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Phase 3 Trials of Its First Indigenous Dengue Vaccine

Phase 3 Trials of Its First Indigenous Dengue Vaccine

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Context:
  • With assistance from ICMR, Panacea Biotec has developed India’s first domestic dengue vaccine, and more than 8,000 people have signed up for Phase 3 trials.
  • What Is the First Dengue Vaccine in India?
    • DengiAll is a tetravalent dengue vaccine that offers protection against all four serotypes of the dengue virus (DENV-1 to DENV-4).
    • Origin: Based on the TV003/TV005 strain that was first created by the National Institutes of Health (NIH) in the United States and licensed to Indian companies.
    • The Indian Council of Medical Research (ICMR) is the main sponsor and scientific leader of the project.
    • Leading formulation trials and possessing process patents, Panacea Biotec is a vaccine developer.
  • How Does It Operate?
    • Nature of tetravalents: lowers the risk of reinfection by providing immunity against all four dengue strains.
    • Weakened viruses are introduced by live-attenuated viruses to safely elicit an immune reaction.
    • Two-dose vaccination: After receiving doses, participants undergo a two-year medical follow-up to evaluate the vaccine’s effectiveness.
  • Important attributes:
    • All of India Coverage: Twenty locations, including Chennai, Pune, Delhi, and Hyderabad, are hosting trials.
    • Large-scale Participation: Of the 10,000 targeted candidates, nearly 80% of them completed the enrolment process.
    • Process Patented: Panacea is the owner of the exclusive rights to the vaccine’s creation.
    • Prior Trial Success: Phases 1 and 2 were finished in 2018–19 with positive outcomes.
    • Clinical Vigilance: After vaccination, participants will be observed for two years.
  • Importance to India:
    • Impact on Public Health: Deals with one of the most common diseases spread by mosquitoes in India.
    • Child Health Focus: Provides vital protection for kids, who are more likely to need hospitalisation.
    • Because there is little cross-protection between dengue serotypes, it is essential to reduce recurrent infections.