The COVID-19 vaccination campaign in Germany, which began on 27 December, 2020, was designed in such a way that the majority of vaccinations were initially carried out in the newly established vaccination centres. Vaccinations in senior care and nursing homes (by mobile vaccination teams), hospitals, private companies, public health offices, and pharmacies followed. All vaccinations administered were reported electronically to the Robert Koch-Institut's (RKI) Digital Vaccine Monitoring system (Digitales Impfquotenmonitoring, DIM), whereby any personal data was pseudonymised via an algorithm specially developed by the Federal Printing Office (Bundesdruckerei). Registered doctors began administering COVID-19 vaccinations in April 2021. Case numbers were reported in a timely manner by the vaccinating practices to the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) and on a staggered basis to the Association of Statutory Health Insurance Physicians (ASHIP, German: Kassenärztliche Vereinigung, KV) responsible for the federal state where the practice was located. Case numbers were not forwarded to health insurance providers as done for other vaccinations. The ASHIP data is currently being pseudonymised by the Bundesdruckerei (using the same algorithm as the DIM) as part of the RKI's vaccine surveillance and can be used in combination with the DIM data by the RKI and the Paul-Ehrlich-Institut. Since April 2023, the administration of COVID-19 vaccinations is considered standard medical care and is billed via the statutory health insurance providers, see the Association of Statutory Health Insurance Physicians Westfalen-Lippe (2024) as an example.
All steps in the data processing chain related to the recording and reporting of vaccinations in the first few years of the pandemic had to be redesigned and implemented for the vaccination campaign. These steps included the entire data flow from the various reporting bodies, pseudonymisation via the Bundesdruckerei, and the provision of the data to the RKI and the Paul-Ehrlich-Institut. The algorithm used by the Bundesdruckerei for pseudonymisation was also newly developed.
These extensive new developments and the structured distribution of the various data required for pharmacovigilance at the population level have made monitoring of the new COVID-19 vaccines very difficult in Germany in comparison to other countries. This is due to the fact that, in addition to the vaccination data itself, data must be available for mapping vaccine-related outcomes (especially adverse events). Mapping this kind of data in the German system is most likely to be achieved by using the routine data of the almost 100 statutory and about 40 private health insurance providers, in which relevant hospital stays, emergency care, etc., are included. Another challenge is the lack of a unique identifier for all residents, such as the social security number used in Europe's Nordic countries. The lifelong individual health insurance number acts as a unique identifier in Germany for approximately 90 percent of health insurance policyholders that have statutory health insurance.
