MANILA, Philippines — The Department of Health (DOH) is looking into the possibility of requiring the manufacturer of the world’s first dengue vaccine to refund the government following reports that the treatment poses risks to people without a history of dengue.
“It is an option we are considering, but we also have to look into the legal issues,” Health Undersecretary Gerardo Bayugo told reporters yesterday.
The controversy on the P3.5-billion dengue immunization program broke after pharmaceutical giant Sanofi Pasteur disclosed that new clinical analysis found its Dengvaxia vaccine effective for people who have had dengue prior to immunization, but noted the risk of a “severe” case of dengue for people who have not.
Bayugo clarified that there had been no apparent irregularity in the purchase of Dengvaxia until Sanofi admitted that the vaccine only provides protection for those previously afflicted with dengue.
He explained that the DOH’s decision to implement a dengue immunization program was based on the previous findings that Dengvaxia was safe for use, and there was no complaint before the Commission on Audit concerning its purchase.
“I still believe that the DOH complied with the requirements of the law in the procurement of the dengue vaccine,” he added.
Dengvaxia was duly registered with the Food and Drug Administration (FDA) when the DOH purchased it.
The DOH also complied with the guidelines of the World Health Organization (WHO) that only areas with high dengue prevalence shall be covered by the program.