BILLEV PHARMA EAST

NEWS

20 October 2022

The CHMP recommended granting marketing authorisation for Dengue Tetravalent Vaccine

The CHMP recommended granting marketing authorisation for Dengue Tetravalent Vaccine for the prevention of dengue virus serotypes 1, 2, 3, and 4 in people from four years of age. Dengue viruses are spread to people through the bite of an infected Aedes species (Ae. aegypti or Ae. albopictus) mosquito. These mosquitoes also spread Zika, chikungunya, and other viruses. Dengue leads to mild flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. Each year, up to 400 million people get infected with dengue. Approximately 100 million people get sick from infection, and 40,000 die from severe dengue. This vaccine received an EMA recommendation under the EU Medicines for all (EU-M4All) program, a mechanism that allows the CHMP to assess medicines that are intended for use in low- and middle-income countries outside of the European Union (EU). Simultaneously, the vaccine has also received a positive opinion for use in the EU.