SAFETY, EFFICACY AND QUALITY DATA OF DENGUE VACCINE UNDER REVIEW

The Ministry of Health Malaysia (MOH) takes note of the recent registration of the dengue vaccine in Mexico and would like to inform the Malaysian public that the manufacturer has similarly submitted documents for the same vaccine to be registered here in Malaysia. The Drug Control Authority under the MOH has convened several meetings to review the data submitted from the aspects of safety, efficacy and quality; and will be ready to make a conclusion on the registration by the mid 2016.

If the vaccine is registered in Malaysia, the Public Health Programme MOH will conduct a thorough review of the cost effectiveness of introducing the vaccine as a national policy; taking into account cost of the vaccine, cost of intervention, cost of treatment, circulating serotype, epidemiology, loss of productivity and the overall impact of the vaccine on the disease.

Given that the epidemiology and dominant circulating virus serotype are different between countries, the vaccine will show different impact levels in different countries because of the different vaccine efficacy towards each of the four (4) serotypes i.e. 58.4% for DEN1, 47.1% for DEN2, 73.6% for DEN3 and 83.2% for DEN4.

Once again, the public is reminded that with the overall 65.6% efficacy of the vaccine, it will just be an additional tool in the multi pronged approach to dengue prevention and control. Community involvement in source reduction and general cleanliness remains the number one intervention tool in our fight against dengue.

DATUK DR. NOOR HISHAM BIN ABDULLAH
Director General of Health Malaysia
Ministry of Health Malaysia
12th December 2015

Source : MoH