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Sanofi has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the EMA's CHMP
In a Dec. 19, 2018 press release, Sanofi revealed that it has been granted marketing authorization by the European Commission for its dengue vaccine, Dengvaxia, following the earlier recommendation of approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
This marketing authorization will mean that European patients aged 9–45 years with prior dengue infection, who are living in endemic areas, will be able to receive the preventative treatment, Dengvaxia.
“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,” explained 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.”
The dengue vaccine is currently approved for use in several endemic countries in Latin America and Asia and is under priority review by FDA.