Global Regulators Unite to Address Mpox Treatment Access and Research Gaps
Key Insights
International regulators, including the EMA and FDA, convened to address unequal access to mpox (search) treatments, particularly in low-income African countries.
Discussions focused on expanding mpox (search) vaccine use to vulnerable populations like pregnant women and children, emphasizing the need for more clinical evidence.
Collaborative efforts are urged to streamline clinical research and regulatory pathways for mpox (search) vaccines and drugs, avoiding fragmented studies.
An international coalition of medicine regulatory authorities, including the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), convened to address critical gaps in access to mpox (search) treatments and vaccines, particularly in low-income countries. The virtual workshop, held on October 2, 2024, under the International Coalition of Medicines Regulatory Authorities (ICMRA), highlighted the urgent need for collaborative strategies to combat the global mpox outbreak.
A key focus of the meeting was the disproportionate availability of medical interventions, such as antivirals and vaccines, with African countries facing the greatest challenges. "One of the major challenges during these outbreaks has been the unequal availability of medical interventions... with low-income countries in Africa facing the greatest difficulties," the ICMRA report stated. High-income countries had more ready access to vaccines, while African nations, where mpox (search) is endemic, struggled with delayed regulatory approvals and inaccessible prices.
Addressing Vulnerable Populations
The discussion prioritized treatments for pediatric populations, as children in the Democratic Republic of Congo are the most vulnerable group with the highest fatality ratio. While the FDA has granted emergency use authorization for the MVA-BN vaccine (search) in children and Canada has authorized it for individuals 18 or older with discretionary use in children, the EMA has expanded its indication for children aged 12 to 17. The report acknowledged limited evidence for MVA-BN vaccine use in children under 12 but noted that the safety profile is not expected to differ. The WHO Strategic Advisory Group of Experts on Immunization has also recommended MVA-BN vaccine use in children if benefits outweigh risks.
Overcoming Vaccine Supply Gaps
To address vaccine supply gaps, the workshop recommended considering a dose-sparing strategy using intradermal administration. Participants also suggested exploring the use of LC16m8, a vaccine currently approved for all age groups in Japan, as an alternative.
Streamlining Regulatory Pathways and Clinical Research
The workshop participants addressed the need to consider alternative regulatory pathways for new vaccine development, moving beyond traditional placebo-controlled studies and exploring alternative administration methods. "ICMRA unanimously agreed that fragmentation in clinical research... must be avoided, as studies need to be conducted rapidly and efficiently in the best interest of patients," the report emphasized. The regulators advocated for greater collaboration to merge investigator efforts into larger, unified clinical trials.
The collaborative effort aims to ensure equitable access to mpox (search) treatments and vaccines, particularly for vulnerable populations and in regions where the disease is endemic. By streamlining regulatory pathways and fostering international cooperation, the ICMRA seeks to improve the global response to future outbreaks.