Nirsevimab, commercial name Beyfortus, is a monoclonal antibody that is intended for prophylactic use to prevent respiratory syncytial virus (RSV) infections in infants and newborns. Nirsevimab is the first monoclonal antibody to be recommended for general prophylactic use by the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) beginning this RSV season (2024/2025).
The novel circumstances regarding the use of this medicinal product, which also affects a specific patient population, requires intensive monitoring with regard to its use and safety. For this reason, the Paul-Ehrlich-Institut is conducting an active observational study aimed at collecting extensive data on the administration and side effect profile of nirsevimab (NIS 802).
The active observational study begins in mid-November 2024 and will last until the end of September 2026.
A cumulative final analysis of the data will be carried out after completion of the active observational study. The results will then be published in a scientific journal.
Email: rsv@pei.de
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Updated: 08.01.2025
