The Global Vaccine Action Plan set a target of minimal reporting ratio of 10 for vaccine safety monitoring for “Number of AEFI reported by country per 100,000 surviving infants per year and per country” as a proxy measure for an established AEFI reporting system in a country. A study was conducted to review AEFI reports communicated each year through the World Health Organization/United Nations Children’s Fund Joint Reporting Form on Immunization from 2000 to 20151.
User manual for the revised WHO classification for the causality assessment of an adverse event following immunization (AEFI) – Second edition
The second edition of the user manual for the revised WHO classification for the causality assessment of an adverse event following immunization (AEFI) was developed by the WHO with support from the Global Advisory Committee for Vaccine Safety (GACVS). This was based on the findings of a scientific study, “Indo- Zimbabwe inter-country study to assess the inter-rater reliability of the WHO AEFI causality assessment methodology and the utility of the new WHO AEFI causality assessment software” that was conducted in April 2017. The study determined that there was realistic agreement between assessors in their findings of assessment and identified areas of the methodology that could be made even more robust by the use of more accurate and clearer language, semantics and graphics. In addition recent surveillance systems and research studies have shed new evidence on areas such as, “substandard and falsified vaccines” and “immunization anxiety” that have been incorporated into this edition.
The sixth meeting of the Global Vaccine Safety Initiative (GVSI) was held in Kuala Lumpur from 11 to 12 October 2017. It was hosted by the Ministry of Health of Malaysia in cooperation with the Association of Southeast Asian Nations (ASEAN) Pharmaceutical Product Working Group. Participants reported on initiatives relevant to the Global Vaccine Safety Blueprint objectives, shared experiences to strengthen vaccine pharmacovigilance, and identified needs and opportunities for further development. This annual meeting provides an important platform for exchange, interaction and information between Member States and partners, as well as opportunities for partnership-building and planning.
Stakeholders Meeting on Maternal Interventions Vigilance: Safety Monitoring and Surveillance in Vaccine and other Research Settings
Vaccination during pregnancy can confer protection to mothers and their offspring with new products currently in clinical development. Monitoring the safety of those products after registration, in particular in low- and middle-income countries will require well organized surveillance systems. Last November WHO convened a stakeholder meeting with experts from WHO Collaborating Centres in vaccine safety, technical agencies with an interest in immunization in pregnancy, academia from all WHO regions, regulatory and industry umbrella organizations.
GACVS held its 37th meeting in Geneva, Switzerland, on 6-7 December 2017. The Committee examined three vaccine specific safety issues: progress with pharmacovigilance readiness for the RTS,S malaria vaccine pilot countries, and updates on the safety profiles of both rotavirus and dengue vaccines. It also reviewed three generic issues: the inter-rater reliability of the revised causality assessment algorithm for serious adverse events following immunization (AEFI), guidance on prevention and management of immunization-triggered stress reactions, and harmonized approaches for the vigilance of vaccine and other interventions during pregnancy.
GVSI reference documents
- Global Vaccine Safety Blueprint - landscape analysis
- Global Vaccine Safety Blueprint
- The Decade of Vaccine - Global Vaccine Action Plan
Immunization and vaccines safety in WHO regions
Last update: 13 April 2018