Vaccine supply shortages - transparent approach has proven itself in practice.

03 / 2019

Vaccine supply shortages should be avoided if possible. Since 2015, there is an established system to report such bottlenecks and to publish them at the Paul-Ehrlich-Institut (PEI). It is an effective way to achieve the goal. On 16 January 2019, all stakeholders met in the PEI to evaluate and further optimize what had been achieved so far.

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"Our supply shortages management system has reached a high level," said Professor Isabelle Bekeredjian-Ding, head of the Microbiology Department who is also responsible for the supply shortage procedure at the PEI. She presented the facts and figures from 2018 and showed that there were significantly fewer supply shortages reported to the PEI by vaccine manufacturers than in previous years. However, long-term shortages remain an issue requiring new solution strategies. All parties agreed on this point.

In addition to the vaccine manufacturers, the meeting also included the Federal Association of the Pharmaceutical Industry (Bundesverband der pharmazeutischen Industrie, BPI), the Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller, vfa), representatives from the Federal Ministry of Health (BMG) and the Robert Koch Institute (RKI) and one representative each from the Federal Association of Pharmaceutical Wholesalers (Bundesverband des pharmazeutischen Großhandels, PHAGRO) and the Federal Union of German Associations of Pharmacists (Bundesvereinigung Deutscher Apothekerverbände, ABDA).

A key topic of the meeting was the regional and local inequality in the distribution of flu vaccines in the current season. It concerned identifying causes and elaborating solutions to avoid a comparable situation in the coming years. The starting situation at the beginning of the season turned out to be comfortable. The PEI was able to release 15.7 million vaccine doses, even though – with one exception - only tetravalent influenza vaccines were offered to the German market. That was one million more doses compared with last season's consumption.

Nevertheless, regional and local distribution shortages occurred. To optimize the supply, the reporting system for suspected bottlenecks updated in 2018 proved to be very helpful. The reports from the broad and professional public were the basis for an exemption to import vaccines according to § 79 para. 5 of the German Medicines Act (Arzneimittelgesetz, AMG). This made it possible to deal with the supply bottlenecks. The supply situation normalized.

The experiences from this season will play a role for the flu season of 2019/2020. Manufacturers can provide the influenza vaccines as needed if they receive pre-orders early and in the appropriate quantities. In the future, it should be taken into account that sufficient vaccine is also available when vaccination quotas increase.

It may not be sufficiently known that with regard to flu vaccines - whosalers act as suppliers. They do not have their own stocks. This means that accurate pre-ordering is a key factor in providing adequate and consistent supply of flu vaccines.

The supply shortages for all vaccines are also being addressed by the European Medicines Agency (EMA) and the World Health Organization (WHO). Internationally, the German system is rated very positively, also because the reports are linked with instructions by the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) at the RKI on how to act appropriately.

The annual exchange among all parties involved is already in place as an established meeting. It makes it possible to further improve transparency and optimize the reporting system. In addition to that, it offers the PEI and the RKI, together with the BMG, the opportunity to quickly analyze the supply situation and take tailor-made measures.