2016-06-28-世界卫生组织-Real-time_Evaluation_of_Research_and_Development_R_D_Response_to_Zika_15页_443kb

Real-time Evaluation of R&D Response to Zika: Summary

Context

• The evaluation assessed progress towards agreed milestones and answered specific questions regarding WHO's Research and Development (R&D) response to Zika.
• A scoping mission in April 2016 preceded this review, which took place in June 2016.

General Issues

Role and Scope of the Blueprint

• The WHO Blueprint prioritized R&D for Zika, identified as a serious threat requiring urgent action.
• The Blueprint proved valuable, accelerating R&D efforts compared to pre-Ebola approaches.
• The scope of "R&D" is disputed and needs clarification, potentially limiting coordination with related initiatives like GLOPID-R.

Coordination

• Coordination mechanisms for Zika R&D have been more effective than during the Ebola response, but:
  • Information sharing with external stakeholders is not systematic.
  • Activities between WHO departments and with broader Zika response groups require better integration.
• Recommendations include establishing a network of outbreak investigators and clarifying WHO’s communication and coordination roles.

Landscape Analyses

• WHO conducted initial and ongoing landscape analyses for diagnostics, vaccines, vector control, and treatment.
• Challenges include incomplete data from manufacturers and difficulties in sample access/sharing, particularly in Brazil due to national restrictions.

Comparisons to Ebola

• Lessons from Ebola improved Zika response, but differences between diseases limit cross-learning (e.g., no vaccines/treatments existed for Zika vs. some for Ebola).
• EUAL processes were adopted from Ebola and are speeding diagnostic assessments.

Funding and Resources

• Insufficient funding remains a major barrier; only a fraction of the required $4m (first six months) was secured, and less than $1m targeted R&D.
• The UN Zika Multi-Partner Trust Fund (MPTF) aims to address this but has a narrow focus on prevention, not R&D.

Role of WHO

• WHO's comparative advantage is coordination and convening, not direct research.
• Challenges include defining its role clearly in emergency R&D and internal reforms to better manage emergencies.

Detailed R&D Issues

Diagnostics

• EUAL procedures have advanced diagnostics development; however, product performance testing faces constraints (sample access, test reliability concerns due to cross-reactivity).
• Recommendation: Establish a network of laboratories and clear guidelines for performance evaluation.

Vaccines

• A target product profile (TPP) for Zika vaccine was agreed; the vaccine is largely untested in humans.
• Questions remain on efficacy, safety in pregnant women, and ethical considerations.
• Recommendation: Further meetings needed to resolve clinical trial endpoints and priorities.

Vector Control

• New approaches (e.g., Wolbachia, transgenic mosquitoes) are under evaluation, but their effectiveness is uncertain.
• Recommendation: Operational planning for pilot deployment and integrated vector management (IVM) to balance control with reproductive health protection.

Treatment

• Focus has been less on treatments due to the mild nature of most cases.

Conclusions and Recommendations

• Clarify linkages between the Blueprint and broader research agendas.
• Strengthen communications and stakeholder engagement.
• Improve procedural efficiency in emergencies (e.g., ethical reviews, reference materials).
• Secure and dedicate funds specifically to R&D.
• Establish lab networks, biobanks, and specialized R&D staff.
• Conduct further discussions on critical topics like Zika vaccination strategies.

Annex Overview

• Annex 1: Proposed mission timeline and topics.
• Annex 2: Reviewed documents and initiatives.
• Annex 3: Interviewed key informants.
• Annex 4: Status of milestones and answers to questions.