The Drug Control Authority (DCA) has granted conditional approval to Takeda’s Qdenga dengue vaccine, making it available for individuals aged four and above. The vaccine has been recommended by the Strategic Advisory Group of Experts on Immunization, advising the World Health Organization, as a means to shield the youth from the significant public health menace posed by dengue fever.
The health ministry has reported an alarming 86.3% spike in the number of dengue cases in 2023, totaling 123,133 reported cases and 100 deaths due to complications from dengue. In response to this surge, the approval of the Qdenga vaccine comes as a crucial development in combatting the spread of dengue fever.
Health director-general Radzi Abu Hassan emphasized that the conditional approval was granted after rigorous tests on the vaccine’s effectiveness, safety, and product quality. The product registration holder (PRH) will be responsible for monitoring the vaccine post-registration, ensuring ongoing data submission on its effectiveness and safety to maintain a positive ‘benefit over risk’ ratio.
Manufactured by Takeda GmbH in Germany, with Takeda Malaysia Sdn Bhd as the PRH in Malaysia, the Qdenga vaccine’s availability in public healthcare facilities remains uncertain. Nevertheless, this milestone approval marks a significant step in addressing the pressing public health concern of dengue fever in the country.
As the nation grapples with the alarming rise in dengue cases, the approval of Takeda’s Qdenga dengue vaccine offers a glimmer of hope in the ongoing battle against this debilitating disease.
