Influenza Vaccine "Fluzone High-Dose Quadrivalent" 2020/2021 on the Market

Fluzone High-Dose Quadrivalent is a vaccine product in a U.S. presentation that is approved for persons over 65 years of age. It is marketable in Germany on the basis of the regulations of the German Medical Requirements Health Care Insurance Ordinance (Medizinischer Bedarf Versorgungssicherstellungsverordnung, MedBVSV) and is available in stores from calendar week 46 in 2020.

In the EU a comparable.vaccine is approved under the brand name "Efluelda". Efluelda is not available during the current influenza season.

Characteristics of the Goods

• The goods labelled in English carry the trade name Fluzone High-Dose Quadrivalent.

• The batches are:

  • UJ536AB
  • UJ547AA
  • UJ547AB
  • UJ547AC

• The PZN is 16820047. It is not visible on the package.
• For documentation of the vaccination in the vaccination card, the removable sticker of the ready-to-use syringe should be used.
• The serialisation of the goods for the European market - i.e. the application of features on the packaging, which allows the traceability of each individual package from the pharmacy back to the manufacturer - has not taken place.
• No German-language package leaflet is enclosed with the finished packaged goods. Therefore, we provide the German translation of the US-American package insert for download.
• The goods are delivered in packs of 10 (2 blister packs of 5 syringes) without needles.

Ready packed goods, outer carton Source: Sanofi Pasteur

Opened Packaging Source: Sanofi Pasteur

Reporting of Side Effects

Please address reports of side effects and complaints to the local representative of the pharmaceutical company: phone +49 800 54 54 010, www.sanofimedicalinformation.com.

You can also report side effects directly to the Paul-Ehrlich-Institut, Federal Institute of Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Phone: +49 6103 77 0, Fax: +49 6103 77 1234, www.pei.de or via the reporting portal www.nebenwirkungen.bund.de

You can also report at:

AMK, Arzneimittelkommission
Postfach 4 03 64 · 10062 Berlin
Heidestraße 7, 10557 Berlin
Phone: +49 30 40004 552
Fax: +49 30 40004 553
Email: amk@arzneimittelkommission.de
www.arzneimittelkommission.de

AKdÄ, Arzneimittelkommission der deutschen Ärzteschaft
Herbert-Lewin-Platz 1, 10623 Berlin
Phone: +49 30 400456-500
Fax: + 49 30 400456-555
Email: pharmakovigilanz@akdae.de
www.akdae.de/Arzneimittelsicherheit/UAW-Meldung

Use of the Vaccine

Fluzone High-Dose Quadrivalent is approved for use in adults who are 65 years of age and older. It is intended primarily for use in the prevention of outbreaks in nursing homes, retirement homes and hospitals. The vaccination recommendations published by the Standing Vaccination Committee (Ständige Impfkommission, STIKO) should be adhered to.

Background

The vaccine is marketed in Germany under Sections 2 and 3 MedBVSV. This serves to ensure the supply of the population with products of medical need of national importance during the epidemic situation as established by the German Bundestag on March 28, 2020.

The Paul-Ehrlich-Institut has previously evaluated the documents provided by the marketing authorisation holder, which contain the quality, efficacy and safety data required for a marketing authorisation according to Section 22 German Medicines Act (Arzneimittelgesetz, AMG). The documents also include the batch protocols of the batches that are marketed in Germany. The evaluation of the Paul-Ehrlich-Institut has shown that the required quality is guaranteed and that there is a positive benefit-risk ratio.

The decision to place the vaccine on the market was made by the Federal Ministry of Health (Bundesgesundheitsministerium, BMG) in accordance with the MedBVSV, among other things based on the evaluation of the Paul-Ehrlich-Institut.