AU-3S Solutions for COVID-19 and Beyond

INTERIM SOLUTIONS

The accelerated development of COVID-19 vaccines, alongside the unprecedented scale for effective vaccine rollout, has heightened the need for robust safety surveillance in all countries. To support member states, the AU-3S team is – amongst others – implementing four programme solution initiatives:

Alongside the MHRA, facilitate the delivery of capability strengthening trainings covering different aspects of the safety surveillance value-chain, from data reporting and collection to causality assessments, to safety communications
Promotion of electronic vaccine data collection through the development of an AEFI form via the Med Safety App, and support to NRAs and EPIs for successful implementation
Establishment of the Data Integration and Signal Detection (DISD) system, to detect signals in combined cross-country data from African countries
Establishment and facilitation of the Joint Signal Management (JSM) Group to validate, prioritise, and assess the cross-country signal reports from the interim DISD system

capability strengthening

CAPBILITY STRENGTHENING

AU-3S is facilitating capability strengthening training sessions with AU-3S’s technical partner, the MHRA. These trainings aim to strengthen countries’ safety surveillance capacities across a comprehensive range of topics and are recommended to anyone involved or interested in effectively monitoring the safety of medical products. While these trainings aim to be suitable for future use and are therefore somewhat general to safety surveillance, specific considerations for COVID-19 vaccines are included where relevant.

The training package is grouped into 5 key modules – a detailed breakdown of the topics covered in each can be seen in the table below. The trainings are being given in a recorded webinar format. These recordings, and all associated presentations and/or resources such as written Q&As, can be accessed for in-country distribution and use using AUDA-NEPAD’s knowledge portal[LR1] .

Module	Title	Contents	Timing
1	Data collection	Introduction to pharmacovigilance Overview of spontaneous reporting schemes and promotion ADR data and vaccine specific considerations Tools and resources for data collection and management Good practice coding	January 2021
2	Signal detection and management	Causality assessment Signal detection, management, validation, and assessment Observe signal management meeting	February 2021
3	Benefit risk assessment	Risk assessment Risk management plans Periodic Safety Update Reports Role of pharmacoepidemiology in pharmacovigilance Regulatory decision making	March 2021
4	Safety communication	Risk communication – routine communication, crisis management, media handling, special considerations for vaccines Decision making in communications	April 2021
5	Pharmacovigilance Expert Advisory Committee	National Safety Committees – experience from the UK Joint committees A safety committee in action	May 2021

information on the au-3s med safety app

INFORMATION ON THE MED SAFETY APP

The AU-3S team has launched a vaccine-specific reporting form for the Med Safety App – an electronic data collection tool. The existing form in the Med Safety App was designed to report an adverse event from a medicine. Reports for Adverse Events Following Immunisation (AEFIs) have slightly different data requirements and are generally owned by the immunisation programmes. There exists a call from immunisation programmes to move to e-reporting of AEFIs using the same reporting tools as used for medicines. To achieve this, the AU-3S team developed a vaccine reporting form in the Med Safety App. This form is based on the WHO core variables for AEFI reporting, which is also the basis for existing paper reporting forms. The Med Safety App will support countries to collect AEFI reports effectively and timeously for COVID-19 and other vaccines, ensuring that all data required for causality assessments is available. The AU-3S programme assists countries to raise local awareness of the Med Safety App to ensure that it is well-utilised for electronic reporting.

To include a link to the article on the Med Safety App in the first edition of the AU-3S newsletter

data integration

WHAT IS THE DATA INTEGRATION AND SIGNAL DETECTION (DISD) SYSTEM?

The AU-3S programme aims to create a sustainable continental safety monitoring system to improve the safety of medical products for patients across Africa. Working in partnership with the MHRA, an interim Data Integration and Signal Detection (DISD) system has been created. The interim DISD system will enable the integration of safety data across African countries and the analysis of this data. The system’s initial scope for signal detection is vaccine data, due to the pressing need for improved safety surveillance for COVID-19 vaccines. Data will remain African-owned and African-controlled and should be able to be transferred into a future African pharmacovigilance system. The MHRA will share signal reports from data runs on cross-country data in the DISD system with the JSM group.

WHAT IS THE JOINT SIGNAL MANAGEMENT (JSM)?

Due to historically relatively low levels of adverse event reporting in African countries, AU-3S is focused on strengthening the regional capacity for detecting and assessing safety signals that potentially would not be picked up in a single country’s data. The Joint Signal Management (JSM) Group has been set-up to validate, prioritise, and assess these cross-country signals based on integrated data. This will be done for COVID-19 vaccines in the short-term and other priority medical products in the longer-term – purely in the interest of public health and safety. Additionally, the JSM Group will:

Promote collaboration on the topic of safety surveillance amongst African member countries
Be a forum for technical support from reference regulatory authorities to African regulatory authorities
Strengthen the capabilities of JSM Group members through engagement with reference regulators and experience / best practice sharing across member countries

The JSM Group’s key roles will be performed by members with support from a secretariat. Members include representatives from member countries’ NRAs, EPIs, and national committees. The secretariat will be led by AUDA-NEPAD, with representatives from countries for capability strengthening, and from the MHRA for technical support. The JSM Group will regularly share its findings and recommendations with national committees, and vice versa. The JSM Group will also communicate to a wider AU audience through the AUDA network.