EMA's human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue virus serotypes 1, 2, 3 and 4 in people from four years of age.
Dengue is a mosquito-borne tropical disease caused by four types of the dengue virus, leading to mild, flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The risk of severe disease is higher in people who have been infected a second time.
According to the World Health Organization, there are approximately 390 million dengue infections per year worldwide, with an estimated death rate of 20,000 to 25,000 per year, primarily in children. Before 1970, only nine countries had experienced severe dengue epidemics, while today the disease is endemic in more than 100 countries, including in Europe. It is the second most-diagnosed cause of fever after malaria among travellers returning from low- and middle-income countries.
This is the first time the CHMP simultaneously reviews a medicinal product meant for the European Union (EU) market, under the centralised procedure, and non-EU countries, under the 'EU-Medicines for all' programme - or EU-M4all. EMA's initiative to support parallel applications for the EU-M4all opinion and the centralised procedure aims to make innovative or generic medicines and vaccines that address unmet medical needs or are of major public health interest available in Europe and globally faster, while avoiding duplication of efforts from regulators.
An antiviral therapy for dengue virus infection is not available, and most of the current measures that rely on mosquito control are not very efficient in preventing disease. There is an already approved vaccine, but the dengue tetravalent vaccine shows a wider protection for young children and people older than 45 years old. In light of this, a global unmet public health need is being addressed.
The benefits and safety of the current vaccine have been evaluated in 19 clinical trials that enrolled more than 27,000 people aged between 15 months and 60 years, from both endemic and non-endemic regions. The results of the studies show that dengue tetravalent vaccine prevents fever, severe disease and hospitalisation caused by any of the four serotypes of the dengue virus.
The most frequently reported suspected adverse events after any dose of this vaccine were injection site pain, headaches, muscle pain and feeling generally unwell.
Medicines submitted under the EU-M4all programme are assessed by the CHMP in collaboration with the WHO and the target countries, combining EMA's scientific review capabilities with the epidemiology and local disease expertise of WHO and experts and national regulators in the target countries. The CHMP scientific opinion under the EU-M4All procedure supports global regulatory capacity building and contributes to the protection and promotion of public health beyond the EU by assessing medicines for countries where regulatory capacity may be limited. National regulators can rely on the CHMP's scientific assessment to decide on the use of the medicine in their countries.