COVID-19 Vaccine Safety Surveillance and Causality Assessment of Adverse Events Following Immunisation: Lessons from South Africa

Introduction: The South African Health Products Regulatory Authority (SAHPRA) utilises various AEFI reporting tools to monitor vaccine safety in the country. In 2020, SAHPRA in collaboration with the National Department of Health's (NDoH) Expanded Programme on Immunisation (EPI), joined the African Union Smart Safety Surveillance programme, as one of four pilot countries, to introduce an electronic adverse event following immunisation (AEFI) reporting system (Med Safety App) for healthcare professionals and consumers [1]. On 17/05/2021, the NDoH introduced its national COVID-19 vaccination programme. SAHPRA launched a microsite during 2021, to provide feedback to the public on AEFI with the COVID-19 vaccines. Objective(s): To provide an overview of COVID-19 vaccine safety surveillance and describe causality assessment outcomes for serious AEFI reported during the first year of COVID-19 vaccine administration. Method(s): All severe and/or serious AEFI are investigated by provincial EPI surveillance teams, followed by causality assessment conducted by the National Immunisation Safety Expert Committee (NISEC), using the World Health Organization (WHO) methodology [2]. Causality assessment outcomes are classified based on the final diagnoses determined during the assessment by NISEC according to WHO categories, seriousness, Medical Dictionary for Regulatory Activities (MedDRA) system organ class and patient demographics. Data were collected retrospectively from the SAHPRA COVID-19 AEFI microsite and the EPI national AEFI database. Result(s): By 01/04/2022, 33,063,221 COVID-19 vaccine doses had been administered, with 5 815 spontaneous AEFI reports (0.0173%) submitted. Of these, 2,571 (0.008%) were reported as serious. Spontaneous reporting of AEFI increased significantly compared to pre-COVID-19 vaccine introduction. The most frequently reported AEFIs were side effects already listed in the product information. No safety concerns were raised based on causality assessment outcomes for 273 serious cases analysed by 01/04/2022. Over two thirds of these cases were classified as coincidental (70.7%) as cardiac-, respiratory- or vascular disorders (MedDRA system organ class), with 12.1% classified as vaccine product related (see table below). The presentation will include all causality assessments conducted up to 31/08/2022, and more detailed information about causality assessed cases will be available in the public domain at the time of the conference and will be included in the presentation. Conclusion(s): Vaccine safety surveillance and monitoring trends of reported AEFI are vital measures to ensure that the benefits of immunisation are maintained in the interest of public health and efficient vaccination programmes. Transparent communication with the public is important to maintain public confidence in vaccines and prevent all AEFI being misinterpreted as caused by the vaccine.

COVID-19 Vaccine Safety Surveillance and Causality Assessment of Adverse Events Following Immunisation: Lessons from South Africa: An International Journal of Medical Toxicology and Drug Experience

