EMA calls for feedback on new guidance to support development of medicinal products against RSV

European Medicines Agency

New guidelines to support and facilitate the development of vaccines and medicines to prevent and treat infections caused by the respiratory syncytial virus (RSV) have been released for consultation by the European Medicines Agency.

RSV is a common, seasonal virus that causes mild, cold-like symptoms. Although most people recover from the virus within a fortnight, RSV can lead to serious conditions in infants and the elderly, such as bronchiolitis and pneumonia.

There is currently no vaccination available to protect individuals against RSV disease, although many are under development, and only a few treatments are available, including several direct acting antiviral agents (DAAs). The guidance advises on the clinical development of safe and effective vaccines and monoclonal antibodies to protect against RSV and DAAs to treat RSV disease.

It focuses specifically on assessing the safety and efficacy of vaccines in medicines in at-risk groups, such as newborn babies, infants, pregnant women and people aged 65 and over.

The consultations will be open to the public for six months until 30 April 2018 and stakeholders are invited to send their comments to the EMA at vwp@ema.europa.eu.

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Citation
The Pharmaceutical Journal, EMA calls for feedback on new guidance to support development of medicinal products against RSV;Online:DOI:10.1211/PJ.2017.20203851