Health director-general Dr Muhammad Radzi Abu Hassan has announced the conditional approval of Takeda’s Qdenga dengue vaccine to those aged four and above.
In a statement by the Health Ministry, Radzi said the vaccine had been conditionally approved for registration after the Drug Control Authority (DCA) was satisfied with tests on its effectiveness, safety and product quality.
The statement did not. indicate whether it would be made available in public healthcare facilities.
“Through this conditional registration, the product registration holder (PRH) is required to produce monitoring data on the efficacy and safety of the Qdenga vaccine, from time to time, after use in the Malaysian market.
“This will enable the NPRA (National Pharmaceutical Regulatory Agency) to make continuous monitoring on both such aspects to ensure that the benefit over risk for the Qdenga vaccine remains positive," he said.
The vaccine is manufactured by Japanese pharmaceutical company Takeda GmbH in Germany, with Takeda Malaysia Sdn Bhd as the PRH in Malaysia.
Last month, the Health Ministry reported a significant increase of 86.3 percent in dengue cases in 2023.
There were 123,133 reported cases last year compared to 66,102 cases in 2022, and 100 fatalities in 2023 compared to 56 in 2022. - Mkini
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