FDA Approves First Vaccine for Dengue, With Restrictions.

[Argirios Argiriou]

May 02, 2019

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Dengvaxia is not approved for people not previously infected by any dengue virus serotype or for patients whose status regarding previous infection is unknown. "This is because in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection — without actually infecting the person with wild-type dengue virus — such that a subsequent infection can result in severe dengue disease," the FDA says.

Therefore, the FDA advises healthcare professionals to evaluate individuals for prior dengue infection to avoid vaccinating persons who have not been previously infected by dengue virus. Confirmation of previous infection can be established through a medical record of the patient's having previously had a laboratory-confirmed dengue infection or through serologic testing prior to vaccination.

It is estimated that one third of the world's population live in areas at risk for infection by dengue virus. Each year, an estimated 400 million dengue virus infections occur globally, according to the US Centers for Disease Control and Prevention. Of these, roughly 500,000 cases develop into DHF, which contributes to about 20,000 deaths, primarily among children

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