Interactions between AEFI and ADR surveillance systems

The National Regulatory Authority is usually the only agency with the mandate to ensure the safety, efficacy and quality of vaccines. While AEFI surveillance is a key function of National Regulatory Authorities, monitoring the safety of vaccines requires the involvement of both the National Immunization Programme and the National Regulatory Authority. Their good collaboration should be supported by clearly distinguishing their roles and responsibilities.

The most critical function necessary for meeting the National regulatory authority responsibility to ensure vaccine safety is a strong AEFI surveillance system closely integrated with the system of vaccination delivery.

Because the NRA may have limited knowledge of the structure and management of the National immunization programme, it is essential that the immunization programme manager be involved in AEFI surveillance and the roles of the two parties in this process must be clearly established.

Monitoring safety of vaccines
Integrating AEFI surveillance with system of vaccine delivery
Clear distribution of roles in reporting and detection

There have been several instances where NIPs and NRAs have failed to work with each other when developing national AEFI or ADR surveillance systems. This has often resulted in duplication of effort and a failure to capture all relevant data in one central repository. In addition, potential crises may go undetected through such confusion and the health-care providers may see this as an additional barrier to reporting AEFIs and ADRs.

Key point

A good collaboration between National Regulatory Authority and National Immunization Programme are usually critical components of a strong AEFI surveillance system.

In some countries where the NRA is not in a position to execute the aforementioned tasks, the National immunization programme may have taken over part of the activities of the NRA.