Dispersion for injection in a pre-filled syringe for the prevention of lower respiratory tract disease in adults caused by respiratory syncytial virus (RSV).Injektionsdispersion in einer Fertigspritze zur Vorbeugung von Erkrankungen der unteren Atemwege bei Erwachsenen, die auf das Respiratorische Synzytial-Virus (RSV) zurückzuführen sind.

About the medicinal product

mRESVIA is a vaccine that helps prevent respiratory tract disease caused by respiratory syncytial virus (RSV).

mRESVIA contains a special messenger RNA (mRNA) that stimulates the body to recognise a specific protein of the RSV and form antibodies against it, thereby enabling the immune system to attack the virus during subsequent contact and protect the individual from lower respiratory tract illnesses.

RSV is a common, highly infectious virus that can cause respiratory tract disease in people of all ages. Elderly adults are at higher risk of serious complications.

mRESVIA was first approved by Swissmedic on 17 April 2025 for active immunisation for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

The present indication extension means that mRESVIA can also be used for active immunisation for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults between 18 and 59 years of age who present an elevated risk of LRTD caused by RSV.

The present indication extension for mRESVIA was authorised under Article 13 of the Therapeutic Products Act (TPA). This authorisation procedure is applied in certain circumstances when a medicinal product is already authorised in another country with comparable medicinal product control.

In such cases, Swissmedic may take account of the results of the assessments conducted by that country’s medicinal products regulatory authority. These involve checks on the quality, efficacy, and safety of the medicinal product, and the extent to which the results can be accepted for Switzerland. The consideration of the results of foreign authorisation procedures is intended to help ensure that medicines that are already authorised abroad can be made available to patients in Switzerland as quickly as possible.

In deciding whether to authorise this indication extension for mRESVIA in Switzerland, Swissmedic accepted the assessment and approval decision of the European Medicines Agency (EMA). Swissmedic has not, therefore, conducted its own scientific review.

Accordingly, in the SwissPAR (Swiss Public Assessment Report) and the resulting Summary report on authorisation, Swissmedic refers to the Assessment Report and summary report issued by the reference authority.

www.ema.europa.eu

Further information on the medicinal product

Information for healthcare professionals: 

Information for patients (package leaflet):

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}