Post-licensure vaccine safety

Key point

Spontaneous reporting is the cornerstone of most post-licensure safety monitoring systems because of its relative ease of implementation and ability to capture unexpected events.

Post-licensure surveillancePost-licensure surveillance (also known as post-marketing surveillance)Pharmacovigilance conducted after a product has been licensed and introduced for use in a population. of vaccine safety is critical. The conditions and reasons for safety monitoring change following licensureLicensureThe granting of a license to conduct a regulated procedure, for example, to conduct a trial of a new vaccine or to approve a vaccine for routine delivery to the public in a vaccination programme. and introduction of a new vaccine.

Passive surveillance systems

Passive surveillance systems

Active surveillance systems

Post-licensure clinical trials and phase IV surveillance studies
Large linked databases (LLDBs)
Clinical centers, including the Clinical Immunization Safety Assessment (CISA) centers
  • More recently, tertiary clinical centers have been used to conduct research on immunization-associated health risks.
  • The USA's Clinical Immunization Safety Assessment (CISA) Network is a national network of six medical research centers with expertise in immunization safety conducting clinical research on immunization-associated health risks. Established in 2001 as a collaborative project between the CDC, six medical research centers, and American Health Insurance Plans, CISA conducts clinical research on vaccine adverse events and the role of individual variation.21