International medicines regulatory authorities are intensifying their collaboration to enhance access to vaccines and therapeutics for mpox, particularly in regions facing significant outbreaks. This initiative follows a workshop organized by the European Medicines Agency (EMA) under the International Coalition of Medicines Regulatory Authorities (ICMRA). The discussions centered on overcoming obstacles in the development, clinical evaluation, and distribution of mpox treatments.
The World Health Organization (WHO) declared mpox a Public Health Emergency of International Concern in August 2024, highlighting the urgency of the situation. The Democratic Republic of Congo and neighboring countries are experiencing a surge in cases driven by the mpox clade I strain, which has evolved into a new sub-clade Ib. A key challenge during these outbreaks has been the limited availability of effective medicines.
Addressing Evidence Gaps and Regulatory Pathways
Participants at the workshop addressed the current epidemiological landscape and the availability of mpox vaccines in African countries. A significant portion of the discussion focused on filling the evidence gap regarding vaccine use in vulnerable populations, such as children and pregnant women. The establishment of effective surveillance systems and the optimization of regulatory pathways for new vaccines and treatments were also key topics.
International regulators emphasized the necessity of conducting large-scale clinical trials to generate the robust evidence required for expedited development and approval of mpox medicines. They also concurred that a more coordinated and collaborative approach would be the most effective strategy for managing current and future public health emergencies.
The workshop, held virtually on October 2, 2024, convened representatives from international medicines regulatory authorities and experts from the WHO. The meeting built upon the knowledge gained from previous ICMRA regulatory workshops, which promoted international collaboration, alignment, and information sharing among regulators worldwide. The discussion was moderated by Moji Adeyeye, Director General of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), and Marco Cavaleri, Head of Public Health Threats at EMA.
