Favourable opinion for reimbursement for the prevention of dengue disease, in accordance with the HAS vaccination recommendations of 12 December 2024, in French territories in America (French Caribbean and French Guiana), as well as in Mayotte and Reunion Island.
Maintenance of this opinion is dependent on analysis of the results of ongoing studies, pharmacovigilance data and real-world efficacy data within a maximum period of two years.
Clinical Benefit
Substantial
The clinical benefit of QDENGA (dengue tetravalent vaccine (live, attenuated)) is substantial in the MA indication inaccordance with the current vaccination recommendations.
Clinical Added Value
minor
Considering:
clinical data having demonstrated a vaccine efficacy, from 30 days to 12 months after the second dose, on the relative reduction in symptomatic forms of virologically-confirmed dengue disease (VCD) of 80.2% (all serotypes combined),
clinical data having demonstrated a vaccine efficacy, from 30 days to 18 months after the second dose, on the prevention of hospitalisations due to VCD of 90.4% (all serotypes combined),
but taking into account:
the variability of the effects found depending on:
the viral serotype involved (DENV-1, DENV-2, DENV-3 or DENV-4) and
the serostatus (seronegative or seropositive),
the lack of data on serotype DENV-4 due to is low incidence,
the lack of demonstrated effect on severe forms of dengue,
results that suggest that the use of the vaccine is associated with an excess risk of developing a severe form of dengue (severe dengue or DHF resulting in hospitalisation) in subjects sero negative at the time of inclusion and subsequently presenting VCD caused by the DENV-3 viral serotype,
the difficulties in identifying subjects with previous dengue virus infection (seropositive) in the absence of a robust and validated diagnostic test,
the Transparency Committee deems that, on the basis of currently available data, QDENGA (dengue tetravalent vaccine (live, attenuated)) provides a minor clinical added value (CAV IV) in the care pathway, in accordance with the HAS vaccination recommendations of 12 December 2024.
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