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Vaccinations are only recommended if suitable vaccine products have been authorised. Vaccine products are only authorised if their benefit-risk ratio is favourable, i.e., the benefits clearly outweigh the risks. Infectious diseases sometimes carry serious risks, such as inflammation of the brain (measles) or paralysis (polio). These risks can be greatly reduced by vaccinations.
Vaccinations are not 100% effective. Some vaccinations have a very high efficacy, others have a slightly lower efficacy. In any case, vaccinations reduce the risk of a person becoming infected, becoming seriously ill, and infecting contact persons. Vaccinations are therefore important and protect our health as well as that of our children and those around us.
Before a vaccine product is authorised, regulatory experts examine all data collected on the quality, efficacy, and safety, and assess whether the benefit-risk ratio of the vaccine product is favourable.
Even after authorisation, the risks and side effects of all vaccine products are continuously monitored worldwide. Serious side effects after vaccination are rare, but they can occur. Therefore, the law stipulates that vaccinees or their guardians be informed about the possible risks of vaccination.
Examples of potential reactions to vaccination include fever, muscle pain, headache, nausea, drowsiness, and swelling and redness at the injection site. These vaccine reactions, which usually subside within a maximum of 10 days after vaccination, are signs of the desired immune system response to the administered vaccine. However, vaccinations are also effective when fewer or no reactions occur.
Several vaccinations against various infectious diseases are recommended for infants and toddlers; the first should occur just a few weeks after birth. This vaccination schedule is advisable because certain infections can lead to serious illnesses, especially in infants and young children, and in some cases can even be life-threatening. Administering vaccines at the recommended times protects infants and young children from infectious diseases and possible serious consequences.
Vaccines protect against infection or an infectious disease for varying lengths of time, depending on the pathogen targeted by the vaccine. The immune system remembers what it learns through vaccination and can detect and fight off invading pathogens faster than without vaccination, but protection from most vaccinations wears off over time. Therefore, in order for the immune system to react quickly enough, some vaccinations require a booster at certain intervals in order to stay effective.
Vaccination trains the immune system to successfully fight pathogens. Vaccines use pathogens to simulate an infection in the body. This process of active immunisation trains the immune system for real viral infections. Live vaccines containing live but severely weakened pathogens may, in rare cases, trigger reactions similar to the infectious disease against which they are intended to protect. People with weakened immune systems are especially vulnerable to these reactions, therefore, they should generally not be vaccinated with live vaccines.
Some infections, such as polio, have not appeared in Germany for many years thanks to consistent vaccination. Others, like diphtheria, have become rare. However, declining vaccination rates increase the risk of a higher incidence rate or even an outbreak. Infectious diseases that are rare here still appear in other parts of the world and can be brought back to Germany by travellers and through other means. If the pathogen comes into contact with many people lacking vaccination protection, the infection could immediately begin spreading again. It is therefore important that preventive vaccination against such infectious diseases continues.
Vaccine tolerability tests are part of the pre-authorisation clinical trials and the results are evaluated during the authorisation process. During federal batch testing and before batch release, the Paul-Ehrlich-Institut checks for important quality characteristics (specifications) on samples of each vaccine batch intended for the market and use, regardless of the manufacturer.
