Suspension for injection for active immunisation (vaccination) against diseases caused by smallpox, mpox and vaccinia viruses in adults

Information on authorisation

The medicinal product JYNNEOS is a “live vaccine” produced from the Modified Vaccinia Ankara-Bavarian Nordic® strain. The viruses in this vaccine are attenuated (weakened pathogens) and non-replicating.

JYNNEOS was originally developed and authorised as a vaccine against smallpox. Its authorisation in the prevention of the zoonotic viral disease mpox is secondary to this. Mpox, previously known as monkeypox, is found mainly in tropical rainforest areas of central and western Africa, and is occasionally transmitted to other regions.

JYNNEOS is recommended primarily for the prevention of mpox in persons who, for personal or work reasons, are at a high risk of infection.

In deciding whether to authorise JYNNEOS, Swissmedic took into account parts of the assessments of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) as well as the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of these foreign authorities, the preconditions for a full SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Public Summary SwissPAR are not met. Swissmedic refers to the authorisation by the foreign reference authorities (EMA/655793/2022, EMA/369203/2013, FDA STN 125678/0).

Further information on the medicinal product

Information for healthcare professionals:

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 Public Summary SwissPAR.}

^{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.}