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AA ACC CII IPP PDD Dee enn ngg guu uee eVV Vaa acc ccc cii inn nee e
WW Woo orr rkk kgg grr roo ouu upp pACIP Dengue Vaccine
Workgroup
Wilbur Chen, MD, MSc
ACIP Member and Workgroup Chair
Advisory Committee on Immunization Practices
ACIP Meeting February 23, 2023
Dengue Virus
DENV-1, 2, 3, 4
• Lifelong DENV type-specific
immunity
• Short-term cross-immunity (~1–2 years)
• A second dengue infection is the most important risk factor for severe dengue
Dengue is the most common
mosquito-borne virus globally
Dengvaxia™
an d previou s
dengue
infection Clinical trials found different outcomes after
Dengvaxia™ vaccination among children with and
without previous dengue infection.
• Children without previous dengue infection had a
higher risk hospitalization and severe dengue if they
were vaccinated and then had a DENV infection.
• Children with previous dengue infection were
protected from hospitalization and severe dengue if
they were vaccinated with Dengvaxia™.
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.
Work group timeline 2023 for TAK003
Presentations to ACIP
Feb March April May June July Aug Sept Oct Nov
Vaccine efficacy, immunogenicity, and
safety data and WG Interpretation GRADE analysis and cost -
effectiveness analysis EtR, draft recommendations,
and ACIP vote
Summary of work group plans and activities
• Review of efficacy, immunogenicity, and safety data (GRADE)
• Review of EtR domains and cost-effectiveness analysis
• Presentation of policy options and ACIP vote
Presentations today
TAK-003 Efficacy, Safety and Immunogenicity Data
Dr. Shibadas Biswal, Takeda
Work Group Summary and Interpretation of TAK-
003 Efficacy, Safety, and Immunogenicity Data
Dr. Gabriela Paz-Bailey, CDC, NCEZID, DVBD
AA ACC CII IPP PDD Dee enn ngg guu uee eVV Vaa acc ccc cii inn nee ess sWW Woo orr rkk kgg grr roo ouu upp p 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