The general principles for the surveillance of adverse events following immunization (AEFIs) are similar in all countries. However, approaches may differ due to factors such as how immunization services are organized and the level of resources available.

The first half of the module describes the the central role of the national regulatory authority (NRA), the national pharmacovigilance center (PVC) and the national immunization programme (NIP) along with the role of the AEFI review committee; other participants are also briefly introduced.

In the second half of the Module you will look into the international services available to support vaccine safety in countries. You will understand how national and international agencies work together and how information flows between them and countries.

Module outcomes

By the end of this module you should be able to:

  • 1list the main functions or services for vaccine safety, including national and international bodies, as well as manufacturers;
  • 2describe the relevant areas of responsibility and (if applicable) the areas of collaboration between the National Regulatory Authority, Pharmacovigilance Center and Immunization Programmes within your own country;
  • 3identify the mechanisms by which an AEFI seen in a clinic can be reported to the national regulatory authority;
  • 4Summarize information flows between institutions at national level (immunization clinics, NRAs, etc.) and international bodies.