The vaccine, TAK-003, was endorsed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the prevention of dengue disease caused by any serotype in individuals four years of age and older.
The shot was evaluated through the EMA’s first-ever parallel assessment of a medicinal product for use in the EU and non-EU countries through the EU-M4all procedure. This gives participating regulatory agencies, many of which are from dengue-endemic countries, a scientific foundation for making their own regulatory decisions.
Medicines submitted under the EU-M4all program 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.
Over half of the world’s population – nearly 4 billion people – are at risk of contracting dengue annually and currently, there isn’t an effective preventative option for individuals regardless of prior exposure to the disease, according to data from the World Health Organization (WHO).
Dengue is the second most diagnosed cause of fever in travelers returning to Europe from endemic countries, and severe dengue is a leading cause of serious illness and death among children in Latin America and Asia, as per the WHO data.
The CHMP said its positive opinion on TAK-003, which is branded as Qdenga, was supported by results across five Phase 1, 2 and 3 trials which included more than 28,000 children and adults. This includes 4.5 years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES).
Takeda said EMA arketing authorization for the vaccine is expected in the coming months followed by regulatory approvals in dengue-endemic countries in Latin America and Asia. Qdenga has already been approved in Indonesia.
Dengue vaccine deal
Looking to dengue targeted R&D work globally, and in July, we reported that UK vaccine company, Emergex, had signed a collaborative deal with the Molecular Biology Institute of Paraná (IBMP) in Brazil, with the partnership covering dengue, COVID-19, and Chikungunya vaccines.
The agreement involves a shared clinical development phase as well as allowing IBMP exclusive rights for the commercialization of the vaccine candidates in Brazil. In addition, clinical stage manufacturing of the vaccines will be conducted by Emergex; with a transition to commercial scale manufacturing being conducted in the region by IBMP.
The alliance will initially focus on Emergex’s dengue vaccine candidate, which is currently in Phase 1 clinical trials in Switzerland with top line results expected imminently. This represents one of the UK firm’s most advanced candidates using its 100% synthetic T cell adaptive vaccine approach, with the dengue vaccine showing potential to be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever.
Emergex also champions the potential of its vaccine candidates to be stable at ambient temperatures, reducing the burden and logistics of administration.