Sep 21, 2021 | Basic page

Overview of the AU-3S Joint Management Group

Due to relatively low levels of historical adverse event reporting in African countries, AU-3S is focused on strengthening the capacity for detecting and assessing safety signals that potentially would not be picked up in a single country’s data. The AU-3S Joint Signal Management (JSM) Group has been set-up to validate, prioritise, and assess cross-country signals based on integrated data. Currently, the AU-3S JSM Group is focused solely on reviewing COVID-19 vaccine related safety data but aims to expand its scope to additional products as the AU-3S programme scales in the future.

The AU-3S JSM Group does not replace the function of the national health product safety committees, but rather is designed to support and work with these national committees. It is not a decision-making body, but it will share its findings and recommendations with national committees for determining actions to be taken in country. The AU-3S JSM Group aims to also communicate findings to a wider AU audience through the AUDA network.

Additionally, the AU-3S JSM Group aims to:

  • Promote collaboration on the topic of safety surveillance amongst African member countries

  • Be a forum for technical support from reference medical products regulatory authorities to African regulatory authorities and other relevant public health programmes

  • Strengthen the capabilities of AU-3S JSM Group members through engagement with experts from reference regulators and sharing of experiences / best practices across member countries

The data mining runs for analysis by the AU-3S JSM Group Secretariat are performed and assessed fortnightly. Subsequent AU-3S JSM Group meetings are held as frequently as required to ensure signals are assessed without delay, enabling national committees and other bodies to effectively act on any AU-3S JSM Group recommendations. The frequency of meetings is therefore determined by the volume of data, and corresponding number of signal reports, that are to be assessed. The AU-3S JSM Group is now operational, with its kick-off meeting held on 21 April 2021 and first operational meeting held on 19 May 2021.