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Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases
Updates on Dengue Vaccines
Wilbur Chen, MD
October 26, 2023
Dengue is endemic in
6U.S. territories and freely associated states.
Dengvaxia ™ACIP Recommendation June 2021
Three doses of Dengvaxia are
indicated for the prevention of
dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in people 9–16 years old with:
•laboratory confirmation of
previous dengue virus infection
AND
•living in endemic areas.
Takeda Dengue Vaccine (TAK -003) has been under
review by the FDA since Nov 2022
Dengue Workgroup presented to ACIP 3 times
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov2022 2023
•Takeda dengue
vaccine safety and efficacy presentation
•Workgroup summary and interpretation•Policy questions
•Cost -effective (CE) analysis
(CDC/Notre Dame)
•Comparison of CE models
•Partial EtR•Dengue epidemiology
•Review of Sanofi dengue vaccine and ACIP recommendation•Plan to present draft recommendations
Overall VE
61.2% (56.0, 65.8%)
VE in Seropositives
64.2% (58.4, 69.2%)VE in Seronegatives
53.5% (41.6– 62.9%)
VE in Seropositives by Serotype
DENV -1 56.1% (44.6, 65.2%)
DENV -2 80.4% (73.1, 85.7%)
DENV -3 52.3% (36.7, 64.0%)
DENV -4 70.6% (39.9, 85.6%)VE in Seronegatives by Serotype
DENV -1 45.4% (26.1, 59.7%)
DENV -2 88.1% (78.6, 93.3%)
DENV -3 -15.5% (-108.2, 35.9%)
DENV -4 -105.6% (-628.7, 42.0%)TAK-003 Efficacy* Outcome: Virologically Confirmed Dengue
Unpublished data presented by Takeda to ACIP and ASTMH*57 months after first dose, s ignificant results bolded. Number for seropositive placebo
participants 4,855 and vaccine 9,666; Seronegative placebo 1,832 and vaccine 3,714.
Overall VE
84.1% (77.8, 88.6%)
VE in Seropositives
85.9% (78.7, 90.7%)VE in Seronegatives
79.3% (63.5, 88.2%)
VE in Seropositives by Serotype
DENV -1 66.8% (37.4, 82.3%)
DENV -2 95.8% (89.6, 98.3%)
DENV -3 74.0% (38.6, 89.0%)
DENV -4 100% (NE, NE)†VE in Seronegatives by Serotype
DENV -1 78.4% (43.9, 91.7%)
DENV -2 100% (NE, NE)§
DENV -3 -87.9% (-573.4, 47.6%)¶
DENV -4 100 % (NE, NE)**TAK-003 Efficacy* Outcome: Hospitalization
†DENV -4 Placebo events: 3 TAK-003 events: 0§DENV -2 Placebo events: 23 TAK -003 events: 0
¶DENV -3 Placebo events: 3 TAK-003 events: 11
**DENV -4 Placebo events: 1 TAK-003 events: 0
*57 months after first dose, s ignificant results bolded. Number for seropositive placebo
participants 4,855 and vaccine 9,666; Seronegative placebo 1,832 and vaccine 3,714. Unpublished data presented by Takeda to ACIP and ASTMH
European Medicines Agency (EMA) Committee for
Medicinal Products for Human Use (CHMP) issued positive opinion for TAK- 003
October 2023
•EU-M4all: parallel review for EU and participating dengue endemic
countries globally
•TAK-003 vaccine approved in multiple countries
‒EU, UK, Brazil, Argentina, Indonesia, & Thailand
On July 11, Takeda voluntarily withdrew
TAK-003 from FDA review.
https://www.takeda.com/newsroom/statements/2023/takeda -announces -voluntary -withdrawal -of-US-biologics -license -application -for-dengue -vaccine -candidate -TAK-003/
WHO SAGE Recommendations for TAK -003
Sept 25, 2023
•Consider for introduction in settings with high dengue disease burden and
high transmission intensity
•SAGE recommended the vaccine be introduced to children aged 6 to 16
years of age.
‒Within that age range, the vaccine should be introduced about 1-2 years prior to
the age -specific peak incidence of dengue- related hospitalizations.
‒The vaccine should be administered in a 2 -dose schedule with a 3 -month interval
between doses.
Future Dengue Vaccine Work
•Dengue workgroup will be paused until TAK -003 is re -submitted to FDA or a
new vaccine submitted for approval
ACIP Dengue Vaccines Workgroup
ACIP Members
Wilbur Chen (Chair)
Kathy Poehling
Beth Bell
Veronica McNally
CDC Co- Lead
Gabriela Paz -Bailey
Laura Adams
Ex Officio Members
Kaitlyn Morabito (NIH)
Ralph LeBlanc (FDA)
Ihid Carneiro Leao (FDA)
Kirk Prutzman (FDA)
Srihari Seshadri (DOD)Liaison RepresentativesElizabeth Barnett (AAP)
Rob Schechter (AIM)
Consultants
Edwin Asturias
Robert Atmar
Alan Barrett
Iris Cardona
Anna Durbin
Tony Marfin
Kristen Pierce
Anita ShetCDC Contributors
Josh Wong
Mimi Eckert
Rachel Eidex
Alfonso Hernandez
Susan HillsTerri Hyde
Mike McNeil
Jorge Munoz
Erin Staples
Cindy Weinbaum
Rita Helfand