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

6 U.S. territories and freely associated states.
DengvaxiaTM 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 Nov

2022 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Unpublished data presented by Takeda to ACIP and ASTMH *57 months after first dose, significant results bolded.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, significant 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 Representatives

Elizabeth Barnett (AAP)

Rob Schechter (AIM)

Consultants

Edwin Asturias

Robert Atmar

Alan Barrett

Iris Cardona

Anna Durbin

Tony Marfin

Kristen Pierce

Anita Shet

CDC Contributors

Josh Wong

Mimi Eckert

Rachel Eidex

Alfonso Hernandez

Susan Hills

Terri Hyde

Mike McNeil

Jorge Munoz

Erin Staples

Cindy Weinbaum

Rita Helfand