Introduction: The South African Health Products Regulatory Authority (SAHPRA) utilises various AEFI reporting tools to monitor vaccine safety in the country. In 2020, SAHPRA in collaboration with the National Department of Health's (NDoH) Expanded Programme on Immunisation (EPI), joined the African Union Smart Safety Surveillance programme, as one of four pilot countries, to introduce an electronic adverse event following immunisation (AEFI) reporting system (Med Safety App) for healthcare professionals and consumers [1]. On 17/05/2021, the NDoH introduced its national COVID-19 vaccination programme. SAHPRA launched a microsite during 2021, to provide feedback to the public on AEFI with the COVID-19 vaccines. Objective: To provide an overview of COVID-19 vaccine safety surveillance and describe causality assessment outcomes for serious AEFI reported during the first year of COVID-19 vaccine administration. Methods: All severe and/or serious AEFI are investigated by provincial EPI surveillance teams, followed by causality assessment conducted by the National Immunisation Safety Expert Committee (NISEC), using the World Health Organization (WHO) methodology [2]. Causality assessment outcomes are classified based on the final diagnoses determined during the assessment by NISEC according to WHO categories, seriousness, Medical Dictionary for Regulatory Activities (MedDRA) system organ class and patient demographics. Data were collected retrospectively from the SAHPRA COVID-19 AEFI microsite and the EPI national AEFI database. Results: By 01/04/2022, 33,063,221 COVID-19 vaccine doses had been administered, with 5 815 spontaneous AEFI reports (0.0173%) submitted. Of these, 2,571 (0.008%) were reported as serious. Spontaneous reporting of AEFI increased significantly compared to pre-COVID-19 vaccine introduction. The most frequently reported AEFIs were side effects already listed in the product information. No safety concerns were raised based on causality assessment outcomes for 273 serious cases analysed by 01/04/2022. Over two thirds of these cases were classified as coincidental (70.7%) as cardiac-, respiratory- or vascular disorders (MedDRA system organ class), with 12.1% classified as vaccine product related (see table below). The presentation will include all causality assessments conducted up to 31/08/2022, and more detailed information about causality assessed cases will be available in the public domain at the time of the conference and will be included in the presentation. Conclusion: Vaccine safety surveillance and monitoring trends of reported AEFI are vital measures to ensure that the benefits of immunisation are maintained in the interest of public health and efficient vaccination programmes. Transparent communication with the public is important to maintain public confidence in vaccines and prevent all AEFI being misinterpreted as caused by the vaccine.

Risk communication and community engagement-unlocking the key to South Africa?s response to SARS-CoV-2

Background. COVID-19 has changed the way that governments communicate and engage with citizens. In emergencies, effective communication must be immediate, grounded in science, transparent, easy to understand and in language-appropriate messaging delivered through multiple and varied platforms. For the South African (SA) COVID-19 response, the intent was to design an agile, locally relevant Risk Communication and Community Engagement (RCCE) strategy as the pandemic was unfolding and to constantly evaluate its implementation. Early involvement of communities in the formulation and direction of a risk communication plan is essential to its success. Objective. To outline the significance of the RCCE???s robust communication strategy during the COVID-19 response and the lessons learnt in executing the strategy. Methods. This is a qualitative review of documents and reports generated and utilised by the RCCE Technical Working Group (TWG) and reflects the lessons learnt from discussions and multiple engagements at district, provincial and national levels. The review incorporates lessons learnt from international practice, resource documents from the World Health Organization (WHO), RCCE readiness and response to coronavirus disease, feedback from the Behavioural Science Ministerial Advisory Committee, input from the call centre, website and various established social media platforms. Results. Communication and building trust with multiple stakeholders begin before an outbreak and is a prerequisite to facilitate the timeous flow of information, particularly in the context of a rapidly evolving outbreak of a new disease, where the scientific community does not immediately have all the answers. Initial COVID-19 messages were therefore filled with challenges that ranged from the lack of scientific and epidemiological information to rumours, conspiracy theories and misinformation. The findings validate that empowering communities to act, strengthening public trust and community participation using multiple channels as well as timely responses to rumours and misinformation are important drivers of COVID-19 communication efforts in SA. Communication efforts must be accelerated to translate science into locally relevant languages and the impact of interventions must be measured to appropriately direct limited resources. Conclusion. The risk communication strategy incorporated several key lessons that could be used to improve communication and inform future emergency response communication that is immediate, science-based, transparent, inclusive and encourages community participation.

COVID-19 response in South African communities: Screening, testing, tracing and movement modelling.

In South Africa (SA), the first case of COVID-19 was reported on 5 March 2020 from a traveller who had returned from Italy. Increases in COVID-19 cases and deaths necessitated the design and implementation of community screening, testing, and tracing as a control strategy. The SA government's plans to implement community-based screening, testing, contact tracing and movement modelling during the early phases of the COVID-19 pandemic presented both opportunities and challenges. In this article, we present our experiences, opportunities and lessons for community-based COVID-19 response, anchoring these efforts in the primary healthcare system.