Conditional registration of Dengvaxia for use in M'sia


KUALA LUMPUR: The Health Ministry has conditionally registered the world’s first dengue vaccine, Dengvaxia for use in Malaysia.

The vaccine, by French pharmaceutical Sanofi Pasteur contains immunising agents for prevention of the disease caused by four strains of the dengue virus (DEN-1, DEN-2, DEN-3, and DEN-4) circulating in Malaysia.

The National Pharmaceutical Regulatory Agency in a notice published on its website on Thursday revealed that the Drug Control Authority (DCA) has approved Dengvaxia for a post-registration (phase IV) clinical study in Malaysia.

The authorities had given a two-year conditional registration for the vaccine involving volunteers aged nine to 45.

This means that if the study fails to verify the clinical benefit or are not conducted with due diligence, DCA may withdraw this approval.

The notice stated all those who receive the vaccination should bear the cost.

“Subjects that pass study entry screening (for example, not pregnant nor breastfeeding) and have given informed consent will be enrolled into the study.

“During the conduct of this study, any emerging safety signals must be reported to the DCA without delay for further regulatory decisions,” it was stated.

According to the website, the vaccine should be available in the healthcare facilities providing Dengvaxia within the next six months.

It said Dengvaxia would be injected under the skin in the upper arm as a series of three injections at six months interval over the period of one year.

The notice stated that Sanofi Pasteur will commit to conduct a joint study with the Health Ministry and Malaysia to assess the vaccine effectiveness and safety.

It also said the post-registration study design, safety monitoring system and other related conditions will be jointly developed by the Health Ministry and Sanofi Pasteur.

The notice also said the interim study reports should be promptly submitted to the DCA until the full closure of the study.

It noted that Sanofi Pasteur should support the ministry in the public education programme about the approved indication and concerns of the dengue vaccine.

Meanwhile, Academy of Sciences Malaysia senior fellow Professor Datuk Dr Lam Sai Kit said it has been over two years since this vaccine was first approved for use in the Philippines and it is now licensed in 11 countries, including Singapore, Indonesia, and Thailand, and has gone into thousands of children with good safety features.

“Although there are other dengue vaccines in the pipeline, it will be several years before we will know how good they are.

“In the meantime, Dengvaxia will play a significant role in complimenting the existing control measures against this potentially deadly disease. We should see a reduction in the economic burden of this disease nationwide through reduction of cases and hospitalisation.

“I hope that medical health professionals, the relevant ministries and NGOs will help to educate the public of the role of dengue vaccine in the fight against dengue,” he said in a statement today.

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