The Vigilance Hub is the back-end system of the Med Safety App. The Vigilance Hub is available to staff of national regulators and immunisation programmes (NRAs and EPIs) based on granted access permissions.

The Vigilance Hub allows a user to:

• View all submitted reports, from the Med Safety App and other linked channels.

• Edit case reports submitted. This is particularly relevant for updating cases with any follow-up information obtained via case investigations. This functionality is also important when one needs to recode a drug-name if a non-MedDRA term had originally been captured or to update vaccine names if the vaccine drop-down list was not used when generating the report.

• Manually enter paper form cases directly into the Vigilance Hub.

• Export reports of cases.

• Analyse volume and sources of cases received for specified time periods.

• Configure news items for users of the Med Safety App and create watch lists for medical products of interest – therefore acting as a two-way communication channel.

It is important to note that reports entered into or updated within the Vigilance Hub are automatically updated in the VigiFlow environment.

There are two access levels that can be granted to Vigilance Hub users, allowing for safety data access to be tailored to country requirements. Both ‘standard users’ and ‘organisation leads’ can create and update case reports. Additionally, ‘organisation leads’ can access analytics and download functionalities for all cases in the Vigilance Hub. They can also specify what permissions each ‘standard user’ is to receive when creating new accounts (e.g., may limit EPI users to only be able to access vaccine related reports). The AU-3S team is putting in place a network of national Vigilance Hub super users so that each country using the tool can be self-supporting and manage their own user access requirements going forward. Further information about capability strengthening via the Vigilance Hub super user network can be found here .

A detailed guidance document outlining how to use the Vigilance Hub can be found here. For more information about the Vigilance Hub, please click here.