European regulator recommends Sanofi’s dengue vaccine
SAN JUAN – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of biopharmaceutical company Sanofi Pasteur’s dengue vaccine, recommending its approval in Europe.
According to the Associated Press, the recommendation comes “despite concerns about the vaccine’s wide use and a lawsuit in the Philippines alleging that it was linked to three deaths.”
A person can get dengue more than once as there are four distinct virus serotypes circulating worldwide. Secondary dengue infections tend to be worse than the first.
The vaccine, known as Dengvaxia, is currently licensed in 20 countries. The indication for the dengue vaccine recommended by the CHMP is for use in prevention of dengue caused by virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue infection.
“Sanofi previously warned that people who had never been sickened by dengue were at risk of more serious disease after receiving the vaccine. The company said it expected to take a 100 million-euro ($118 million) loss based on that news,” the AP reports.
Dengue fever is a debilitating disease typically leading to prolonged fever and severe joint pain. Dengue infection can progress unpredictably to a life-threatening form of the disease called dengue hemorrhagic fever that often requires hospitalized care. There is no specific treatment available for dengue disease.
The dengue vaccine has been “evaluated in studies involving more than 40,000 people from 15 countries with up to six years of follow-up data from large-scale clinical safety and efficacy investigations,” according to Sanofi, which said European Commission approval of the vaccine is expected in December.
“This is good news for people living in dengue-endemic parts of the European territories where frequent outbreaks could put them at risk of re-infection with another dengue virus serotype, which is often more severe than the first infection,” said Su-Peing Ng, global medical head at Sanofi.