World Hepatitis Day will be observed worldwide on 28 July 2025 with the aim of raising the public's awareness of hepatitis, a viral inflammation of the liver. According to the World Health Organization (WHO), around 254 million people worldwide had a chronic hepatitis B infection in 2022 – many of them without knowing it. A WHO estimate states that every year there are 1.2 million new infections with the hepatitis B virus (HBV), which can be transmitted by infectious blood or other body fluids. An infection can clear up in the first six months, but it can also become chronic. The hepatitis B medicines available today can reduce the viral load but cannot provide a complete cure. Chronic hepatitis B infections are one of the main causes of liver cirrhosis and liver cell carcinoma. Given the global spread, potentially severe symptoms, and limited therapeutic options of hepatitis B, the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, is placing a special focus on the disease this year. The Institute is taking part in the day of action by showing how its work contributes to protecting the population against hepatitis B.
Image / Video 1 / 4
Protection agains Hepatitis.
Source: Paul-Ehrlich-Institut
In Germany, several safe and effective vaccines against hepatitis B have been authorised that provide reliable protection against infections. The Standing Committee on Vaccination (Ständige Impfkommission, STIKO) at the Robert Koch-Institut (RKI) recommends vaccination against hepatitis B for all infants and for high-risk groups. In addition to monovalent vaccines, combination vaccines are also available that combine a hepatitis B vaccine with other vaccinations. A 6-in-1 vaccine is usually used for infants and toddlers, which in addition to hepatitis B also protects against diphtheria, tetanus, pertussis (whooping cough), poliomyelitis, and Haemophilus influenzae type b (Hib). An infection with the hepatitis D virus can only occur simultaneously with a hepatitis B infection, which means that hepatitis B vaccination also indirectly protects against hepatitis D. In its role as a federal institute, the Paul-Ehrlich-Institut monitors the quality, efficacy, and safety of these vaccines and checks each vaccine batch before it is released for the German market.
Since hepatitis B is a blood-borne infection, strict regulations apply in Germany to protect against transmission through blood and blood products. Potential donors are subject to a comprehensive list of questions before blood donation and are temporarily or permanently excluded from donation if there are risks present. The Paul-Ehrlich-Institut provides a standardised donor questionnaire for this purpose. The questionnaire is developed in cooperation with the blood donation services. Every blood donation is also compulsorily tested for HBV. The tests to be used are set out in the Haemotherapy Guideline, which is drawn up by the German Medical Association in agreement with the Paul-Ehrlich-Institut pursuant to Sections 12a and 18 of the German Transfusion Act. The Paul-Ehrlich-Institut also monitors the safety of blood and blood components along the entire transfusion chain. The aim of the haemovigilance system is to systematically record serious adverse events and reactions in donors and recipients in order to improve the safety of haemotherapy. Thanks to the measures that are in place, the risk of HBV transmission through blood products is extremely low in Germany.
Early detection is crucial for the treatment of hepatitis B. As an EU reference laboratory (EURL) designated by the European Commission for in vitro diagnostic medical devices (IVDs) in the area of hepatitis and retrovirus infections, the Paul-Ehrlich-Institut contributes to the quality assurance of diagnostic tests. The Institute carries out batch testing and performance testing of IVDs, provides reference materials, supports the coordination and harmonisation of the EU reference laboratories working methods, and advises European notified bodies and authorities. This work contributes significantly to the reliable and early detection of hepatitis infections.
In addition to its regulatory tasks, the Paul-Ehrlich-Institut also participates in scientific research on hepatitis viruses, which ensures that its staff has the technical expertise required for a reliable evaluation of complex biomedicines. For example, the Molecular Virology research group conducts research into the characterisation of the life cycles of various hepatitis viruses and hepatitis pathogenesis.
The Paul-Ehrlich-Institut's regulatory and scientific work makes an important contribution to the protection of the population in Germany against hepatitis B and supports WHO's goal of containing viral hepatitis – in particular hepatitis B – as a global health threat by 2030.
Updated: 25.07.2025
