Paul-Ehrlich-Institut

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Pneu­mo­coc­cal Vac­cine Pneu­movax 23 im­port­ed with Chi­nese Pre­sen­ta­tion

On its website, the Paul-Ehrlich-Institut has reported on supply problems. The vaccine Pneumovax 23 is available only to a limited extent.

Additional doses of Pneumovax 23 are planned to be available as from 1 March 2021 for the German market with Chinese presentation. The product was originally manufactured for the Chinese market, but was not exported to China. With regard to the manufacturing procedure and the specification of the medicinal product, there are no differences between the product for the Chinese market and the product for the European market. The product is of equivalent quality.

The doses of the vaccines are distributed throughout Germany via wholesalers.

Details

  • The product, which is labelled in Chinese bears the tradename Pneumovax.
  • Pneumovax is identical with the product Pneumovax 23 authorised in Germany.
  • The batch number is: T033893.
  • The expiry date of this batch is 16 June 2022.
  • Note: Besides the date of last use, the external package and the label on the vial also contain the date of manufacture.
  • PZN: 17196898
  • Unlike the product for the German market, which is filled in the better-known presentation of syringes, the product for the Chinese market is filled in vials (single doses). This presentation is also authorised in Germany.
  • The product, packed in its finished presentation, does not include a German-language package leaflet. This was not possible for logistic reasons.
  • A serialisation of the product conforming to the EU regulations (i.e. labelling the package with features, which allow retracing of each individual package from the pharmacy right back to the manufacturer) could not be realised for technical reasons.
  • The German package leaflet and the German summary of product characteristics are provided by us on this page for downloading.
  • The external cartons do not contain any syringes or cannulas.
  • The documentation in the patient’s medical history and the vaccination certificate (Impfpass), as applicable, must be performed manually, since no pull-off labels in German are provided.
  • The external packet and the container of the vaccine (vial) contains the name "Pneumovax" in Latin characters.

Product in is final packaging. Source: MSD Sharp & Dohme GmbH

Vial containing the vaccine. Source: MSD Sharp & Dohme GmbH

How Should the Vaccine be Used?

Special advice given by the German Advisory Committee for Immunisation Practices (Ständige Impfkommission, STIKO) during the period of shortage should be followed.

Background

The Coronavirus-2 pandemic has led to an increased demand for pneumococcal vaccines resulting in the present supply shortages. In its role as a senior federal authority, the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, is responsible for the quality, safety, and efficacy and the official batch release testing of vaccines. In addition, it is committed to ensuring the availability of these medicines. The application of special rules laid down in the German Medicines Act, in this case, makes it possible that, if a supply shortage is identified by the Federal Ministry of Health (BMG), an exception can be made for imports if, based on Section 79 (5) AMG, a permission by the federal state (Bundesland) authorities has been pronounced. In this case English labelled products can be imported to Germany.

This website contains an overview of all current supply shortages of vaccines for human use in Germany, which is regularly updated.

Our email newsletter “Safety and availability – information on medicines safety, notes for action in the event of delivery shortages of vaccines for human use" contains information on current availabilities and delivery shortages on a regular basis.

Updated: 22.02.2021