How to develop vaccines and medicines that prevent and treat respiratory syncytial virus (RSV) infection
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New guideline to facilitate development of vaccines and treatments out for consultation until April 2018
The European Medicines Agency (EMA) has released a new Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - First version for a six-month public consultation.
Stakeholders are invited to send their comments by 30 April 2018 to vwp@ema.europa.eu using the template provided in the guideline.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover within one to two weeks, but RSV can be serious, especially in infants and older adults. It is the most common cause of lower respiratory tract infections, such as bronchiolitis (inflammation of the small airways in the lungs) and pneumonia (infection of the lungs), in newborn babies and young infants. RSV is also a significant cause of respiratory illness in the elderly.
Several medicines are currently under development for RSV disease, for which there is no specific vaccine and only a few treatments available.
EMA's new draft guideline provides advice for medicine developers on how they can best develop safe and effective vaccines and monoclonal antibodies to prevent RSV disease, and direct-acting antiviral agents (DAAs) to treat it.
The 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 newborn babies (0 to 27 days), infants (28 days to 11 months), toddlers (12 to 23 months), older children who are likely to develop severe RSV disease and people aged over 65 years.
It also addresses the vaccination of pregnant women with the aim of preventing RSV disease in their babies, once they are born.
Other areas for which guidance is provided include diverse aspects such as study design, how to assess the efficacy of a vaccine in different scenarios, and the selection of the recommended dose regimen for medicines.