According to the CIOMS/WHO Working Group on Vaccine Pharmacovigilance, Vaccine pharmacovigilance is defined as “the science and activities relating to the
- Detection,
- Assessment,
- Understanding, and
- Communication of adverse events following immunization and other vaccine- or immunization-related issues, and to the prevention of untoward effects of the vaccine or immunization”
Goal of Vaccine Pharmacovigilance: Early detection of and appropriate and timely response to AEFIs in order to minimize negative effects to the health of individuals and lessen the potential negative impact on immunization of the population
Vaccine Pharmacovigilance Guidance Material:
- Vaccine pharmacovigilance – Introduction
- Post Marketing Vaccine vigilance
- Immunization safety surveillance
- Spontaneous AEFI reports
- Vaccination Failure
- Causality assessment of AEFI’s
- Vaccine product-related & Vaccine quality defect-related reactions and case study
- Immunization error related reactions and case study
- Immunization stress related reaction
- AEFI- Coincidental event