Malaysia okays dengue vaccine… with conditions

Vacina-DenguePETALING JAYA: The world’s first dengue vaccine will soon be available in Malaysia, after the health ministry gave conditional registration for a two-year clinical study to gauge the vaccine’s effectiveness.

According to a notice on the National Pharmaceutical Regulatory Agency’s website, issued by the Drug Control Authority (DCA), the ministry will conduct the study together with French pharmaceutical company Sanofi Pasteur, which produced the vaccine.

DCA said the vaccine, known as Dengvaxia, was given approval for a post-registration (phase IV) study involving volunteers aged nine to 45, meaning that only those who participate will be able to access the vaccine.

All participants will bear the cost of vaccination, which consists of three injections six months apart over the period of one year.

DCA added that if the study failed to verify the vaccine’s clinical benefit, or was not conducted with due diligence, it would withdraw the approval.

According to the notice, pharmaceutical products are usually approved for five years. DCA said full registration for Dengvaxia could be considered if the vaccine was proven safe and effective after the initial two-year period.

Although Dengvaxia provides protection regardless of previous exposure to dengue, DCA said major studies reported that the vaccine gave significantly better protection to those who had been infected before (81.9%) compared to those who had never had dengue (52.5%).

DCA added that there was limited information available at present on the risks of the Dengvaxia vaccination on adults who had never been infected with dengue. This was because previous efficacy clinical studies had concentrated on children up to 16 years old.

It also cited major studies showing that Dengvaxia was less effective in reducing the incidence of dengue caused by DEN1 (58.4%) and DEN2 (47.1%), compared to other strains, DEN3 (73.6%) and DEN4 (83.2%).

Current evidence on the vaccine’s safety and efficacy comes from clinical studies involving over 40,000 participants. DCA said this included two major studies on children aged two to 16 living in dengue-endemic countries across Asia and Latin America.

Last September, Health Minister S Subramaniam said the ministry believed Dengvaxia could make people sick instead of protecting them. This was despite the vaccine receiving the approval of the World Health Organisation (WHO).

Subramaniam cited US studies which indicated the dangers of vaccinating those who had not yet been exposed to dengue.

A total of 93,871 Malaysians contracted dengue between January and November last year. Of that number, 271 died.