Vaccines undergo extremely careful clinical trials. This is reasonable, as there is a low risk tolerance for vaccines, since healthy adults or healthy children are usually vaccinated. Accordingly, it is more than irresponsible, as has just happened in Russia, to approve a vaccine without sufficient clinical testing, or as is currently being practiced by the American president, to put regulatory authorities under pressure with regard to the approval process.
Once a vaccine has gone through the phases of clinical testing, it can be assumed that it is a very safe drug. However, naturally, the experience at the time of vaccine approval, even if several thousand volunteers are examined during the approval process, is limited. Rare side effects are therefore sometimes only recognizable in real use and require continuous observation of the side effects.
Like all drugs, vaccines also have unwanted drug effects. Here a distinction must be made between a (usual) vaccination reaction and vaccination complications. The temporary local and general reaction, which can arise as part of the human organism’s confrontation with the vaccine, is referred to as the usual vaccination reaction. This is characterized by redness, swelling, or pain at the injection site for a duration of 1 – 3 days (occasionally longer) and systemic reactions such as fever < 39.5° C, headache and body aches, fatigue, malaise, nausea, restlessness, swelling of the regional lymph nodes, also for a duration of 1 – 3 days.
In the case of attenuated live vaccines, the symptoms of a “vaccine disease” approx. 1 – 3 weeks after administration are also considered a usual vaccination reaction, such as a slight parotid swelling or a fleeting rash after measles, mumps, rubella or varicella vaccination or mild gastrointestinal complaints after oral rotavirus or typhus vaccination. These vaccination reactions are not reportable under the Infection Protection Act (IfSG).
In contrast, the legislator requires in the Infection Protection Act the named reporting of any “vaccination reaction exceeding the usual extent”. These vaccination complications include the occurrence of feverish seizures, anaphylactic reactions, changes in blood count or acute nerve inflammations (polyneuritis). Often you also hear the term “vaccination damage”. The Infection Protection Act understands this to be “… the health and economic consequence of a health impairment caused by the vaccination that goes beyond the usual extent of a vaccination reaction.” Modern vaccines are well tolerated, vaccination complications are only observed in rare cases. Permanent damage is a rarity, especially against the background of the approximately 45 million vaccine doses that are prescribed annually at the expense of statutory health insurance. The rate of recognized vaccination damage in 2009 was 0.046 per 100,000 inhabitants – this corresponds to an absolute number of 38 people. If you consider that in the same year alone 49 cases of subacute sclerosing panencephalitis (SSPE), a severe and always fatal complication of measles infection, were reported to the Robert Koch Institute (RKI), the benefit-risk assessment of a vaccination is relatively clear.
Overall, it can be stated that vaccinations have much lower complication rates than the diseases against which the vaccination is directed. In addition, it should also be considered that with a vaccination the individual residual risk should be weighed against the benefit of a vaccination for the entire population – this is currently also the subject of the current political and social discussion about compulsory vaccination.
Despite my absolutely positive attitude towards vaccinations, I am personally against the introduction of a general vaccination obligation. My hope is simply that the majority of the population will get vaccinated based on reliable information and care for their fellow human beings.
