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Regulatory approvals boost dengue prophylaxis

Two important developments have emerged in October regarding the first dengue vaccine, Dengvaxia (CYD-TDV), a live attenuated tetravalent vaccine developed by Sanofi Pasteur and first registered in Mexico in December 2015. On 18 October 2018, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) announced that it recommended granting a marketing authorisation for Dengvaxia, and shortly thereafter on 30 October 2018 the US Food and Drug Administration (FDA) granted priority review for this vaccine candidate.

Firstly, the CHMP’s decision carries significant implications for patient access to Dengvaxia. Dengvaxia is intended for prophylaxis against infection with the dengue virus and the CHMP’s full indication is: "Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas. The use of Dengvaxia should be in accordance with official recommendations".

As the indication focuses on areas endemic for dengue, the approved indication will not cover individuals living in the EU mainland or many EU territories, apart from those which are situated in endemic areas. In addition, vaccination is currently not recommended for travellers as the laboratory confirmation of any previous infection would not easily be available before vaccination.

Extending this decision to an EU-wide marketing authorisation, which will now be reviewed by the European Commission, will be the next step to increasing patient access to Dengvaxia. The European Commission is expected to grant marketing authorization for Dengvaxia in December 2018. Recent autochthonous cases in Europe (Spain, France, Portugal…) as well as Southern USA point to a rapidly evolving epidemiology of the disease and establishment of the Aedes mosquito in new areas which could herald an additional wave of endemic areas to be considered. Dengue is rapidly spreading and is now the most common mosquito-borne viral disease with over half of the world’s population currently at risk of infection, mainly in tropical areas. Tens of million cases occur each year, of which 20,000-25,000 cases are fatal (most of which are children).

In addition, the FDA’s recent decision to accept a Biologics License Application for Sanofi Pasteur’s dengue vaccine and grant a priority review is a boost in the right direction for reducing the global burden of dengue with this vaccine being currently viewed as a unique preventive tool against dengue and severe dengue which is considered an unmet medical need.

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