Paul-Ehrlich-Institut

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PEI is taking positive stock – four years of commitment for vaccines supply

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines (PEI), in co-operation with the manufacturer of vaccines, has been committed to transparency in the availability of human vaccines since 15 October 2015. Four years after initiating the reporting system for supply shortages, the PEI is giving a favourable assessment: transparency is an important module in avoiding supply shortages by taking the appropriate action.

Up to 11 October 2019, altogether 105 supply shortages occurred for the individual vaccine products, and individual package sizes were unavailable in another 109 cases. These vaccine products are available again. Currently, supply shortages exist for seven vaccine products in all package sizes, and individual package sizes are unavailable for another three vaccines.

Syringe and Ampoule (Source: GIPPhotostock/Cultura/Getty Images)

"Shortages in the provision of individual vaccine products occur time and again. By making the market transparent, however, we can contribute to avoiding real supply shortages," says Professor Isabell Bekeredjian-Ding, head of Division Microbiology at the PEI. Professor Klaus Cichutek, president of the PEI, praised the co-operation of all parties involved by saying: “With their self-commitment to reporting supply shortages, manufacturers of vaccines have created the basis for our transparent information system on www.pei.de“.

The reporting system for supply shortages has proved its worth. The list of supply shortages of the PEI provides information showing the vaccine products that will not be delivered by the manufacturer, and how long this supply stop will probably last. The PEI receives this information from the manufacturers of the vaccines who, since January 2018, have committed themselves to reporting all supply shortages for vaccines to the PEI on a voluntary basis. The PEI website shows whether there are any alternative vaccine products. If no alternative vaccine in the same composition is available, the Standing Vaccines Committee (Ständige Impfkommission, STIKO) at the Robert Koch-Institute (RKI) will be involved. The latter gives instructions as to the action to be taken in this case. That way, paediatricians, for example, will receive useful information on which combination of vaccines they can use to react appropriately to the non-availability of a common combination vaccine for the basic immunisation of children to ensure infection protection and at the same time, keeping the number of vaccines and vaccination dates as low as possible.

In the joint project, PEI and the vaccines manufacturers with the co-operation of the Association of Researching Medicines (Verband Forschender Arzneimittelhersteller, vfa) and the Federal Association of the Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie, BPI) continuously improve the exchange of information among each other. Meanwhile, the supply shortage conception has passed through its third extension stage. The adaptations have helped optimise the reporting system to the extent that the real supply situation of the manufacturers can be judged better than before. The PEI has recently extended its range of services by the consumer report page. The reports shall contribute to identifying regional shortages at an early stage. Doctors, pharmacists, and private persons alike can make their contributions to assessing the supply situation.

Definition of Supply Shortage

A supply shortage is defined as an interruption of a delivery from the manufacturer to its usual extent or an unexpected significant increase in the demand which cannot be met adequately by the manufacturer, if such a situation is likely to last more than two weeks. Supply shortages are reported to the PEI by the manufacturer.

Updated: 15.10.2019