Pneumococcal Vaccine Pneumovax 23 Imported from Japan

On 12 March 2020, The Paul-Ehrlich-Institut published some information on the availability of pneumococcal vaccines on its website. A shortage for Pneumovax 23 is claimed, while Prevenar 13 is available only to a limited extent.

Probably from 3 April 2020, Pneumovax 23 vaccine imported from Japan labelled in Japanese is available on the German market. Importing this vaccine is possible based on an exceptional authorisation pursuant to the German Medicines Act (AMG). The vaccine will be distributed by wholesalers throughout Germany.

Details

• The product, which is labelled in Japanese, is marketed in the country of origin as "Pneumovax NP". Pneumovax NP is identical to Pneumovax 23 authorised in Germany.

• The two batches imported are:

  • Pneumovax NP, Batch No.: R033352, expiry date: 11 June 2020
  • Pneumovax NP, Batch No.: R033353, expiry date: 13 June 2020
• The assigned PZN is 16653218
• A package leaflet in German is missing in the finished packed product. This was not possible from the logistic point of view. A serialisation of the product (i.e. providing features on the packaging which permit traceability 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 summary of product characteristics are provided as a download on this page
• In contrast to the syringe presentation well known in Germany, these imported lots are marketed in vials (single doses). This dosage form is also authorised in Germany.
• The Japanese tradename "PNEUMOVAX® NP" printed in Latin letters is only on the secondary packaging (outer carton) but not the primary container (vial).

Finished packed product Source: MSD Sharp & Dome GmbH

Vial Source: MSD Sharp & Dome GmbH

How should the vaccines 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, which has caused supply shortages for these products. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, is the competent senior federal authority responsible for the quality, safety, and efficacy, as well as the official batch release of vaccines in Germany. In case the Federal Ministry of Health (BMG) publishes a supply shortage, the use of special regulations laid down in the German Medicines Act (AMG) permits the import of medicines under special conditions [AMG, Section 79 (5)]. These rules are applied in this case to import products available from third countries, in this case, Japan, at short notice.

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

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