A government inquiry has found that Sanofi's dengue vaccine Dengvaxia may be connected to three deaths in the Philippines. No direct causal link was established, but immunizations have dropped off sharply.
The Philippine Health Ministry has said in a statement that its inquiry into the deaths of 14 children injected with Dengvaxia — the world's first dengue vaccine — had found no conclusive proof it had caused any of the fatalities, but that in three cases there was a causal association.
"They died of dengue even [though] they were given Dengvaxia. Two of them may have died because of vaccine failure," Health Undersecretary Enrique Domingo told a news conference.
Nine others died of reasons unrelated to dengue, while the cause of two other deaths could not be determined, he said.
The Health Ministry halted Dengvaxia immunizations in November and set up a 10-member panel of experts to determine if the drug had been directly connected to the deaths of the 14 children after they were given the vaccine.
"These findings strengthen the decision of the Department of Health to stop the vaccine. It has failed in some children," Domingo said.
"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," he said.
The 14 children were among the 830,000 who got the vaccine as part of the world's first public dengue immunization program in 2016 and 2017.
The dengue death rate in the Philippines is 60 times higher than the global rate, with 732 deaths last year.
Panic reducing willingness to immunize
After the drugmaker's French company Sanofi said in November that Dengvaxia could increase the risk of severe disease in people who had never been exposed to the dengue virus, some parents alleged the vaccine had caused the deaths of their children. Their accounts seem to have caused panic among parents across the country:
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Immunization rates for polio, chicken pox, tetanus and other diseases had significantly dropped from previous years since November, Domingo said.
On Saturday, Sanofi said the inquiry's findings had confirmed that there is currently no evidence directly linking the Dengvaxia vaccine to any of the 14 deaths. The Philippines has already fined Sanofi a symbolic $2,000 (€1,650), citing violations in product registration and marketing.
"We sympathise with all the families who have suffered the loss of a child. Sanofi Pasteur's mission is to reduce or eliminate suffering for millions around the world through vaccination, including in the Philippines," a spokesman for Sanofi meanwhile said in an emailed statement.
"Dengue fever is one of the most pressing public health issues facing the Philippines today. Sanofi Pasteur remains committed to working with the Philippines government and all organisations to address this urgent public health challenge."
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.
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.