Follow Us: social media social media social media    Language :           

Conditional Registration Of A Dengue Vaccine For Use In Malaysians 9 - 45 Years Of Age

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?

The Drug Control Authority (DCA) has conditionally registered Sanofi Pasteur’s dengue vaccine, DengvaxiaTM on 31st October 2016. DengvaxiaTM is the world’s first dengue vaccine which contains immunising agents for prevention of disease caused by four (4) strains of dengue virus (DEN-1, DEN-2, DEN-3, and DEN-4) circulating in Malaysia. 

What are the conditions of registration?

Rather than the usual product registration period of five (5) years in Malaysia, DengvaxiaTM is given a conditional registration for two (2) years to enable conduct of a post-registration (phase IV) study in Malaysia. The full registration can be considered after two (2) years with current available evidence on vaccine effectiveness and safety.

Why is this a conditional registration?

There is still further need to assess the vaccine effectiveness and safety.

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?

All vaccinees must bear the cost of vaccination. Vaccine will be available through healthcare facilities that are providing DengvaxiaTM to their vaccinees.

The vaccine should be available in the healthcare facilities within the next 6 months. 

Who can use Dengvaxia?

DengvaxiaTM is indicated for use only in Malaysians from 9 to 45 years old who wish to be vaccinated against dengue. There is a concern that vaccinees especially in young children below 9 years old without previous dengue infection may have an increased risk of developing a more severe dengue infection if they get infected with dengue later. At the moment, there is insufficient clinical evidence to support vaccination in Malaysians over 45 years old. Hence, there is a warning against use in children less than 9 years old and adults older than 45 years old due to incomplete understanding on risks of vaccination in these populations.Before vaccination, you must be assessed by your doctor to determine if DengvaxiaTM is suitable for you. You cannot take the vaccine if you are allergic to its contents, you suffer from a disease with mild to high fever or an acute disease, you have a weakened immune system (for example due to a genetic defect, HIV infection or therapies that affect the immune system), you are pregnant or breastfeeding.

How to use Dengvaxia?

DengvaxiaTM is injected under the skin in the upper arm as a series of three (3) injections at 6 months interval over the period of one (1) year. 

How can I get vaccinated against dengue?

Malaysians interested to get vaccinated should consult doctors on the benefits and risks prior to vaccination. Sanofi Pasteur which markets DengvaxiaTM in Malaysia has committed to providing educational materials detailing the approved use and limitations of the vaccine. It is essential that vaccinees make informed decisions on vaccination upon discussing with doctors. All vaccinees will be enrolled in the immunization registry to support vaccination compliance and long–term monitoring. During this two year period, all adverse events are collected, monitored and reported to the DCA. Regulatory actions can be taken if there are major safety issues.

What are the side effects of DengvaxiaTM?

Very common side effects (may affect more than 1 in 10 users) and usually occur within three (3) days after an injection are headache, muscle pain, generally feeling unwell, feeling of weakness, injection site pain, and fever.
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?

As with all vaccines, Dengvaxia may not protect 100% of persons who have been vaccinated. Further, dengue vaccination is not a substitute for protection against mosquito bites. You should take appropriate precautions to prevent mosquito bites, including maintaining a clean living environment while avoiding mosquito breeding grounds, use of mosquito repellents, adequate clothing, and mosquito nets.

Who should I contact for any enquiry related to DengvaxiaTM?

Please contact your regular Health Care Professionals for further information on DengvaxiaTM.

For Health Care Professionals for any questions related to DengvaxiaTM kindly contact Sanofi representatives at Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. or +603 – 7651 0800.

qrcode