Date: Tuesday 2 August, 2022
Time: 13:00 to 18:00 CET
The WHO R&D Blueprint organized a consultation to discuss knowledge gaps and priority research questions for mpox (monkeypox) vaccine research.
OBJECTIVES
The Director-General of WHO decided that the global monkeypox outbreak represents a public health emergency of international concern. [Source: WHO Director-General's press statement]
WHO is recommending that Member States make all efforts to use existing or new vaccines against mpox within a framework of collaborative clinical efficacy studies, using standardized design methods and data collection tools for clinical and outcome data, to rapidly increase evidence generation on efficacy and safety, collect data on effectiveness of vaccines (e.g., such as comparison of one or two dose vaccine regimens), and conduct vaccine effectiveness studies. [Source:Second meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country outbreak of monkeypox]
To facilitate the implementation of the above recommendations, the WHO R&D Blueprint for epidemics organized a global consultation to discuss mpox vaccine research.
What study designs can be used to address the remaining knowledge gaps for mpox vaccines?
During this forthcoming consultation global experts reviewed the available evidence in terms of:
- Overview of potential study designs.
- Plans to evaluate vaccine efficacy/effectiveness of mpox vaccines in different countries.
- Optimal strategies for the design of randomised and non- randomised studies for vaccine efficacy and effectiveness.
EXPECTED OUTCOMES
- Consensus critical attributes of optimal study designs
- Outline of the next steps to share information on plans to evaluate and on emerging results
PRESENTATIONS
- Currently available evidence on monkeypox vaccines
- What are the priority knowledge gaps regarding monkeypox vaccines?
Session 1. Randomized Evidence
- Pour une évaluation des vaccins anti-variole du singe en RD Congo
- MVA-BN dose sparing
- Randomisation during deployment of monkeypox vaccination
Session 2. Non-Randomized Evidence
- Current strategies for vaccine deployment and their implications for the design of observational studies
- Challenges and successes in estimating vaccine effectiveness from observational data
- Designing case control studies - Potential strategies to address issues related to bias and confounding
- Assessment of the effectiveness of modified vaccinia Ankara (MVA-BN) (Imvanex) against monkeypox in England
- 2022 Monkeypox Outbreak – Canada Research Perspective
- Monkeypox Vaccine Study Designs – Current situation in Spain
- Monkeypox Vaccine Study Designs - France
- Opportunities for Monkeypox Vaccine Effectiveness Studies – United States
- A single-arm study to evaluate the immunogenicity and safety of smallpox vaccine as vaccination to monkeypox in Japanese healthy adults (MKP-3 study)
- Safety and Effectiveness of MVA-BN vaccination against MPXV infection in at-risk individuals in Germany (SEMVAc)
- WHO Clinical Platform for Monkeypox
- Observational studies registry and sharing protocols – why is that important?
RECORDING