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Cholera Vaccine "Vaxchora" Available in Germany with Spanish Label

The cholera vaccine Dukoral is not expected to be available until 30 January 2023. The Paul-Ehrlich-Institut has reported on this shortage on the vaccine supply shortage section of its website. "Vaxchora" is a cholera vaccine that has also been authorised in Germany. It can be used as an alternative to Dukoral for the prevention of cholera. The marketing authorisation holder Emergent Netherlands B.V. is expected to deliver Vaxchora with Spanish labelling to Germany by the end of August 2022.

Details

  • The commercial name of this Spanish labelled vaccine is also "Vaxchora" (see photos below)

  • Imported batch information:

    • Vaxchora, batch: 4260585, usable until the end of September 2023
  • The PZN is 18302339
  • The vaccine, originally packaged in Spain, is 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 front of package Vaxchora front of package Source: Emergent Netherlands B.V.

Vaxchora back of package Vaxchora back of package 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.

Section 4 (1) of 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 medicinal products that do not comply with the labelling requirements (e.g. foreign language labelling) of the Medicinal Products Act (sections 10+11) to be placed on the German market.

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 medicines safety, instruction notes on human vaccine supply shortages" provides information about current availability and supply shortages regularly.

Updated: 30.08.2022