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The influenza vaccination is a life saver – German Federal Minister of Health Jens Spahn visiting the Paul-Ehrlich-Institut

Vaccinations against influenza represent the most effective protection from an infection against this dangerous virus. The statutory German health insurance companies have now taken to bearing the costs for tetravalent influenza vaccinations for risk groups. On the occasion of the influenza vaccination season, which has just started, Jens Spahn is visiting the Paul-Ehrlich-Institut (PEI) to inform himself on site on the marketing authorisation and on batch release tests that serve to ensure the safety and efficacy of influenza vaccines.

22 / 2018

"Many patients still underestimate the risk of an influenza infection to their health and fail to receive the annual influenza vaccination. We should not take influenza lightly – it does not always end without complications. The best protection from influenza viruses is the vaccination, and so it remains. It’s good that the high-quality tetravalent vaccine is available to all patients insured", said Federal Health Minister Jens Spahn. He welcomed the decision of the Joint Federal Committee (Gemeinsamer Bundes­ausschuss, G-BA), to comply with the recommendation of the Standing Vaccination Commission (Ständige Impfkommission, STIKO). Thus, tetravalent influenza vaccines are now also available to patients that come under the statutory health insurance scheme.

Welcoming the Federal Health Minister Jens Spahn at the PEI Welcoming the Federal Health Minister Jens Spahn at the PEIWelcoming the Federal Health Minister Jens Spahn at the PEI Source: PEI

The availability of vaccines is of particular concern to the Federal Health Minister. "We have learnt from the past where delivery shortages occurred in particular regions of Germany time and again, due to discount contracts. Our experience has been considered in a draft law, which no longer allows for any exclusive contracts in the future", as Mr Spahn emphasised. In accordance with the draft Date Service and Availability Act (Terminservice- und Versorgungsgesetz, TSGV) the vaccines from all manufacturers are available to patients in future. The draft law contains requirements for an economical price determination and aims at ensuring the availability of high-quality and reasonably priced vaccines.

Professor Klaus Cichutek, president of PEI said: "We are pleased to welcome the Federal Minister of Health, Mr Jens Spahn, at the Paul-Ehrlich-Institut today to present him the broad spectrum of national and international activities in the field of medicines regulation and research." Vaccines play a central role for the health protection of the population. The experts of PEI authorize clinical trials, assess new vaccines for marketing authorisation procedures and perform the necessary batch control tests on all vaccines designed for the German market. The vaccines are then released after successful testing. In addition, the PEI experts record and assess suspected cases of vaccination complications. The PEI thus ensures the quality, safety, and efficacy of the vaccines.

Background – measures taken for the prevention of delivery shortages of vaccines

To recognise delivery shortages early and to have suitable measures in place to prevent them, the PEI introduced a list of human vaccines with delivery shortages on its website (www.pei.de/supply-shortages) as early as 2015. In July 2018, this reporting facility was further improved in co-operation with manufacturers of vaccines. Health care professional and the public frequently visit this site to obtain up-to-date information on the availability of vaccines.

In addition, PEI provides an online form for reporting regional delivery shortages (www.pei.de/lieferengpaesse-verbrauchermeldung). This form has been available since 10 October 2018. It is designed for health care professionals and consumers so that they can report if a vaccine which should be available according to the list of vaccines affected by delivery shortages is unavailable in a particular region. This helps PEI to understand the reasons for regional delivery problems thus preventing such regional delivery shortages of vaccines as best as possible as well.

Contact:
Paul-Ehrlich-Institut
Press Office
Telefon: +49 6103 77 1030
Email: presse@pei.de

The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.

Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.

The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).

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