Pandemic Preparedness in Vaccine Safety and Regulation

In the context of global health crises like the COVID-19 pandemic, the rapid development and deployment of vaccines are crucial to combating spread and mitigating impact. This urgency places significant pressure on regulatory systems to swiftly assess the safety, quality, and efficacy of innovative therapies for pandemic pathogens. As vaccines are rapidly authorized and deployed globally, assessing their post-marketing safety profiles becomes paramount. Despite the scale and urgency of these measures, recurring challenges in pharmacovigilance have been observed, highlighting gaps in current practices and the need for robust safety monitoring systems during pandemics.

This Research Topic aims to synthesize knowledge from past pandemic experiences to enhance future preparedness. By analyzing challenges encountered in pharmacovigilance during previous global health emergencies, the topic will explore innovative methods to improve vaccine safety. It specifically seeks to advance understanding in the use of diverse data sources for safety studies, develop new methods for safety analysis, enhance automation in drug safety research, and improve public communication on vaccine safety and regulation during pandemics.

To gather further insights into strengthening the vaccine safety framework, we welcome articles addressing, but not limited to, the following themes:

• Innovative Regulatory Frameworks: Adaptive licensing, real-world evidence, and post-market surveillance.
• Vaccine Safety Monitoring: Enhancements in pharmacovigilance systems, adverse event reporting, and risk communication.
• Ethical Considerations: Equitable access, informed consent, and addressing vaccine hesitancy during pandemics.
• Global Collaboration: International cooperation in vaccine development, regulation, and distribution.
• Lessons Learned: Key insights from managing the COVID-19 and previous pandemics to inform future practices.

Contributions from diverse geographical regions and economic backgrounds are encouraged to ensure a well-rounded discourse and the development of universally applicable strategies.

Keywords: Vaccine safety, pandemic preparedness, post-authorization studies, spontaneous reporting systems

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.