Which dengue vaccine is currently approved and available for use in India?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: October 25, 2026 • View editorial policy

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.

Dengue Vaccines Available in India

Currently, no dengue vaccine is officially approved and available for routine use in India. While several dengue vaccines exist globally, India has not yet licensed any for commercial distribution in its market.

Global Dengue Vaccine Landscape

Three main dengue vaccines have been developed and approved in various countries:

1. Dengvaxia® (CYD-TDV)

  • FDA-approved and licensed in multiple countries since 2015
  • Not approved in India
  • Overall vaccine efficacy of 60% 1
  • Restricted use: only for individuals aged 6-16 years with laboratory-confirmed previous dengue infection 2
  • Carries risk of antibody-dependent enhancement (ADE) in dengue-naïve individuals, particularly children under 9 years 1, 3

2. Qdenga® (TAK-003)

  • Approved in European Union, United Kingdom, Brazil, Argentina, Indonesia, and Thailand 2
  • Not approved in India
  • Overall vaccine efficacy of 80% after 12 months 1
  • Demonstrated 85% reduction in hospitalized dengue cases 4
  • Limitation: does not provide protective effect against DENV-3 in dengue-naïve individuals 1
  • Produces sustained antibody responses against all four serotypes regardless of previous exposure 2

3. Butantan-DV

  • Still undergoing Phase 3 clinical trials 1
  • Not approved anywhere, including India

Indian Vaccine Development Efforts

India has been conducting clinical trials for a tetravalent live attenuated dengue vaccine:

  • Serum Institute of India manufactured a tetravalent live attenuated dengue vaccine after receiving vaccine strains from NIAID, NIH, USA 5
  • Phase 1 trial completed in 60 healthy Indian adults (2023) 5
  • Showed promising results:
    • Safe and well-tolerated
    • Highly immunogenic with 79.5-100% seroconversion rates across serotypes
    • GMTs ranged from 66.76 to 293.84 for all four serotypes by day 57 5
  • Status: Still in early clinical development, not yet approved for public use

Clinical Implications

For patients in India requiring dengue prevention:

  • No licensed vaccine option currently exists
  • Prevention relies entirely on vector control and personal protective measures
  • Travelers from India to countries where Qdenga® is approved could potentially receive vaccination abroad, though this requires individual country regulations review
  • Monitor for future approval of the Serum Institute vaccine, which showed promising Phase 1 results in Indian adults 5

Important Caveats

All live-attenuated dengue vaccines carry contraindications for:

  • Immunocompromised individuals
  • Pregnant women 3
  • Individuals without confirmed prior dengue infection (for Dengvaxia®) due to ADE risk 3

The absence of an approved dengue vaccine in India represents a significant gap given the country's high dengue burden and endemic status, making continued reliance on mosquito control and clinical management essential until vaccine approval occurs.

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.