For professionals, it is very clear: When a drug or a vaccine is approved, nobody can know every possible side effect. This is no different in the current case of the serum that the companies Biontech and Pfizer have developed against the coronavirus. The Federal Institute for Drugs and Medical Devices (BfArM) states that the clinical testing of a drug is carried out on a relatively small number of participants. “Rare or very rare undesirable effects, interactions or other risks associated with drug use cannot usually be detected in clinical trials.”

The Federal Ministry of Health, however, assures in its vaccination strategy: “Only vaccines with the proof of a positive benefit-risk balance are approved and are used in the supply.” However, monitoring in the context of widespread use is necessary in order to identify potential risks of the vaccines as quickly as possible. Responsible for this in Germany is the Paul Ehrlich Institute (PEI) as the Federal Institute for Vaccines and Biomedical Medicines.

Report side effects The PEI relies on reports from manufacturers, doctors and pharmacies, but also directly from patients and their relatives. For citizens, the easiest way is via the online platform Nebenhaben.bund.de, from where the information is sent directly to the responsible authorities. At the end of the report, you will receive an electronically generated confirmation of receipt, which summarizes all the information. The processing number contained therein is used for any queries. Personal data can but do not have to be provided.

An app is also planned to facilitate such reports. According to Health Minister Jens Spahn (CDU), it should be available in app stores at the start of vaccinations. The data collected in this way should be used to “track the frequency and severity of adverse events and Sars-CoV-2 infections in vaccinated adults over a year,” according to the federal government’s vaccination strategy there will be the possibility to participate in an observational study of the institute via the app. Those who take part will be “contacted several times and asked for information on possible reactions,” said the PEI spokeswoman.

Manufacturers who have received approval for a drug or vaccine are required by the Drugs Act to pass on any information about suspected cases of side effects to the EudraVigilance database, which in turn also informs the PEI responsible in Germany.

Evaluation of suspected cases The PEI evaluates all reports of suspected vaccine side effects or complications and publishes detailed reports on them. In spring 2020 the latest balance sheet was published: “In the year 2018 3570 Suspected cases of vaccination complications reported. No new risk signal for previously unknown side effects from the vaccines used in Germany in the year 2018 identified. ” There you can read about the anonymized details of the review of 22 suspected fatal cases and 82 Cases with permanent damage after vaccination. In no case was a direct connection between vaccination and the reported course confirmed.

The reports are also forwarded by the PEI to the European Medicines Agency EMA, explained the PEI spokeswoman. This collects reports from all member states and thus forms an extensive data pool that could be used to identify possible risk signals at an early stage.

(olb)