Fostering regulatory collaboration to improve access to mpox medicines
October 25, 2024
International regulators have published findings from an EMA-organized workshop addressing mpox vaccine and therapeutic development. Following WHO's August 2024 emergency declaration due to the surge of clade I strain cases in Africa, regulators discussed vaccine availability, evidence gaps in vulnerable populations, surveillance systems, and approval pathways. The October 2 virtual workshop, moderated by leaders from NAFDAC and EMA, emphasized the need for large clinical trials and coordinated approaches. Participants stressed that medicine availability remains a major challenge in controlling outbreaks.
The International Coalition of Medicines Regulatory Authorities (ICMRA) has released a report detailing outcomes from a crucial workshop on mpox vaccine and therapeutic development. The meeting comes amid growing concerns about the evolution and spread of the virus, particularly in Africa.
Key Workshop Points:
1. Context and Timing:
- Held virtually on October 2, 2024
- Followed WHO's August 2024 public health emergency declaration
- Focused on medicine access in most affected countries
- Built on previous ICMRA regulatory workshop experiences
2. Current Situation:
- Surge in cases in Democratic Republic of Congo and neighboring countries
- Evolution of mpox clade I strain into new sub-clade Ib
- Similar pattern to clade II strain from 2022/2023 emergency
- Limited medicine availability remains a major challenge
3. Key Discussion Areas:
- Current epidemiological status
- Vaccine availability in African countries
- Evidence gaps for vulnerable populations (children and pregnant women)
- Surveillance system establishment
- Regulatory pathways for new treatments
4. Recommendations and Conclusions:
- Need for large clinical trials to generate robust evidence
- Emphasis on coordinated international approach
- Focus on faster development and approval processes
- Importance of international collaboration and information sharing
5. Leadership:
- Moderated by Moji Adeyeye (NAFDAC Director General)
- Co-moderated by Marco Cavaleri (EMA Head of Public Health Threats)
- Included international regulatory authorities and WHO experts
The workshop represents a significant step toward improving global response to mpox outbreaks through enhanced regulatory cooperation and streamlined development processes for vaccines and treatments.