Nirsevimab is an investigational monoclonal antibody (mAb) being developed by Merck Sharp & Dohme Corp. and Pfizer, Inc. as a potential treatment for COVID-19. The antibody targets the Spike protein of the SARS-CoV-2 virus, which helps the virus attach and invade host cells. Nirsevimab is being studied in a Phase 1/2 clinical trial to evaluate its safety and efficacy in treating mild to moderate cases of COVID-19 in adults. The trial is expected to be completed in late 2021.
Nirsevimab, sold under the brand name Beyfortus, is a human-made protein belonging to a class of medications called monoclonal antibodies. Here's a breakdown of its key characteristics:
- Function: Designed to prevent lower respiratory tract infections caused by the Respiratory Syncytial Virus (RSV) in infants and young children.
- Mechanism: Nirsevimab binds to a specific protein (F protein) on the surface of the RSV virus, preventing it from entering and infecting the cells in the respiratory tract.
- Target age group:
- Approved by the US FDA in July 2023 for:
- Infants born during or entering their first RSV season
- Children up to 24 months old who are vulnerable to severe RSV disease in their second season
- In the European Union: indicated for the prevention of RSV in neonates and infants during their first RSV season.
- Approved by the US FDA in July 2023 for:
Key points to remember:
- Nirsevimab is administered as a single dose injection.
- It provides passive immunity, meaning it offers temporary protection without stimulating the body's own immune response like a traditional vaccine.
- Studies show Nirsevimab can reduce the risk of severe RSV disease by about 80% and offers protection for at least 5 months, covering the typical RSV season.
- Nirsevimab is not a substitute for routine childhood vaccinations.
- It's crucial to consult a healthcare professional to determine if Nirsevimab is suitable for a specific child, considering their individual health status and risk factors.
Anatomical Therapeutic Chemical Classification
J - Antiinfectives for systemic use
J06 Immune sera and immunoglobulins
J06B - Immunoglobulins
J06BD Antiviral monoclonal antibodies
ATC Code
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Nirsevimab