Is the Qdenga (Dengue vaccine) safe for a 3-year-old child?

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Seguridad de la Vacuna Qdenga en Niños de 3 Años

La vacuna Qdenga NO está aprobada ni recomendada para niños de 3 años de edad, ya que la edad mínima aprobada es de 4 años. 1

Edad Mínima Aprobada

  • La Agencia Europea de Medicamentos (EMA) aprobó Qdenga únicamente para personas mayores de 4 años de edad. 1
  • Los estudios clínicos de eficacia y seguridad de TAK-003 (Qdenga) se realizaron en participantes de 4 a 16 años viviendo en áreas endémicas de dengue. 2
  • No existen datos de seguridad ni eficacia para niños menores de 4 años. 2, 1

Evidencia de Eficacia por Grupo de Edad

Los datos disponibles muestran que incluso en el grupo de edad más cercano (4-5 años), la eficacia es considerablemente menor que en niños mayores:

  • Niños de 4-5 años: Eficacia del 43.5% (IC 95%: 25.3%-57.3%) contra dengue confirmado virológicamente. 2
  • Niños de 6-11 años: Eficacia del 63.5% (IC 95%: 56.9%-69.1%). 2
  • Adolescentes de 12-16 años: Eficacia del 67.7% (IC 95%: 57.8%-75.2%). 2

Consideraciones de Seguridad Específicas

Existe evidencia de riesgo potencial de enfermedad aumentada por la vacuna (disease enhancement) en receptores seronegativos, especialmente en niños menores de 6 años para los serotipos 3 y 4 del dengue. 3

  • Este riesgo es particularmente preocupante en niños pequeños que no han tenido infección previa por dengue. 3
  • La eficacia protectora contra el serotipo DENV-3 es limitada en individuos seronegativos. 4

Recomendación Práctica

Para un niño de 3 años:

  • Debe esperar hasta cumplir al menos 4 años de edad para considerar la vacunación con Qdenga. 1
  • La vacunación debe realizarse solo si el niño vive en áreas de transmisión moderada a alta de dengue (seroprevalencia >60% en niños de 9 años). 3
  • Se debe evaluar el estado serológico previo antes de la vacunación, aunque esto es más crítico para la vacuna Dengvaxia que para Qdenga. 5

Advertencia Importante sobre Viajes

La vacuna contra dengue NO debe administrarse a niños que viajan o visitan áreas endémicas de dengue de manera temporal. 6

  • Las medidas de protección personal (aire acondicionado, mosquiteros, repelentes) son la estrategia principal para viajeros. 7
  • La vacuna está diseñada para residentes permanentes en zonas endémicas, no para viajeros. 6, 1

References

2
Research

Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025

5
Research

Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021.

MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports, 2021

6
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

7
Guideline

Chikungunya Vaccine Timing for Travel

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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