Knowledge
- The European Commission has approved a tetravalent dengue vaccine (live vaccine, attenuated [TAK-003]) for the prevention of dengue virus (DENV) dengue fever for persons aged ≥ 4& years , regardless of previous exposure to DENV.This is the second dengue fever vaccine to be approved in the European Union, following the approval of a first dengue vaccine in 2018 for people who have previously contracted DENV.
- Clinical trials to assess long-term efficacy/safety after booster vaccinations are ongoing.
Why this matters
- The approval was based on clinical trials totaling> 28,000 children and adults, including follow-up data from 4.5 years from the pivotal Phase III study.
- The vaccine showed after 12 months had a total vaccine efficacy of 80.2 % against symptomatic dengue fever cases and prevented 90.4 % of dengue fever-related hospitalizations.
Key points
- In the last 20 years the dengue fever incidence has increased 8-fold, and the infection has become endemic in most tropical European overseas countries and territories.
- Returnees have increased local transmission in previously non-endemic areas, including France, Italy, Germany and Spain, potentially> 26 Millions of Europeans are affected.
- The vaccine is administered in 2 subcutaneous doses of 0,5 ml at the time points 0 and 3 months.
- The most commonly reported reactions included in study participants aged 4–60-_ years of injection site pain (50 %), headache (35 %), myalgia (31 %), injection site erythema (27 %), malaise (24 %), asthenia (20 %) and fever (11 %).
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Source — https://www.univadis.de/viewarticle/europaische-kommission-genehmigt-dengue-virus-impfstoff
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