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.

The AU-3S JSM Group’s key roles are performed by a group of members and experts with support from a Secretariat.

The AU-3S JSM Group Secretariat is led by AUDA-NEPAD, with representatives from the country Secretariats for capacity strengthening and from reference regulatory authorities from outside the African continent to provide technical support as required. Country representatives on the Secretariat work with AUDA-NEPAD on signal detection, validation, and prioritisation activities.  They provide the link back to the national committee findings and investigate the status of individual cases as required.  In addition, they resolve any coding issues in the Vigilance Hub where non-MedDRA reaction terms have been used. Additionally, the Secretariat:

• Organises the meetings of the AU-3S JSM Group

• Takes minutes of AU-3S JSM Group meetings

• Communicates relevant information to key stakeholders

• Regularly reports to the AU-3S Steering Group

The AU-3S JSM Group members include representatives from member countries’ NRAs, EPIs, and national product safety committees. The Group is also supplemented with independent experts for key subject matter expertise. Core expertise areas for the AU-3S JSM Group include biostatistics with training in clinical pharmacology, epidemiology, immunology, microbiology, pathology, pharmacy, public health, toxicology, and vaccinology.  Additional experts will be called upon for specific topics as required. A view of the current AU-3S JSM Group composition by expertise, organisation, and country can be seen in the table below:

JSM Group | Members confirmed to date

AU-3S JSM Group members are responsible for clinical assessment of potential signals from member countries’ combined data. The scope of assessment currently is focused only of COVID-19 vaccine related data. This is complementary to causality assessments that may be performed by national committees. As needed, further clinical assessment of these signals can be conducted by continental safety assessment committees, including the African Advisory Committee on Vaccine Safety (AACVS), in consultation with national committees where additional information is required.

A chairperson and deputy chairperson have been nominated by the AU-3S JSM Group.

• Chairperson: Prof Hannelie Meyer, from South Africa is a member of the AU-3S JSM Group

• Deputy Chairperson: Mr Hudu Mogtari, from Ghana, is a member of the AU3-S JSM Group and from AUDA-NEPAD

The deputy chairperson acts in the absence of the chairperson or when the chairperson requests him/her to do so. The chairperson and deputy chairperson are to be appointed for a 1-year period, whereby they are responsible for the following roles:

• Presiding over JSM Group meetings

• Approving the invitation of required experts in consultation with the AU-3S JSM Group Secretariat

• Ensuring feedback on the AU-3S JSM Group’s activities is provided to the AU-3S Steering Group and/or other bodies as required

All AU-3S JSM Group members and invited experts are required to sign a conflict-of-interest declaration and must furthermore verbally declare any real, potential, or perceived conflicts of interest at the start of every AU-3S JSM Group meeting (based on the agenda). The chair is to decide whether or not the issue raised constitutes as a conflict of interest and subsequently propose the most suitable path forward. All AU-3S JSM Group members are not to be affiliated with the medical products industry.

The structure of the AU-3S JSM Group, and its membership, may be reviewed with future scope changes and/or on request by countries. Members of the AU-3S JSM Group should be appointed for a 2-year period. Membership of individual representatives may be reviewed by the AU-3S JSM Group chairperson, the Secretariat, and the AU-3S Steering Group based on criteria including:

• Failure to attend meetings without appropriate justification

• Conflict of interest arising from change in affiliation

• Breach of confidentiality

Finally, the AU-3S JSM Group Terms of Reference (key points discussed above) may be reviewed as and when required by AU-3S JSM Group members and/or the AU-3S Steering Group. This document can be downloaded here.