Safety, Surveillance & Pharmacovigilance

  • Vaccine Safety Monitoring & Global Surveillance Systems
  • Adverse Events Following Immunization (AEFI)
  • Risk Management Plans & Signal Detection
  • Immunotoxicology & Hypersensitivity
  • Post-Marketing Surveillance (VAERS, VSD, WHO platforms)
  • Real-Time Data Analytics for Safety Assessment

Safety, Surveillance & Pharmacovigilance are essential pillars of vaccine programs, ensuring that immunization benefits consistently outweigh potential risks across populations and time. This session focuses on the systems, methodologies, and scientific principles used to monitor vaccine safety before and after authorization. Continuous safety oversight strengthens confidence in vaccination and supports evidence-based decision-making throughout the vaccine lifecycle.

Insights shared at Vaccine Conferences highlight that vaccine safety assessment does not end at regulatory approval. Pre-licensure trials provide controlled safety data, but rare or long-term adverse events often emerge only after widespread use. Pharmacovigilance systems are designed to detect, assess, and manage these events through active and passive surveillance mechanisms operating at national and global levels.

The Safety, Surveillance & Pharmacovigilance session explores how post-marketing surveillance systems collect and analyze safety data from diverse sources. Spontaneous reporting systems, electronic health records, and sentinel surveillance networks enable timely identification of safety signals. Advanced analytical methods help distinguish true vaccine-related events from coincidental occurrences, reducing misinformation and unnecessary alarm.

Progress in vaccine safety monitoring has been driven by advances in data science, real-world evidence generation, and international collaboration. Signal detection algorithms, data linkage across healthcare systems, and global reporting platforms enhance sensitivity and specificity in safety assessments. These tools support rapid investigation and transparent communication of findings to regulators, healthcare providers, and the public.

This session also addresses risk communication and benefit–risk evaluation. Effective pharmacovigilance requires clear, timely, and accurate communication of safety information to maintain public trust. Contextualizing risks alongside vaccine benefits helps counter misinformation and supports informed consent. Ethical considerations include transparency, accountability, and responsiveness to public concerns.

Participants gain a comprehensive understanding of how safety surveillance systems protect individuals and populations. By integrating scientific rigor with proactive monitoring and communication strategies, this session underscores the importance of pharmacovigilance in sustaining confidence, guiding policy updates, and ensuring the long-term success of vaccination programs worldwide.

Systems Supporting Vaccine Safety Oversight

Pre- and Post-Licensure Evaluation

  • Assesses safety across development stages
  • Identifies rare adverse events

Active and Passive Surveillance

  • Combines reporting and monitoring systems
  • Enhances signal detection

Data Integration and Analytics

  • Links multiple health data sources
  • Improves assessment accuracy

Risk Communication Frameworks

  • Supports transparent public engagement
  • Strengthens informed decision-making

Why Pharmacovigilance Is Critical

Protecting Public Health
Identifies and manages safety risks

Maintaining Vaccine Confidence
Supports trust through transparency

Guiding Regulatory Action
Informs label updates and guidance

Responding to Emerging Signals
Enables timely investigation

Supporting Evidence-Based Policy
Aligns decisions with real-world data

 

Ensuring Long-Term Program Success
Sustains confidence in immunization systems

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