Beyfortus is a medicine used to prevent lower respiratory tract infections with the respiratory syncytial virus (RSV) in newborns and infants during their first RSV season and children aged 24 months who remain susceptible to severe RSV during their second RSV season. It contains the active substance nirsevimab. In order to ensure the supply of the medicinal product during the immunisation period recommended by the Standing Committee on Vaccination (Ständige Impfkommission, STIKO), the Paul-Ehrlich-Institut has permitted the marketing authorisation holder Sanofi Winthrop Industrie to market a total of 19,000 doses of the medicinal product from France in Germany in the period from 1 March 2025 to 30 April 2025 in accordance with section 10 subsection 1a and section 11 subsection 1c of the Medicinal Products Act (Arzneimittelgesetz, AMG). These products are pharmaceutically identical to the product with German labelling and differ only in the packaging.
German product name: Beyfortus 50 mg Inj.-Lsg. i.e. Fertigspr. m. 2 K. FR
Special PZN: 19483248
Batch AZ240114, expiration date Aug
French-labelled product Beyfortus 50 mg.
Source: Sanofi Winthrop Industrie
As a result of the new RSV immunisation recommended by the STIKO in summer 2024, a high demand for Beyfortus was expected at the start of the 2024 RSV season. Several measures were taken to meet this increased demand:
The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) announced the supply shortage for medicinal products containing nirsevimab on 23 September 2024 in the Federal Gazette in accordance with section 79 subsection 5 of the AMG. The competent state authorities are authorised to grant permissions for medicinal products authorised in other countries in accordance with section 79 subsection 5 of the AMG. These permissions make it possible to import medicinal products containing nirsevimab that are not authorised in Germany and to place them on the German market. A permission to import Beyfortus from the United States was granted on 11 October 2024. The permission is considered valid until there is an announcement by the BMG that there is no longer a supply shortage.
As an additional measure, the marketing authorisation holder Sanofi Winthrop Industrie was permitted by the Paul-Ehrlich-Institut to place packs of the medicinal product from France and Spain on the market in Germany from 1 September 2024 to 31 October 2024 and packs of the medicinal product from France from 1 March 2025 to 30 April 2025 pursuant to section 10 subsection 1a and section 11 subsection 1c of the AMG.
| Country of origin | Product name | Special PZN | Batch number | Expiration date |
|---|---|---|---|---|
| France | Beyfortus 100 mg Inj.-Lsg. i.e. Fertigspr. m. 2 K. FR | 19468272 | 2070037 | Nov-2025 |
| France | Beyfortus 50 mg Inj.-Lsg. i.e. Fertigspr. m. 2 K. FR | 19483248 | 2070030 | Nov-2025 |
| France | Beyfortus 50 mg Inj.-Lsg. i.e. Fertigspr. m. 2 K. FR | 19483248 | AZ240114 | Aug-2026 |
| Spain | Beyfortus 100 mg Inj.-Lsg. i.e. Fertigspr. o. Kan. ES | 19482823 | AZ240083 | Feb-2026 |
| Spain | Beyfortus 100 mg Inj.-Lsg. i.e. Fertigspr. o. Kan. ES | 19482823 | AZ240060 | Mar-2026 |
| USA | Beyfortus 100mg Injektionslösung i.e. FER o.K. US | 19468326 | AZ240073 | May-2026 |
| USA | Beyfortus 100mg Injektionslösung i.e. FER o.K. US | 19468326 | UK297AA | May-2026 |
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 – including monoclonal antibodies.
Updated: 04.03.2025
