1) Dengvaxia Powder and Solvent for Suspension for Injection
(Single dose) – MAL16105045ARZ
2) Dengvaxia MD Powder and Solvent for Suspension for Injection
(Multidose) – MAL16105046ARZ
The Drug Control Authority (DCA) has decided to register Sanofi Pasteur’s dengue vaccine, Dengvaxiaat it’s meetings in Putrajaya on 31st October 2016 and 25th November 2016. Dengvaxia was approved by DCA only for post-registration (Phase IV) study in Malaysia. It is a conditional registration for two (2) years.
The specific registration conditions imposed on Dengvaxia are as follows:
1. Dengvaxia is approved by DCA only for post-registration (Phase IV) study in Malaysia. This conditional registration is for two years. If the study fails to verify the clinical benefit or are not conducted with due diligence, DCA may withdraw this approval.
2. Sanofi Pasteur will commit to conduct a joint study with the Ministry of Health (MOH), Malaysia to assess vaccine effectiveness and safety. The study details will be further discussed by both parties.
3. The post-registration study design, safety monitoring system and other related conditions will be jointly developed by MOH and Sanofi Pasteur.
4. All vaccinees must bear the cost of vaccination. Subjects that pass study entry screening (e.g. not pregnant nor breastfeeding) and have given informed consent will be enrolled into the study.
5. During the conduct of this study, any emerging safety signals must be reported to the DCA without delay for further regulatory decisions.
6. The interim study reports must be promptly submitted to the DCA until the full closure of the study. The final study report must then be submitted to the DCA.
7. Sanofi Pasteur will commit to support the MOH in the public education programme about the approved indication and concerns of the dengue vaccine.
Frequently Asked Question ( FAQ )
What is registered?
What are the conditions of registration?
Why is this a conditional registration?
Although the vaccine confers protection regardless of previous exposure to dengue, the major studies reported that DengvaxiaTM confers significantly better protection to vaccinees with prior dengue infection (81.9%), compared to those without previous dengue infection (52.5%). There is currently limited information on risks of DengvaxiaTM vaccination on adults without previous dengue infection, as the efficacy clinical studies were only conducted in children up to 16 years old.
The current evidence on the efficacy and safety of DengvaxiaTM comes from clinical studies involving over 40,000 human subjects, including two major studies in children aged 2-16 years living in dengue-endemic countries across Asia and Latin America. These major studies reported different vaccine efficacy in reducing dengue incidence, i.e. the vaccine is less effective in reducing dengue incidence caused by DEN1 (58.4%) and DEN2 (47.1%), compared to other strains, DEN3 (73.6%) and DEN4 (83.2%).
How will a conditional approval affect the availability of Dengvaxia?
The vaccine should be available in the healthcare facilities within the next 6 months.
Who can use Dengvaxia?
How to use Dengvaxia?
How can I get vaccinated against dengue?
What are the side effects of DengvaxiaTM?
Serious allergic reactions are very rare (may affect up to 1 in 10,000 people), after receiving any vaccine. The symptoms include difficulty in breathing, swelling of the face or throat, and low blood pressure causing dizziness or collapse. You must consult a doctor immediately if this occurs.
During DengvaxiaTM marketing in Malaysia, NPRA will monitor its use closely to ensure continued effectiveness and safety. Please inform your doctors or report any side effect to the National Centre for Adverse Drug Reaction Monitoring by calling 03-78835550, or visiting http://npra.moh.gov.my/index.php/reporting-consumer
What else should I know?
Who should I contact for any enquiry related to DengvaxiaTM?