Updated
September 28th, 2019

Dengue Vaccine One Step Closer to FDA Approval

Dengvaxia dengue vaccine received positive FDA committee recommendation

kid diving into water

The Food and Drug Administration (FDA) vaccine advisory committee recommended approving Dengvaxia, a dengue virus vaccine, for people between the age of 9 to 16 years old. 

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted favorably on the safety (10 to 4) and effectiveness (13 to 1) of Dengvaxia for the prevention of dengue disease caused by serotypes 1 – 4 of the virus, in persons living in endemic areas that experienced a laboratory-confirmed previous dengue infection. 

The FDA is expected to issue its ruling on the VRBPAC committee’s recommendation by May 1, 2019. 

This FDA recommendation is good news since the dengue virus is endemic in Puerto Rico, the US Virgin Islands, and the US-affiliated Pacific Islands. 

And, US states such as Florida have reported locally transmitted dengue cases during 2018.   

Moreover, half of the world's population living in 100+ countries is at risk of the dengue virus. 

But, Americans do not have access to a dengue vaccine today. 

Previously, on December 19th, 2018, the European Commission (EC) granted marketing authorization to Sanofi Pasturer for Dengvaxia use in dengue virus endemic areas in Europe. 

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The EC approved Dengvaxia for individuals between 9-45 years of age, and most importantly, with a documented prior dengue infection. 

People can get dengue up to 4 times, and a dengue virus 2nd infection could be worse than the first. 

Dengue infection can progress unpredictably into a life-threatening form of the disease called dengue hemorrhagic fever, says the US Centers for Disease Control and Prevention (CDC). 

The CDC says data are limited on the health outcomes of dengue during pregnancy and effects of maternal infection on the developing fetus. 

The CDC has issued various travel alerts related to dengue and updated its ‘maps’ on February 13, 2019.

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