2016-03-02-世界卫生组织-Current_Zika_Product_Pipeline_16页_488kb

Current Zika Product Pipeline (3 March 2016)

Introduction

• WHO initiated an emergency R&D plan for Zika to address the outbreak, aligning with the WHO R&D Blueprint.
• Key priorities: diagnostics, vaccines, therapeutics, and vector control tools for Zika.

Diagnostic Development

• Over 30 diagnostic tests (PCR, ELISA, RDTs) are under development.
• Regulatory hurdles for rapid deployment exist; WHO is prioritizing needs and creating target product profiles.
• WHO-EUAL Procedure provides standardized quality assessment for diagnostics.

Anti-virals & Therapeutics

• Therapeutic roles uncertain due to limited understanding of Zika infection.
• Existing antivirals (e.g., ribavirin) are under investigation but lack proven efficacy vs. risks in pregnancy.
• Prophylaxis (e.g., small-molecule drugs) and monoclonal antibodies are potential options, but long-term safety and administration ease are critical.

Vaccine Development

• 18 active vaccine projects underway (academic and commercial entities).
• Early preclinical stages; Phase 1 trials expected by end-2016.
• Approaches include inactivated virus, nucleic acid vaccines, live vectors, subunits, and VLPs.
• WHO is developing a target product profile for vaccines prioritizing pregnant women.

Vector Control Methods

• Mechanical: Ovitraps are being improved for efficacy.
• Chemical: Development of new insecticides and delivery mechanisms.
• Biological: Proven methods include releasing Bacillus thuringiensis israelensis (Bti) and using Wolbachia-infected mosquitoes.
• Genetic: Sterile Insect Technique (SIT), Release of Insects with Dominant Lethal (RIDL), gene drives, and RNAi-mediated sterility are under development or testing.

Product Pipelines

• Diagnostic Pipeline: Early to mid-stage development includes PCR, ELISA, and RDTs; some receive regulatory approval.
• Therapeutics: Antivirals and monoclonal antibodies are considered, but safety in pregnancy is key.
• Vaccines: Diverse technologies in preclinical/early clinical stages.
• Vector Control: New tools aim to improve current vector management strategies.