Statement of the Global Advisory Committee on Vaccine Safety on AEFI related to Pentavalent vaccine (DTP HepB Hib) use in Asia
The Global Advisory Committee on Vaccine Safety (GACVS) held its regular meeting on 12-13 June 2013. On that occasion, GACVS reviewed the experience of four Asian countries that are using 5-in-one vaccines against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type b. A statement has been prepared that describes the data reviewed and the committee’s conclusion. This statement will subsequently be part of the regular GACVS report scheduled to be published on 19 July 2013.
Causality assessment of an adverse event following immunization (AEFI)
Serious or unexpected AEFI can rarely manifest following immunization, and it is important to assess if there is a causal relationship with the vaccination. The fact that a vaccine was administered within a reasonable time period does not automatically imply that the vaccine caused the event. This user manual describes the revised WHO methodology incorporating recent updates of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance. This simple, rational and “hands on” method guides assessors through application of logic and experience to arrive at the best conclusion with available evidence.
The current GVSI portfolio includes activities reviewed by the GVSI PG in November 2012, some of which are expected to extend up to 2020, that is the duration of the Decade of Vaccine endorsed by the World Health Assembly. All GVSI projects are listed and monitored through the portfolio.
Portfolio activities benefit from the visibility provided by the GVSI through its broad base of stakeholders. GVSI participants and stakeholders may refer to the portfolio to assist in making funding decisions. Interested parties can request further details on the nature of the activities, outputs, outcomes and expected impact by contacting the responsible contact person or on request to GVSI@who.int
For optimal vaccine safety monitoring and meaningful analysis of Adverse Event Following Immunization (AEFI) data, systematic and standard collection of critical parameters is essential. A limited number of variables are required to properly manage AEFI information. This includes a unique identification of the report, the primary source of information, patient characteristics, details of the event(s) and vaccine(s) of interest and the possibility of collecting additional information if needed.
Comparing AEFI reporting forms from a sample of emerging countries, a WHO working group developed a core data set that was endorsed by the Global Advisory Committee on Vaccine Safety (GACVS) in June 2012. This data set includes 22 variables with 10 identified as critical. This simple structure is expected to provide countries with a harmonized template that will simplify AEFI reporting and allow for comparisons and pooling of essential information for action.
- The Global Vaccine Safety Initiative (GVSI)
- Global Vaccine Safety Blueprint
- Strategic Advisory Group of Experts (SAGE) on Immunization
- The Decade of Vaccine - Global Vaccine Action Plan
- Global Vaccine Safety Blueprint - landscape analysis
Global Vaccine Safety initiative activities portfolio 2012-2020