Allowing labeling in different languages for implementing RSV protection
A medication recommended for infants to combat respiratory infections brought on by the RSV virus is sanctioned for use in Germany, even if its packaging is marked solely in French or Spanish. According to the Paul-Ehrlich-Institute (PEI), the federal organization responsible for vaccines and biomedical drugs, these medications are pharmaceutically identical.
The Standing Vaccination Commission (Stiko) only endorsed the antibody drug for defense against the Respiratory Syncytial Virus (RSV) for newborns and infants in June. The PEI expects a surge of interest for the antibody Nirsevimab at the onset of the infection period in the fall. To address this surge, the manufacturer Sanofi Winthrop Industrie will import packaging of the drug from France and Spain into the German market in September and October.
Consequently, the labels on the syringe, the information leaflet, and the box will be in French or Spanish. A German-language version of the information leaflet is available for download on the PEI website, the institution shared.
Infants under one year old are most often hospitalized due to severe respiratory infections caused by RSV. Consequently, Stiko advises early protection for all newborns and infants. The drug should be administered during the first RSV season following birth, which generally spans from October to March.
Protection against RSV is expected to become accessible through health insurance companies soon. The antibody Nirsevimab is set to be included in the service catalog of statutory health insurance funds at the start of the RSV season.
Despite the medication's packaging being primarily in French or Spanish, German authorities still approve its use for combating RSV infections in infants. Parents who require a German version of the medication's information leaflet can download it from the Paul-Ehrlich-Institute's website.
