Treatment and prophylaxis of respiratory syncytial virus (RSV) infection

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Current version

Draft guideline

Consultation closed - see below
Reference numberEMA/CHMP/257022/2017
KeywordsRespiratory syncytial virus, bronchiolitis, severe RSV disease, case definition, clinical and laboratory confirmation, vaccine-associated disease enhancement, vaccination of pregnant women, monoclonal antibodies, direct acting antiviral agents, rapid diagnostic tests

The guideline covers the clinical development of vaccines and monoclonal antibodies for the prevention of RSV disease and direct acting antiviral agents (DAAs) for the treatment of RSV disease. The focus is on the assessment of safety and efficacy in populations most likely to develop RSV lower respiratory tract infection and severe RSV disease, including (newborn) infants and toddlers, older paediatric subjects predisposed to develop severe RSV disease and the elderly. The guideline also addresses vaccination of pregnant women with the aim of preventing RSV disease in their infants.

Some considerations are proposed on nonclinical investigations of efficacy and risk of vaccine-associated enhanced disease to support clinical trials with preventive or therapeutic products directed at RSV.


Document history

First version

Current version

Draft guideline



Concept paper

Published: 30/10/2017

Deadline for comments: 30/04/2018


Published: 26/10/2016

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