Blood Safety Increased Further
In Germany, blood and blood products are safe medicinal products. Experts from the Paul-Ehrlich-Institut make sure that that continues to be the case, in spite of known and emerging pathogens.
Blood is an essential raw material for the manufacture of medicinal products. A careful selection of donors by means of standardised questionnaires, physical examinations and the testing of donations for selected pathogens prevent the transmission of pathogens via blood components.
A prerequisite for a high level of safety is the continual monitoring and assessment of potential new risks to blood safety, so that the necessary measures can be taken in good time.
Prof. Markus Funk , Head of the Pharmacovigilance II (Blood Safety) Unit
In 2019/20, three viruses required special attention: the West Nile virus (WNV), the hepatitis E virus (HEV) and the SARS-CoV-2 coronavirus.
In 2019, the first people in Germany became infected with WNV. It was therefore no longer enough to defer donations of blood from people returning from risk areas. In addition, the number of HEV infections was rising continuously. The challenge: with donors who are infected with HEV but do not have any symptoms, there is the risk of transmission via blood components.
In both cases, the Pharmacovigilance II (Blood Safety) unit initiated graduated plan procedures, which led to risk-minimising measures:
- West Nile virus: testing or deferral of blood donations from people returning from risk areas has been mandatory since June 2020.
- Hepatitis E: the testing of blood components for transfusion and stem cell preparations has been mandatory since January 2020; with effect from 2021 this is also the case for frozen fresh plasma.
In early 2020, the SARS-CoV-2 coronavirus burst upon the world stage. The question immediately arose as to whether the virus could be transmitted via blood products. The Pharmacovigilance I and II units responded immediately with a study carried out in conjunction with three virological institutes. The evaluation of the laboratory data showed that the SARS-CoV-2 genome could not be found in blood samples from people with few or no symptoms. This was only the case with people who were seriously ill. In any case, donors with symptoms of disease are deferred from giving blood in Germany. No risk of transmission of SARS-CoV-2 via blood could therefore be identified. Blood donations are especially important in times of pandemic, in order to guarantee the supply of these often life-saving blood components.
Funding
Federal Ministry of Health (BMG) – SARS-CoV-2
Literature
Corman VM, Rabenau HF, Adams O, Oberle D, Funk MB, Keller-Stanislawski B, Timm J, Drosten C, Ciesek S (2020): SARS-CoV-2 asymptomatic and symptomatic patients and risk for transfusion transmission.
Transfusion 60: 1119-1122.
Funk MB, Heiden M, Müller S, et al. (2020): Hämovigilanz-Bericht des Paul-Ehrlich-Instituts 2018: Auswertung der Meldungen von Reaktionen und Zwischenfällen nach § 63i AMG.