Malaysia’s DCA Conditionally Approves Takeda’s Qdenga Dengue Vaccine – CodeBlue

KUALA LUMPUR, Feb 9 – Malaysia’s Drug Control Authority (DCA) has given conditional approval for use of Takeda’s Qdenga dengue vaccine to prevent dengue fever in individuals aged four years and older.

The live attenuated dengue tetravalent vaccine by the Japanese pharmaceutical company is manufactured by Takeda GmbH in Germany, while the product registration holder is Takeda Malaysia Sdn Bhd.

“This product has been agreed for conditional registration as the DCA is satisfied with evaluation on the efficacy, safety, and quality of the product, while monitoring will be conducted by the product registration holder after registration of the product,” Health director-general Dr Muhammad Radzi Abu Hassan said in a statement today, after the DCA’s 393rd meeting held yesterday.

“Through this conditional registration, the product registration holder 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.”

The Health DG did not state if the Qdenga dengue vaccine would be made available in public health care facilities.

The Ministry of Health (MOH) reported 123,133 dengue cases nationwide in 2023, up by a whopping 86 per cent from 66,102 cases in 2022, according to Dr Muhammad Radzi’s January 5 statement. Deaths from dengue fever increased by 79 per cent to 100 in 2023 from 56 the previous year.

According to the MOH’s latest dengue report for the fifth epidemiological week of the year (January 28 to February 3), 180 dengue hotspots were reported, up from 148 localities the previous week. The majority of the 180 dengue hotspots was in Selangor with 143 localities, followed by 20 hotspots in Kuala Lumpur.

In October 2023, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended the use of Takeda’s Qdenga vaccine in settings with high dengue disease burden and high transmission intensity.

Emeritus Professor Dr Lam Sai Kit, a research consultant at Universiti Malaya and senior fellow at the Academy of Sciences Malaysia, previously called for the licensing of the Qdenga dengue vaccine in Malaysia.

He pointed out that unlike Sanofi’s Dengvaxia vaccine, there is no requirement for pre-vaccination testing with Qdenga as the vaccine has been approved for use regardless of prior dengue exposure.

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