The global research community is mobilizing to address the mpox outbreak in Africa, drawing on valuable lessons learned during the COVID-19 pandemic. This strategic approach comes in response to the World Health Organization's (WHO) recent declaration of the African mpox outbreak as a Public Health Emergency of International Concern (PHEIC) in August 2024.
Leveraging Pandemic Experience for Rapid Response
The research landscape is being shaped by three key principles that proved successful during COVID-19 vaccine development: rapid trial initiation, targeted population identification, and adaptive trial design implementation. These approaches are being adapted to address the unique challenges posed by mpox.
Anaelle Tannen, infectious disease analyst at GlobalData, emphasizes the importance of maintaining scientific rigor while accelerating research: "The pandemic re-emphasised the importance of well-designed clinical trials, as well as highlighting the need for transparency and maintaining high standards of scientific integrity."
Streamlined Trial Design and Regulatory Processes
Pharmaceutical companies are implementing real-time data collection methods and adaptive trial designs, allowing researchers to modify protocols efficiently without compromising study integrity. Seth Lederman, co-founder and president of Tonix Pharmaceuticals, notes that these approaches enable faster progression through clinical stages while maintaining safety standards.
The regulatory framework established during COVID-19, including the FDA's Emergency Use Authorizations (EUAs), has created precedents for expedited review processes. This infrastructure is already facilitating faster trial initiations for mpox treatments, as evidenced by recent developments such as Emergent BioSolutions' ACAM2000 receiving expanded FDA approval for adults at high risk of mpox infection.
Challenges in African Implementation
Despite these advances, significant obstacles remain in translating research efforts to affected regions in Africa. Dr. David Schwartz, a medical epidemiologist and infectious disease expert, identifies several key challenges:
- Limited infrastructure in affected areas
- Logistical difficulties in vaccine distribution, particularly for temperature-sensitive products
- Cultural barriers affecting medical decision-making
- Financial constraints
"There are financial problems, issues of manpower, problems in providing access to the affected areas if they are small villages with no proper road networks," explains Schwartz. "If you have a vaccine that requires refrigeration, it's difficult to maintain refrigeration while getting to these areas."
International Collaboration and Resource Allocation
The COVID-19 pandemic established unprecedented levels of global collaboration between private industry, governments, and regulatory bodies. However, the mpox response faces unique challenges in resource mobilization, as the disease primarily affects African nations.
While custom-built facilities for mRNA vaccine manufacturing now exist, thanks to COVID-19 investments, successful implementation will require sustained international support. The WHO has called on governments to increase their commitment to addressing the outbreak, emphasizing the need for coordinated global action.
"An international effort is required with these kinds of viruses," Schwartz emphasizes. "The WHO and other international organisations will be important in implementing these strategies."
As the research community continues to adapt COVID-19 learnings to address the mpox emergency, success will depend on maintaining the delicate balance between rapid response and scientific integrity while ensuring equitable access to treatments in affected regions.
