Iterating Overnight: Using Cardboard to Teach Audio During a Pandemic

Prototyping is a core element of engineering and technology activity, giving form to design concepts and facilitating iteration and testing. With the rise of the "maker movement,"higher fidelity forms of prototyping have often been privileged, without deep investigation into prototyping activities that support materially-focused exploration across different levels of fidelity. In this paper, we describe how students in an interdisciplinary undergraduate audio engineering course adapted to a loss of fabrication equipment and the COVID-19 pandemic, relying more heavily on cardboard prototypes as they "iterated overnight"at home to realize the design of their loudspeaker. We analyzed a range of iterative prototypes using a prototyping framework we operationalized from Lim, Tenenberg, and Stolterman, describing the filtering and manifestation dimensions across a range of student projects. We reflect upon the trajectories of prototyping, considering strengths and weaknesses of different types of materials in supporting student exploration and the pedagogical supports that may be needed to encourage this exploration.

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.

Building knowledge, optimising physical and mental health and setting up healthier life trajectories in South African women (Bukhali): a preconception randomised control trial part of the Healthy Life Trajectories Initiative (HeLTI).

INTRODUCTION: South Africa's evolving burden of disease is challenging due to a persistent infectious disease, burgeoning obesity, most notably among women and rising rates of non-communicable diseases (NCDs). With two thirds of women presenting at their first antenatal visit either overweight or obese in urban South Africa (SA), the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and NCDs. METHODS AND ANALYSIS: Bukhali is the first individual randomised controlled trial in Africa to test the efficacy of a complex continuum of care intervention and forms part of the Healthy Life Trajectories Initiative (HeLTI) consortium implementing harmonised trials in Canada, China, India and SA. Starting preconception and continuing through pregnancy, infancy and childhood, the intervention is designed to improve nutrition, physical and mental health and health behaviours of South African women to offset obesity-risk (adiposity) in their offspring. Women aged 18-28 years (n=6800) will be recruited from Soweto, an urban-poor area of Johannesburg. The primary outcome is dual-energy X-ray absorptiometry derived fat mass index (fat mass divided by height2) in the offspring at age 5 years. Community health workers will deliver the intervention randomly to half the cohort by providing health literacy material, dispensing a multimicronutrient supplement, providing health services and feedback, and facilitating behaviour change support sessions to optimise: (1) nutrition, (2) physical and mental health and (3) lay the foundations for healthier pregnancies and early child development. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Human Ethics Research Committee University of the Witwatersrand, Johannesburg, South Africa (M1811111), the University of Toronto, Canada (19-0066-E) and the WHO Ethics Committee (ERC.0003328). Data and biological sample sharing policies are consistent with the governance policy of the HeLTI Consortium (https://helti.org) and South African government legislation (POPIA). The recruitment and research team will obtain informed consent. TRIAL REGISTRATION: This trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 25 March 2019 (identifier: PACTR201903750173871). PROTOCOL VERSION: 20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.

COVID-19 antibody testing: From hype to immunological reality.

The potential role for serological tests in the current COVID-19 pandemic has generated very considerable recent interest across many sectors worldwide, inter alia pathologists seeking additional weapons for their armoury of diagnostic tests; epidemiologists seeking tools to gain seroprevalence data that will inform improved models of the spread of disease; research scientists seeking tools to study the natural history of COVID-19 disease; vaccine developers seeking tools to assess vaccine efficacy in clinical trials; and companies and governments seeking tools to aid return-to-work decision-making. However, much of the local debate to date has centred on questions surrounding whether regulatory approval processes are limiting access to serological tests, and has not paused to consider the intrinsically limiting impact of underlying fundamental biology and immunology on where and how different COVID-19 serological tests can usefully be deployed in the response to the current pandemic. We review, from an immunological perspective, recent experimental evidence on the time-dependency of adaptive immune responses following SARS-CoV-2 infection and the impact of this on the sensitivity and specificity of COVID-19 antibody tests made at different time points post infection. We interpret this scientific evidence in terms of mooted clinical applications for current COVID-19 antibody tests in identifying acute infections, in confirming recent or past infections at the individual and population level, and in detecting re-infection and protective immunity. We conclude with guidance on where current COVID-19 antibody tests can make a genuine impact in the pandemic.