About this Research Topic
The COVID-19 pandemic has underscored the need for timely provision of new therapies or vaccines with demonstrable effectiveness, safety and quality to cope with a pandemic. This requires the regulatory system to have the capacity, during a pandemic, to conduct a rapid assessment of the effectiveness, safety and quality of (innovative) therapies with potential protective and/or curative effect against the pandemic pathogen. After marketing authorization, vaccines are used on a wide scale throughout and vaccination campaigns are rolled out in a short time span. It is therefore extremely important to assess the safety profile during the roll-out of new vaccines in the post-marketing phase.
The goal of this Research Topic is to learn from the challenges facing pharmacovigilance during past pandemics and describe lessons learned on how we can better prepare for a future pandemic. This includes research on the use of different types of data-sources for vaccine safety studies, methods development and innovation for vaccine safety analysis and automation in drug safety research. This topic also welcomes contributions on communication to the public during a pandemic about vaccine safety and regulation.
Original Research articles, Reviews, Policy Briefs, and Perspectives addressing, but not limited to, the following themes are welcome in this Research Topic:
• Innovative Regulatory Frameworks: Exploring adaptive licensing pathways, real-world evidence generation, and post-market surveillance strategies for pandemic vaccines.
• Vaccine Safety Monitoring: Investigating pharmacovigilance systems, adverse event reporting, and risk communication strategies in pandemic settings.
• Ethical Considerations: In the context of pandemics, examine issues of equity, access, informed consent, and vaccine hesitancy.
• Global Collaboration: Analyzing international cooperation in vaccine development, regulation, and distribution during pandemics.
• Lessons Learned: Identifying key takeaways from the COVID-19 pandemic and previous outbreaks to inform future vaccine safety and regulatory practices.
We encourage submissions from diverse perspectives, including those from low- and middle-income countries, to ensure a comprehensive understanding of global challenges and solutions. By fostering collaboration and knowledge exchange, this research topic aims to contribute to a more resilient and safe vaccine landscape for future pandemic preparedness.
The goal of this Research Topic is to learn from the challenges facing pharmacovigilance during past pandemics and describe lessons learned on how we can better prepare for a future pandemic. This includes research on the use of different types of data-sources for vaccine safety studies, methods development and innovation for vaccine safety analysis and automation in drug safety research. This topic also welcomes contributions on communication to the public during a pandemic about vaccine safety and regulation.
Original Research articles, Reviews, Policy Briefs, and Perspectives addressing, but not limited to, the following themes are welcome in this Research Topic:
• Innovative Regulatory Frameworks: Exploring adaptive licensing pathways, real-world evidence generation, and post-market surveillance strategies for pandemic vaccines.
• Vaccine Safety Monitoring: Investigating pharmacovigilance systems, adverse event reporting, and risk communication strategies in pandemic settings.
• Ethical Considerations: In the context of pandemics, examine issues of equity, access, informed consent, and vaccine hesitancy.
• Global Collaboration: Analyzing international cooperation in vaccine development, regulation, and distribution during pandemics.
• Lessons Learned: Identifying key takeaways from the COVID-19 pandemic and previous outbreaks to inform future vaccine safety and regulatory practices.
We encourage submissions from diverse perspectives, including those from low- and middle-income countries, to ensure a comprehensive understanding of global challenges and solutions. By fostering collaboration and knowledge exchange, this research topic aims to contribute to a more resilient and safe vaccine landscape for future pandemic preparedness.
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.
