Assessment 5
Question 2
Every country should establish an AEFI Review Committee to review individual serious and unusual AEFIs and other AEFIs referred to it by expert groups, to assess potential causal links between AEFIs and a vaccine (or vaccine lot). Furthermore, the AEFI Review Committee should monitor reported AEFI data for potential signals of previously unrecognized vaccine-related adverse events , and provide recommendations for further investigation, education, corrective action and communication with interested parties, including the media.
Which of these people are suitable as members of a national AEFI review committee?
Select one or more:
| A. National EPI Manager. | |
| B. A university professor of epidemiology. | |
| C. The director of the National Regulatory Authority. | |
| D. A senior investigator in immunology from the national research laboratory. | |
| E. A forensic physician. | |
| F. The transport manager of the company that distributes the vaccine. |
Answers B, D and E are correct.
An AEFI Review Committee should be composed of members that are independent of the immunization programme. It should represent a wide range of specialists whose expertise may add to the task of reviewing the AEFIs. Areas of expertise would include paediatrics, neurology, internist, forensic physician, pathology, microbiology, immunology and epidemiology. Medical experts in particular should be invited for the analysis of special clinical events.
To avoid conflict of interest, the national EPI manager, vaccine laboratory scientists, representatives of the national vaccine regulatory authority, and regional/district EPI officers should not be included as members in the committee, however, should be available to support it in its functions.