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Cholera Vaccine Vaxchora with Finnish/Swedish Label Available in Germany

The cholera vaccines Dukoral and Vaxchora are expected to be unavailable until 31 March 2023 (Dukoral) and 27 March 2023 (Vaxchora) respectively. The Paul-Ehrlich-Institut has reported this shortage on the vaccine supply shortage section of its website. The marketing authorisation holder, Emergent Netherlands B.V., will supply Vaxchora with Finnish/Swedish labelling to Germany from 2 March 2023.

Details

  • The commercial name of this Finnish and Swedish labelled vaccine is also Vaxchora (see photos below).
  • The imported batch is: Vaxchora Batch 4273982, to be used by 31 May 2025.
  • The PZN is 18677329.
  • The vaccines, which are still in their original packaging, are not accompanied by a package leaflet in German.
  • A German leaflet will be provided to the patient by the pharmacy.
  • The package leaflet and the summary of product characteristics are available for download on this page.

Vaxchora Packaging Front Vaxchora Packaging Front Source: Emergent Netherlands B.V.

Vaxchora Packaging Back Vaxchora Packaging Back Source: Emergent Netherlands B.V.

Vaxchora buffer (front and back) Vaxchora buffer (front and back) Source: Emergent Netherlands B.V.

Vaxchora active ingredient (front and back) Vaxchora active ingredient (front and back) Source: Emergent Netherlands B.V.

Please note: Both components must be dissolved and mixed together before oral administration (drinking), according to the instructions in the package leaflet.

How should the vaccine be used?

The instructions listed in the package leaflet must be followed.

Background

The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, is the higher federal authority responsible for the quality, safety and efficacy of vaccines in Germany and for federal batch release of vaccines. It also advocates for the availability of these medicines.

The Ordinance to Ensure the Supply of the Population with Products for Medical Needs in the Event of the Epidemic* Caused by the SARS-CoV-2 Coronavirus (Medical Needs Supply Assurance Ordinance - MedBVSV) allows for, pursuant to section 4 (1), the placing on the German market of medicinal products that do not comply with the labelling requirements (e.g. foreign-language labelling) of the Medicinal Products Act (sections 10+11).

An up-to-date overview of current supply shortages of human vaccines in Germany (including cholera vaccines) can be found on the website of the Paul-Ehrlich-Institut.

Our email newsletter "Safety and Availability – Information on Drug Safety, Handling Information on Supply Bottlenecks of Human Vaccines" provides regular information about current availability and supply shortages.

Updated: 28.02.2023