RegulatoryOfficial

Germany allows French and Swedish/Finnish Vimkunya packs amid chikungunya vaccine shortage

🇩🇪 Paul-Ehrlich-Institut · Wed 28 Oct 2026

The Paul-Ehrlich-Institut has permitted foreign-language packs of Bavarian Nordic's chikungunya vaccine from 19 October to 15 November 2026, after the company reported a supply shortage.

The Paul-Ehrlich-Institut (PEI) has authorised Bavarian Nordic A/S to place Vimkunya packs labelled in French and in Swedish/Finnish on the German market. The permission runs from 19 October to 15 November 2026 and is intended to meet expected demand during a supply gap.

The marketing authorisation holder reported a shortage of the vaccine from 24 September, expected to last until about 15 November 2026. Vimkunya is a travel vaccine that protects adults and adolescents aged 12 and over against disease caused by the chikungunya virus. The PEI granted the exemption under sections 10(1a) and 11(1c) of the German Medicinal Products Act (AMG), which cover labelling and package leaflet requirements.

According to the PEI, the foreign-language products are pharmaceutically identical to the German-labelled product and differ only in their packaging materials. They still carry the trade name Vimkunya. The syringe label, the package leaflet and the carton are in French or Swedish/Finnish respectively. Each pack is supplied with a German-language leaflet, which is attached by a band to the French packaging. The German leaflet and the summary of product characteristics can be downloaded from the PEI page.

The presentation is a prefilled syringe without a needle. The Swedish/Finnish pack has the central pharmaceutical number (PZN) 21105358, batch FDP00805 and an expiry date of 31 August 2028. The French pack has PZN 21105370, batch FDP00790 and an expiry of 31 January 2029. The PEI says users should follow the instructions in the package leaflet.

What it means for your team

  • Supply and distribution teams should note the two PZNs and batch numbers, and the limited 19 October to 15 November 2026 window for the foreign-language packs.
  • Labelling and quality teams should be aware that the exemption relates to packaging only; the PEI describes the product as pharmaceutically identical to the German-labelled version.
  • Pharmacies and clinics need to make sure the German leaflet supplied with the French pack stays with it, and that staff know where to find the German leaflet and summary of product characteristics.

Official source: Paul-Ehrlich-Institut ↗

Article written by VigiEye from the official source (Paul-Ehrlich-Institut). AI-assisted; check the source before acting.

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