Update May 1, 2019: The US Food and Drug Administration (FDA) approved the use of Dengvaxia for children ages 9-16.
Dengvaxia is a live attenuated tetravalent chimeric vaccine made using recombinant DNA technology by replacing the PrM (pre-membrane) and E (envelope) structural genes of yellow fever attenuated 17D strain vaccine with those from the four dengue serotypes.
Dengvaxia is approved for use in several endemic countries in Latin America and Asia, where reducing the human and economic burden of dengue is critical.
The US Food and Drug Administration (FDA) approved the use of Dengvaxia for children ages 9-16 and is considered a significant medical advance in the prevention of dengue, which is considered an unmet medical need by the FDA.
The European Commission has granted marketing authorization for Dengvaxia, Sanofi’s dengue vaccine. The marketing authorization follows the October 18, 2018, recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve the use of the dengue vaccine in European endemic areas.
Dengvaxia will be available in Europe to prevent dengue disease in individuals 9-45 years of age with a documented prior dengue infection and who are living in endemic areas.
“In some of the European overseas territories where dengue recurs regularly, people who have had a dengue infection previously are at risk of being infected with the virus again,” explains Dr. Su-Peing Ng, Global Medical Head at Sanofi Pasteur, the vaccine unit of Sanofi. “As the second infection with dengue tends to be more severe than the first, it is important to be able to offer these people a vaccine that could help protect them against subsequent dengue infections.”