Lyon, France – February 5, 2016 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that El Salvador has granted regulatory approval to Dengvaxia®, representing the fourth successful licensure of the dengue vaccine in two months. Dengvaxia® was approved in Mexico, the Philippines and Brazil in December of last year.
The regulatory authorities in El Salvador approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas.
Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the study participants 9 years and older and to prevent 8 out of 10 hospitalizations due to dengue and up to 93% of severe dengue cases in this age group.1
“Approval of the much-needed Dengue vaccine is welcome news for our country,” said Dr. Lourdes Dueñas de Chicas, Infectious Disease Specialist at the Hospital del Niño Benjamín Bloom in El Salvador and President of the Infectious Disease Association from El Salvador “Our dengue burden has grown every year for the last decade. Severe cases have increased as well as hospitalizations, which cause serious public health problems. Access to this vaccine is essential to boost and strengthen our other dengue prevention efforts in El Salvador and bring down our disease burden here. We believe that this approval has been timely and precise.”
“This latest approval of Dengvaxia® in El Salvador shows the speed with which we are moving to make dengue a vaccine-preventable disease in countries where the disease burden is the highest,” says Dr. Cesar Mascareñas, Head of Global Medical Affairs, Sanofi Pasteur. “This is great news for the people of El Salvador and it is great news for the value of this new public health approach to bring an innovative vaccine first to people living with the highest disease risk where the vaccine can, in fact, have the greatest impact.”
The annual incidence of reported dengue in El Salvador has ranged between 90/100,000 (2008) and 845/100,000 (2014) in the past 10 years.2 All four types of dengue are found in the country and dengue incidence increased precipitously in the last two reporting years, reaching 49,396 reported cases in 2015.3,4
Up to 60% of dengue cases in El Salvador are reported in individuals over 9 years of age, a highly mobile and socially-active segment of the population who contributes to the spread of the disease within communities and across regions.5
The Pan American Health Organization (PAHO) reported 2,317,354 cases of dengue in the Americas in 2015; 1,917,997 or almost 83% of the total reported cases occurred in the countries where the Dengue vaccine is currently approved: Brazil, Mexico and El Salvador.6