SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues

Area of Science:

• Virology
• Immunology
• Regulatory Science

Background:

• The COVID-19 pandemic necessitates rapid development and authorization of vaccines.
• International collaboration is crucial for addressing global health challenges.

Purpose of the Study:

• To discuss the utility of controlled human infection models (CHIMs) for accelerating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine development.
• To explore the role of CHIMs in the market authorization assessment process.
• To foster dialogue among diverse global stakeholders.

Main Methods:

• Convening an international webinar with participants from academia, regulatory bodies, funding agencies, and industry.
• Facilitating discussions on the application and challenges of CHIMs for vaccine research.
• Engaging stakeholders from low- and middle-income countries.

Main Results:

• Identified controlled human infection models as a promising strategy for expediting vaccine development timelines.
• Highlighted the potential of CHIMs to inform regulatory decision-making for vaccines.
• Emphasized the importance of inclusive global participation in vaccine research and development.

Conclusions:

• Controlled human infection models offer a viable pathway to accelerate the development and regulatory approval of SARS-CoV-2 vaccines.
• Continued international collaboration and knowledge sharing are essential for optimizing the use of CHIMs.
• Engaging diverse stakeholders, particularly from resource-limited settings, is key to equitable vaccine advancement.