Swissmedic has granted marketing authorization for Qdenga, a vaccine indicated for the prevention of dengue fever in individuals aged four years and older. The decision, announced on December 6, 2024, follows a review process that considered the assessment and approval by the European Medicines Agency (EMA). Dengue fever, a mosquito-borne viral disease prevalent in tropical and sub-tropical regions, poses a significant public health threat, potentially leading to severe complications such as dengue hemorrhagic fever or dengue shock syndrome.
Qdenga is a tetravalent vaccine containing attenuated (weakened) versions of all four dengue virus serotypes (1, 2, 3, and 4). Upon administration, these weakened viruses stimulate the body's immune system to develop defenses against the dengue virus without causing the disease itself. The vaccine is designed to protect against fever and hospitalization resulting from any of the four dengue serotypes.
The authorization by Swissmedic was conducted under Article 13 of the Therapeutic Products Act (TPA), which allows for the consideration of authorization decisions made by regulatory agencies in other countries with comparable medicinal product control. In this case, Swissmedic referenced the EMA's assessment report (EMA/862552/2022) and conducted a limited scientific review to ensure the quality, efficacy, and safety of the vaccine for the Swiss population.
Swissmedic's decision to authorize Qdenga aims to provide a readily available preventive measure against dengue fever, particularly in regions where the disease is endemic. Healthcare professionals are encouraged to consult the Swiss Public Assessment Report (SwissPAR) and related materials for comprehensive information on the vaccine's usage and safety profile. Swissmedic will continue to monitor the safety and efficacy of Qdenga in the post-marketing setting, taking necessary actions in response to any newly discovered adverse drug reactions or safety-relevant signals.
