The High Council for Public Health does not recommend the use of the vaccine against dengue fever before a marketing authorization, being studied in Europe.
The HCSP has decided. The High Council for Public Health is not in favor of the early use of the vaccine against dengue in the French territories of America (Guyana, Martinique, Guadeloupe, etc.). The opinion, dated October 7, has just been published on the Haut Conseil website and converges with a previous opinion issued in June, unfavorable to the use of the vaccine in Réunion and Mayotte.
Members of the HCSP have been seized as the dengue virus has spread endemically in TFAs facing a dengue epidemic. Dengvaxia, the vaccine against dengue fever, is already registered in some countries (Mexico, Brazil, El Salvador) and used in the Philippines. But at European level, it does not yet have a marketing authorization (AMM). Indeed, the vaccine is currently being evaluated at the European Medicines Agency (EMA).
Insufficient data
“The High Council of Public Health is not in favor of the anticipated use of this vaccine in TFA, can we read in the report. Certain co-morbidities, mainly sickle cell anemia, could favor the onset of severe forms of dengue, but the data are insufficient to recommend the implementation of a targeted vaccination on these populations by a derogatory procedure allowing early access before marketing authorization ”.
In addition, the fact of providing access to a vaccine which does not have an MA is part of a procedure that must “respond mainly to emergency situations or therapeutic deadlock which do not correspond to the current situation”, according to the HCSP.
“This would require determining the age groups to be vaccinated, with a theoretical risk of subsequently being unauthorized. The reciprocal effects between dengue vaccination and the currently epidemic Zika represent an unknown that should be better understood ”.
Clinical trial needed
Consequently, the HCSP recommends the “establishment in TFAs of a clinical trial of dengue vaccination in people with major sickle cell syndrome”, which increases the risk of serious infections. “This trial will make it possible to vaccinate people according to their seropositivity, and to identify possible adverse effects specific to sickle cell disease”.
Finally, the High Council recommends strengthening individual and collective protective measures against mosquitoes. And all the more so “given the rhythmicity of the epidemic cycles, it is likely that an epidemic will occur in the near future, without it being possible to predict the date, the extent and the severity, in particular because of the possible interference with the Zika virus which is currently circulating actively in this area ”.
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