MANILA – The Department of Health on Friday said the anti-dengue vaccine Dengvaxia may be connected to three deaths, in the wake of a government-ordered inquiry, and that the drug is not ready for mass immunization.
Three cases of recent dengue deaths were found to have “causal association” with Sanofi’s Dengvaxia vaccine.
“They died of dengue even (though) they were given Dengvaxia. Two of them may have died because of vaccine failure,” Department of Health Undersecretary Enrique Domingo told a news conference Friday.
French drug maker Sanofi revealed in November that Dengvaxia – the world’s first dengue vaccine – might increase the risk of severe disease in people who had never been exposed to the virus. The news prompted an uproar in the Philippines, where more than 800,000 school-age children had been vaccinated in 2016.
Sanofi officials were not immediately available for comment on the government announcement.
The Philippine Health Ministry halted Dengvaxia immunizations in November. It formed a 10-member panel of experts to determine if the drug was directly connected to the deaths of 14 children after they were given the vaccine.
It found it may have been connected to the deaths of three.
“These findings strengthen the decision of the Department of Health to stop the vaccine. It has failed in some children. Dengvaxia is not ready for mass vaccinations and we would need three to five more years to watch and monitor if there would be other adverse reactions from the vaccine.”
Mosquito-borne dengue is the world’s fastest-growing infectious disease, afflicting up to 100 million people worldwide, causing half a million life-threatening infections and killing about 20,000 people, mostly children, each year.
Domingo said the panel’s findings would be shared with the justice department, which is considering cases against those responsible for the mass immunization program.
Pediatrician and panel member Juliet Sio-Aguilar, from the University of the Philippines-Philippine General Hospital, said the team was recommending further studies as it was difficult to directly connect the three deaths to Dengvaxia.
No vaccine has a 100 percent success rate, she said. The dengue death rate in the Philippines was 60 times higher than global rate, Sio-Aguilar said.
The government spent PhP3.5 billion ($68 million) on the Dengvaxia program in the campaign to reduce the 200,000 dengue cases reported every year.
Authorities have already fined Sanofi a symbolic $2,000, citing violations in product registration and marketing.