The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Sanofi’s tetravalent vaccine, Dengvaxia, for the prevention of dengue caused by dengue virus serotypes 1, 2, 3, and 4 in people who are between 9 and 45 years old, live in an endemic area, and already had a prior dengue virus infection. Approval of the vaccine, which would be the first for dengue virus cleared in the EU, is expected in December.
The most common mosquito-borne viral disease affecting people worldwide, dengue is seen primarily in tropical areas; tens of millions of cases occur each year resulting in approximately 20,000-25,000 deaths, mainly in children.1
Dengvaxia was evaluated in 31 clinical studies, conducted mostly in Latin America and the Asia Pacific. The trials included over 41,000 participants aged 9 months to 60 years receiving at least one dose of the vaccine. The data demonstrate that for people between 9 and 45 years of age, the vaccine has positive effects in preventing symptomatic and severe dengue disease in people who have had previous dengue infection and live in endemic areas. In people who have never had dengue, there is an increased risk of clinically severe dengue disease leading to hospitalization. Therefore, The CHMP recommends limiting the use of the vaccine to individuals with prior dengue virus infection, for whom laboratory confirmation of the previous infection is available before vaccination.
The approved indication excludes the populations of the EU mainland and territories outside tropical areas since dengue is not endemic in these regions. However, a number of EU territories, mainly overseas, are situated in endemic areas, and these territories could benefit from this vaccine.
In December, authorities in the Philippines suggested that several children who had died after receiving Dengvaxia exhibited signs of “severe dengue.” However, Sanofi denied that there were any deaths related to its vaccine in the Philippines.
The CHMP opinion is a first step for Dengvaxia. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization, and then decisions about price and reimbursement will be made.
(Source: The European Medicines Agency)