Joint commitment for the availability of vaccines
The third revision of the concept on delivery shortages of vaccines for human use against infectious diseases has been completed successfully. The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, has improved the procedure for reports on supply shortages for manufacturers of vaccines. This aims at being able to take action as soon as possible, thus preventing the possible effects of supply shortages on the vaccination rates. Health care providers and the general public have a high demand for up-to-date daily information on the availability of vaccines and find it at: www.pei.de/supply-shortages.
Supply shortages of vaccine products reported by the manufacturers have been published on the website of the PEI since October 2015. A delivery shortage is defined as an interruption of the delivery by the manufacturer in the usual quantity that goes beyond a period of two weeks or an unexpectedly increased demand, which cannot be met sufficiently by the manufacturer. The list of supply shortages of the PEI provides information on which vaccines are not available at the manufacturer, and for what period it will not be possible to supply them. This information is received by the PEI from those manufacturers of vaccines who have undertaken, on the basis of a voluntary obligation declaration, to report all supply shortages of vaccines to the PEI. The website of the PEI shows whether alternative vaccine products are available.
The Robert Koch Institute (RKI) continuously assesses information on supply shortages for whether they may affect the implementation of vaccination recommendations by the Ständige Impfkommission (STIKO, Standing Vaccination Commission). If this is the case, and in particular, if no alternative vaccine is available in the same composition, the STIKO at the RKI becomes involved as well. The STIKO provides instructions for action as to which options are available to use other vaccines as alternatives (www.rki.de/lieferengpaesse).
Which vaccines are available at the manufacturers is an important piece of information in order to assess a newly reported supply shortage correctly. Through repeated adaptations of the reporting system for supply shortages andwith the contribution of the Verband Forschender Arzneimittelhersteller (vfa, German Association of Research-Based Pharmaceutical Manufacturers) and the Bundesverband der Pharmazeutischen Industrie (BPI, Association of the German Pharmaceutical Industry) and in co-operation with the manufacturers of vaccines – it has become possible to optimise the reporting system to the extent that the actual supply situation of manufacturers can be better judged than before. The information service has been accepted very well since the introduction of the reporting system in October 2015. It is also available in a subscription as RSS-Feed.
"With the third revision of the concept for supply shortages, we have succeeded in improving the exchange of information between the vaccine suppliers and the federal authorities further, and in providing this information transparently," highlighted Professor Klaus Cichutek, president of the PEI.
"With this jointly undertaken project, we pursue the goal of identifying supply shortages in a timely manner, and to prevent provision shortages of vaccines."
Two internet services giving information on supply shortages of medicines
The list of supply shortages by the PEI provides information for all those who wish to inform themselves on shortages of vaccines and possible options for action. As additional information, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, Federal Institute for Drugs and Medical Devices) publishes the reported supply shortages of provision-relevant therapeutic medicines. The information provided here comprises therapeutic medicines within the responsibility of the BfArM and the PEI.
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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.).