The European Medicine Agency’s human medicine committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine, which is used to prevent disease caused by dengue virus serotypes 1, 2, 3, and 4 in people from 4 years of age.
Dengue is a mosquito-borne disease caused by four types of the dengue virus that leads to mild, and flu-like symptoms in most people. However, a smaller number of patients develop serious disease, with fatal bleeding and organ damage. The risk of serious dengue disease is higher in people who have been infected by the virus for a second time.
According to the World Health Organization (WHO), there are around 390 million dengue cases per year worldwide, with an estimated death rate of 20,000 to 25,000 people per year, particularly in children. Dengue is the second most diagnosed cause of fever after malaria among people returning from low and middle-income nations.
This is the first time the CHMP is simultaneously reviewing a medicinal product meant for the European market. This initiative of the European Medicines Agency (EMA) to support parallel applications for the EU-M4all opinion aims to make generic medicines and vaccines that address unmet medical needs in Europe.