Immunization, Vaccines and Biologicals

Meeting of the WHO advisory committee on dengue and other flavivirus vaccines

15-16 November 2012, Atlanta, USA

The WHO Advisory Committee on Dengue and other Flavivirus vaccines provides technical advice on the preclinical development, clinical evaluation and regulatory research related to new flavivirus vaccines, in particular dengue and Japanese encephalitis. In response to an increasing need for specific advice on complex issues concerning individual flavivirus vaccines, it has been decided to disestablish the committee, and to replace it by more focused technical expert groups or consultations as needed. This was the last meeting the committee was convened in its current format.

The most advanced dengue vaccine candidate is currently in phase 3 trials and, if successful, may be licensed within the next 2-3 years. Several other candidates are at earlier stages of clinical development and have the potential become second generation dengue vaccines with improved product profiles. Once a first dengue vaccine is licensed, requirements for the evaluation and licensure of second-generation vaccines will need to be reassessed

The appropriateness and feasibility of different study designs will depend on the results of ongoing vaccine trials. For example, the establishment of immune correlates of protection in current trials may support the future use of immune-bridging studies to facilitate the evaluation of second generation vaccines.

Objectives of the meeting

The meeting included an open session with invited presentations by dengue vaccine developers, followed by a closed session of the advisory committee.

  • For the open session: Review the pipeline of clinical stage dengue vaccine candidates and discuss possible future regulatory pathways.
  • For the closed session: Review IVR activities related to flavivirus vaccines in the past year; make recommendations to WHO on future research priorities for flavivirus vaccines; discuss ways to continue soliciting technical input and advice from the scientific community.

Expected outcomes

For objective 1:

  • An up to date review of on-going clinical development projects for dengue vaccines; and
  • An assessment of the opportunities and challenges related to future licensure pathways for second generation dengue vaccines, including issues concerning correlates of protection and immune-bridging studies.

For objective 2:

  • Specific recommendations to WHO on future research priorities and activities related to flavivirus vaccines.