The EMA Committee for Human Medicinal Products (CHMP) has adopted a positive opinion for the quadrivalent dengue vaccine (live attenuated) QDENGA® (TAK-003) of the company Takeda, used to prevent the disease caused by serotypes 1, 2, 3 and 4 of the dengue virus in people from four years of age.
Dengue is a mosquito-borne tropical disease caused by four types of the dengue virus, which causes mild flu-like symptoms in most people. However, a small number of patients develop severe disease, with life-threatening bleeding and organ damage. The risk of severe illness 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 mortality rate of 20,000 to 25,000 per year, mostly in children. Before 1970, only nine countries had experienced serious 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 travelers returning from low- and middle-income countries.
Today dengue is endemic in more than 100 countries, including Europe. It is the second most diagnosed cause of fever among travelers after malaria.
This is the first time that the CHMP has simultaneously reviewed a medicine destined for the European Union (EU) market, under the centralized procedure, and for non-EU countries, under the ‘EU-Medicines for all’ programme, or EU- M4all. The EMA initiative to support parallel applications for the EU-M4all opinion and the centralized procedure aims to make innovative or generic medicines and vaccines that address unmet medical needs or are of high public health interest available in Europe and around the world faster, avoiding duplication of efforts by regulators.
Quadrivalent Dengue Vaccine Offers Greater Protection
Currently, no antiviral therapy is available for dengue virus infection, and most current measures based on mosquito control are not very effective in preventing the disease. There is already an approved vaccine, but the quadrivalent dengue vaccine shows broader protection for young children and people over 45 years of age. In light of this, an unmet global public health need is being addressed.
The positive opinion of the Committee was supported by the results of five phase 1, 2 and 3 trials with more than 28,000 children and adults. This includes four and a half years of follow-up data from the pivotal global Phase 3 Tetravalent Immunization Against Dengue Efficacy Study. The benefits and safety of the current vaccine were evaluated in 19 clinical trials involving more than 27,000 people aged 15 months to 60 years, from endemic and non-endemic regions. Study results show that quadrivalent dengue vaccine prevents fever, severe illness, and hospitalization caused by any of the four dengue virus serotypes.
Exploratory analyzes of TIDES showed that during the four and a half years of study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the general population, including seropositive people and seronegative. TAK-003 has been generally well tolerated, with no evidence of disease improvement in vaccine recipients, and no major safety risks have been identified in the TIDES trial to date.
The most frequently reported suspected adverse events after any dose of this vaccine were injection site pain, headache, muscle pain, and malaise.
“We are one step closer to the approval of a dengue vaccine that could benefit many of the millions of people exposed to dengue around the world. This is an important moment for the global health community, European countries, and dengue-endemic countries that participated in the EU-M4all procedure,” said Gary Dubin, MD, president of Takeda’s Global Vaccines Business Unit.
Medicines submitted under the EU-M4all program are evaluated by the CHMP in collaboration with the WHO and target countries, combining the scientific review capabilities of the EMA with the epidemiology and local disease expertise of the WHO and national experts and regulators. in the target countries. The CHMP scientific opinion under the EU-M4All procedure supports the development of global regulatory capacity and contributes to the protection and promotion of public health beyond the EU by evaluating 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.
The company notes that marketing authorization is expected in the coming months in Europe, followed by regulatory decisions in Latin America and Asia. For now, this vaccine is only officially approved in Indonesia.
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