With its dengue vaccine in the regulatory queue, Takeda outlines longterm followup data that it says keep it out of Dengvaxia's shadow
When Sanofi published longterm followup results from a trio of Phase III trials for its dengue vaccine in 2015, investigators flagged a concerning observation that they weren’t able to explain: In the third year post-vaccination, children younger than 9 who got the jabs were more likely to end up in the hospital than those in the control group.
The hospitalization imbalance didn’t stop Sanofi from clinching the approval to start the world’s first large-scale vaccination campaign in the Philippines with its vaccine, Dengvaxia. But even though public health officials tried to skirt it by limiting the inoculation drive to older children and adults, the issue — which Sanofi was later accused of playing down — would come back to haunt the effort. Kids and adults were developed with severe fever after vaccines, in some cases lethal, sparking nationwide panic and forcing the Phillippine government to shut down the program. Even though Dengvaxia eventually got adopted in other countries, the fiasco left its scars.
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