Philippine health officials have ordered Sanofi to jerk its dengue vaccine off the market as the controversy over the health threat it poses to children continues to roil the country.
The Philippines was the first country to launch a major vaccination campaign with Dengvaxia, the world’s first dengue vaccine. But last week Sanofi conceded something that two expert groups had concluded independently just as the country was rolling out its $70 million effort early last year. The vaccine, given to anyone who had not already been infected, left people vulnerable to severe, life-threatening dengue in the event they were subsequently infected by wild type dengue.
Both independent studies in Vaccine and Science concluded that Sanofi’s own trial data on severe infections among 2-to-5 year olds offered ample warning of the health threat Sanofi finally conceded.
Health officials say they vaccinated 730,000 children in the Philippines, 9 and up.
Sanofi’s health warning last week suggested only that the vaccine label be changed to urge health officials to determine the likelihood that someone had been previously infected before vaccinating them.
Sanofi officials have downplayed the threat, saying only a small fraction of the children vaccinated face the threat of hemorrhagic fever. This is also a vaccine intended for millions of people around the world, and the safety bar is typically set high.
Brazilian officials, meanwhile, say that they’ve restricted the use of the vaccine in the wake of the disclosure by Sanofi. And the EMA, which has the vaccine under review now, tells me that regulators will take into account “any emerging data” in completing its assessment.
Sanofi spent $1.8 billion over more than 20 years to prep this launch, expecting to develop a new franchise worth $1.5 billion a year. But noted dengue expert Scott Halstead — who has spent decades in the field — says that Sanofi’s researchers never fully learned the biology of the disease they were trying to eradicate, pointing them straight to the crisis they’re in now.
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