2022-12-09| Trials & Approvals

Takeda’s Dengue Vaccine Wins European Approval

by Joy Lin
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Takeda’s Qdenga has become the second dengue vaccine to be approved in the European Union (EU), after Sanofi’s Dengvaxia. 

The nod follows the positive opinion adopted in October by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 

Qdenga will be used to protect against dengue disease in individuals aged four and older. 

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Qdenga Prevents 80% of Symptomatic Dengue

A tetravalent vaccine, Qdenga guards against the four serotypes of the virus that causes dengue fever. Dengue incidence has become increasingly prevalent in the last two decades, driven by climate change and urbanization. It is the leading cause of fever in travelers returning to Europe from endemic countries. 

The EU nod for Qdenga is based on results across 19 Phase 1, 2, and 3 trials in more than 28,000 children and adults as well as 4.5 years of follow-up data from the pivotal Tides trial. The Tides study showed that Qdenga was 80.2% effective in preventing symptomatic dengue cases 12 months after vaccination. Qdenga was also shown to prevent 90.4% of hospitalizations 18 months after vaccination. After 4.5 years of follow-up, Qdenga prevented 84% of hospitalized dengue cases and 61% of symptomatic cases in the overall population. 

No Evidence Of Disease Enhancement

Disease enhancement has been a concern regarding dengue vaccines. Dengvaxia, the first approved dengue vaccine, was found to increase the risk of severe diseases such as hemorrhagic fever due to a rare condition called antibody-dependent enhancement (ADE). In ADE, vaccination induces antibodies to bind to the virus. But instead of neutralizing it, the antibodies actually increase the virus’ ability to enter cells, making the infection worse.

According to Takeda, the shot was generally well-tolerated and there was no evidence of disease enhancement or other major safety risks in the vaccinated. 

Besides the EU, Qdenga has been approved in Indonesia, with a rollout expected to begin next year. Regulatory filings in other dengue-endemic countries in Asia and Latin America are ongoing, said Takeda. 

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