2016-03-09-世界卫生组织-WHO_global_consultation_of_research_related_to_Zika_virus_infection_48页_827kb

WHO Global Consultation on Research Related to Zika Virus Infection (7–9 March 2016)

Core Content

The World Health Organization (WHO) convened a global consultation in Geneva on 7–9 March 2016 to address the urgent research and development (R&D) needs related to the Zika virus outbreak. This event was part of the WHO R&D Blueprint initiative, which aims to improve preparedness for emerging pathogens. The consultation brought together experts from various fields, including virology, clinical medicine, public health, and regulatory affairs, to accelerate the development and evaluation of medical countermeasures.

The meeting focused on four main areas: vaccines, in vitro diagnostics (IVDs), vector control, and therapeutics. It also emphasized the importance of data sharing and international collaboration to ensure timely and effective responses.

Main Points

1. Zika Virus Overview and Global Concerns

• The meeting reviewed the current understanding of flaviviruses, including their origins, spread, classifications, and symptoms.
• Zika virus was identified as a serious public health threat, with potential links to microcephaly and Guillain-Barré syndrome (GBS).
• The 2013/14 French Polynesian outbreak showed a 24 per 100,000 incidence of GBS, which was compared to the situation in Brazil, where the link between Zika and microcephaly was being investigated.

2. Research and Development Response

• WHO initiated an emergency R&D response plan to address the need for vector control, IVDs, vaccines, and therapeutics.
• The consultation aimed to identify knowledge gaps, develop target product profiles (TPPs), and coordinate international efforts.

3. Vaccine Development

• Vaccine development is critical for future outbreaks, though it may be too late for current affected countries.
• A draft TPP for an emergency use vaccine was presented, with public consultation planned for soon, and a final TPP expected by May 2016.
• Challenges include the lack of reliable animal models, reference reagents, and assays for Zika vaccine development.

4. In Vitro Diagnostics (IVDs)

• IVD development is active, with manufacturers proposing various products.
• A TPP for multiplex IVDs was developed to enable differential diagnosis of Dengue, Chikungunya, and Zika.
• The EUAL procedure was highlighted as a mechanism to expedite the approval of diagnostic tools during emergencies.
• Standardization and access to reference materials were emphasized to support product development.

5. Vector Control

• Entomological investigations are essential to understand the transmission dynamics of Zika.
• Classical vector control interventions have not been shown to significantly reduce Dengue transmission, highlighting the need for improved implementation and community engagement.
• New tools such as genetically modified mosquitoes and vector competence studies were discussed, with a WHO advisory meeting planned to explore these further.

6. Therapeutics

• Research into therapeutic options is ongoing, with a focus on understanding the infection stages and Zika biology.
• Antivirals and immune-based interventions are being evaluated, and repurposing existing molecules for Zika treatment is being considered.
• Animal models are needed to better understand pathogenicity and reproductive toxicity of potential treatments.

7. Regulation and Data Sharing

• Regulators expressed support for innovation and accelerated product development.
• Data sharing was identified as a critical component of the response, with a call for transparent and systematic methods.
• WHO and major journals supported pre-publication data sharing, and the WHO Bulletin is facilitating this.
• International collaboration was emphasized, with agencies like ANVISA, EMA, and FDA committing to expedited evaluations.
• Material transfer agreements (MTAs) and bio-banking were discussed as tools to enhance research and development.

Key Information

• The consultation was part of the WHO R&D Blueprint, which was initiated in response to the 2014/15 Ebola outbreak.
• Microcephaly and GBS were central topics, with causality frameworks and pathogenesis studies being prioritized.
• Data sharing is crucial for improving understanding and developing effective interventions, especially in the context of sample banking and standardized protocols.
• International standards for NAT assays are being developed, with NIBSC and Paul Ehrlich Institute leading the effort.
• Collaborative efforts are ongoing to develop SOPs for vector competence studies and to improve diagnostic accuracy.

Conclusion

The WHO consultation was a pivotal step in accelerating R&D for Zika virus-related products. It underscored the need for international collaboration, standardization, and data transparency. The development of TPPs, EUAL procedures, and new vector control tools was identified as essential to address the current and future threats posed by the Zika virus. The meeting also highlighted the importance of long-term strategies for maternal and child health and prenatal care, beyond immediate emergency responses.