The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has delivered a favourable opinion for "Dengue Tetravalent Vaccine (live, attenuated) Takeda". Takeda Pharma's vaccine is intended for use in individuals aged four years and older to prevent diseases caused by dengue virus serotypes 1, 2, 3 and 4. For the first time, under the EU-Medicines for all programme, the centralised procedure for evaluation of a medicinal product for EU countries was carried out simultaneously with the review for non-EU countries. The European Commission approved the authorisation on 5 December 2022.
Dengue fever, which is a disease transmitted by mosquitoes, usually leads to mild, flu-like symptoms. In rare cases, especially in people who are infected for the second time, the disease is more severe, with potentially fatal bleeding and organ damage.
According to the World Health Organization (WHO), there are around 390 million dengue fever infections worldwide every year. The death rate is between 20,000 and 25,000 and primarily affects children. After malaria, dengue fever is the second most commonly diagnosed cause of fever among travellers returning from low- and middle-income countries. The infectious disease is endemic in more than 100 countries worldwide – including Europe.
Measures against dengue virus infection have so far been based primarily on mosquito control efforts and personal protection against mosquito bites, but they are not very effective. There is no targeted antiviral therapy for dengue virus infections. The vaccine Dengvaxia, which was approved in 2018, is approved for people between the ages of 9 and 45 who have been infected with the dengue virus in the past and live in endemic areas.
The new tetravalent dengue vaccine from Takeda Pharma now offers protection against the infectious disease to young children and people over 45 years of age as well. The benefits and safety of the vaccine have been assessed in 19 clinical trials involving more than 27,000 people aged between 15 months and 60 years from endemic and non-endemic regions.
The results of the studies show that the tetravalent attenuated live vaccine prevents severe illness and hospitalisation in infections caused by all four serotypes of the dengue virus fever. The most frequently reported suspected adverse reactions after a dose of the vaccine were injection site pain, headache, muscle pain and general malaise.
The CHMP has for the first time examined a medicinal product intended for the EU market parallel to a review for non-EU countries under the EU-Medicines for all (EU-M4all) programme. Medicinal products submitted under the EU-M4all programme will be evaluated by the CHMP in cooperation with the WHO and the target countries. The advantage of this procedure lies in the combination of the expertise of the CHMP, the WHO and the regulatory authorities of the target countries. National regulatory authorities may use the scientific assessment of the CHMP to decide on the use of the medicinal product in their country. The aim of this EMA/WHO initiative is to accelerate the availability of innovative medicines and vaccines in Europe and worldwide, while avoiding duplication of regulatory efforts.
Updated: 05.12.2022
