EMA Drafts Guideline on RSV Treatments and Vaccines

Regulatory NewsRegulatory News | 31 October 2017 |  By 

The European Medicines Agency (EMA) on Tuesday released for consultation a new guideline to help companies develop new medicines, direct-acting antiviral agents, monoclonal antibodies and vaccines to treat and prevent infections caused by the respiratory syncytial virus (RSV).

According to EMA, RSV is a common respiratory virus that usually causes mild, cold-like symptoms that most recover from, though RSV can be serious, especially in infants and older adults. Currently, there is no specific vaccine and only a few treatments available for RSV, though several medicines are in development.


The draft guideline focuses on assessment of safety and efficacy of vaccines and medicines in people most likely to develop RSV lower respiratory tract infection and severe RSV disease, including newborns, infants, toddlers and older children, as well as people over 65 years who are likely to develop severe RSV disease.

Parts of the guideline also address the vaccination of pregnant women with the aim of preventing RSV disease in their babies once they are born.

Other sections discuss study design, how to assess the efficacy of a vaccine in different scenarios and the selection of the recommended dose regimen for medicines. The draft also proposes considerations on nonclinical investigations of efficacy and risk of vaccine-associated enhanced disease to support clinical trials with preventive or therapeutic products directed at RSV.

Stakeholders are invited to comment on the draft by 30 April 2018 by submitting to vwp@ema.europa.eu using the template provided in the guideline.

Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease


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