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June 26 – ACIP Meeting
Dengvaxia®Next Steps
Nicholas Bergren PhD, MBA
Director, Scientific and Medical Affairs
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22021 ACIP Recommendation for Dengvaxia®:
ACIP recommends vaccination with the Dengvaxia® vaccine for children aged 9–16 years
having evidence of a previous dengue infection and living in areas where dengue is endemic .
Dengvaxia® is recommended as a 3-dose vaccination series, administered 6 months apart (at
month 0, 6, and 12)for the selected pediatric population . Evidence of previous dengue
infection, such as confirmation with previous laboratory -confirmed infection or a highly
specific serodiagnostic test, will be required among eligible children before vaccination .Dengvaxia® Indication, Schedule & Recommendation
USPI Indication :
For the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
Dengvaxia® is approved for use in individuals 6 through 16 years of age with laboratory -
confirmed previous dengue infection and living in endemic areas .
USPI Dosage and Administration :
Three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12).
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3Dengvaxia® has been available globally since 2015 and was recommended by ACIP in 2021:
▪Efforts have been made to facilitate implementation of the ‘Screen & Vaccinate’ approach as recommended by
WHO in 2018, however demand for Dengvaxia®has been andcontinues to remain low globally and in Puerto Rico.
▪Despite an increased incidence of dengue in different parts of the world, Puerto Rico's Dengvaxia®Immunization
Program is the only public program currently in place.
▪Dengvaxia®is indicated for people with prior dengue infection and requires a 1 -year vaccination schedule to
complete the primary series.
▪Dengvaxia®is not intended for acute dengue outbreak control.Dengvaxia®Next Steps
Dengue Tetravalent Vaccine (Live, Attenuated) [Dengvaxia®] is being discontinued due to low demand.
This decision is not due to any concerns regarding quality, safety or efficacy.
We have worked early with and continue to collaborate with the CDC to facilitate product utilization.
Dengvaxia® will continue to be distributed through public (e.g., VFC) and private markets globally (including
Puerto Rico where it is currently recommended by the ACIP) through product expiry.
The last doses of Dengvaxia®will expire at the end of August 2026. Given the 3-dose, 1 -year series needed for
full immunization, individuals should start the Dengvaxia® immunization series no later than August 31, 2025.
Thank you