the time of the vaccination, but this does not mean that there is a link to the vaccination. To gain reliable knowledge about adverse reactions from vaccines, major scientific population studies must be made to investigate whether diseases occur more often in people who have been vaccinated compared with the population as a whole.

We still recommend the MMR vaccine, because it is an efficient vaccine protecting against measles, mumps and rubella, all of which may lead to serious complications. Measles, in particular, is a serious and extremely infectious disease. Measles is an airborne infection, and even in countries with high hospital standards like Denmark measles may cause death in one out of 2,500-3,000 people. The mortality rate is significantly higher in developing countries – between 1 and 5 deaths per 100 cases of measles.

* The report says: Earliest reaction date is 1 October 2005. This means that someone has reported an adverse reaction which occurred on that date, but it was not reported until five years later.

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