The Politics of the Second Vaccine: Debates Surrounding Ebola Vaccine Trials in Eastern Democratic Republic of the Congo

Two experimental Ebola vaccines were deployed during the tenth Ebola epidemic (2018–20) in the Democratic Republic of the Congo (DRC). The first, the Ervebo vaccine manufactured by Merck, was used as part of a ring vaccination in the epicentre of the epidemic in North Kivu. In 2019, the prime- (Ad26.ZEBOV) and boost- (MVA-BN-Filo) vaccine manufactured by Johnson & Johnson (J&J) became the second vaccine against Ebola, deployed by the DRC-EB-001 vaccine trial in Goma, North Kivu. There was international debate as to the value and ethics of testing a second vaccine in an epidemic context. This article examines how this debate unfolded among actual and potential DRC-EB-001 trial participants in Goma. Drawing on ethnographic observation, interviews and focus groups, it explores how the trial was perceived and contested on the ground and situated in broader debates about the ethics of clinical trials, especially during the COVID-19 pandemic. We illustrate how debates around the ethics of clinical research are not simply centred on bioethical principles but are inseparable from local political dynamics and broader contests about governance, inequality and exclusion.

Contesting the crisis narrative: epidemic accounts in Sierra Leone, Tanzania, and Democratic Republic of the Congo.

Scientists and global commentators watched African countries closely in the early months of the COVID-19 pandemic, predicting an impending disaster: the virus was projected to overwhelm already weak health systems. These expectations were informed by imaginaries of Africa as an inevitable site of epidemic disaster. This paper draws on accounts from Sierra Leone, Tanzania, and Democratic Republic of the Congo to contrast global catastrophe framings with everyday imaginations and experiences of crisis and crisis management. Utilising ethnographic research, the paper initially explores how COVID-19 was understood in relation to previous epidemics, from HIV (human immunodeficiency virus) to Ebola, as well as political conflict. It then considers how global crisis narratives both inform and are in tension with everyday collective and personal experiences. The paper brings these empirical reflections into a conversation with theoretical debates on the discursive construction of crisis and its effects, and argues that these tensions matter because crisis framings have consequences.

Changing gear: Experiences of how existing qualitative research can adapt to an unfolding health emergency.

Long-term research projects are not always able to adapt to a new crisis and incorporate characteristics and approaches of rapid research to produce useful data quickly. Project AViD was a programme of research that ran between 2018 and 2022 to examine factors that shape vaccine confidence. The project initially focused on five country case studies looking at vaccines for Ebola, Measles, Rift Valley Fever and Zika. The COVID-19 pandemic emerged during this time and provided an opportunity to contribute to the pandemic's 'million-dollar question'-how to deploy COVID-19 vaccines. Drawing on our experience as researchers, and specifically from AViD, we propose seven factors that can influence when and how longer-term qualitative research projects can adapt and contribute to the response to an unfolding health emergency. These include: (1) the phase of research in which the emergency hits; (2) the relative significance of the emergency in the research setting; (3) the specific methods and research team capacities; (4) existing operational links; (5) supportive ecosystems; (6) flexibility in research contracting and funding; and (7) the research team attitude and approach. We close with two considerations for longer-term research projects that find themselves having to "change gear" amid a public health emergency-the need to re-assess risks and benefits and the need to protect equitable partnerships.

Human preparedness: Relational infrastructures and medical countermeasures in Sierra Leone.

This paper examines health worker experiences in two areas of post-epidemic preparedness in Sierra Leone - vaccine trials and laboratory strengthening - to reflect on the place of people in current models of epidemic response. Drawing on ethnographic research and interviews with health workers in the aftermath of Ebola, it explores the hopes and expectations that interventions foster for frontline workers in under-resourced health systems, and describes the unseen work involved in sustaining robust response infrastructures. Our analysis focuses on what it means for the people who sustain health systems in an emergency to be 'prepared' for an epidemic. Human preparedness entails more than the presence of a labour force; it involves building and maintaining 'relational infrastructures', often fragile social and moral relationships between health workers, publics, governments, and international organisations. The COVID-19 pandemic has underscored the value of rethinking human resources from an anthropological perspective, and investing in the safety and support of people at the forefront of response. In describing the labour, personal losses, and social risks undertaken by frontline workers for protocols and practicality to meet in an emergency context, we describe the social process of preparedness; that is, the contextual engineering and investment that make response systems work.

Family Planning in the Sierra Leone Ebola Outbreak: Women's Proximal and Distal Reasoning.

Sierra Leone was highly impacted by the 2014-2016 West Africa Ebola outbreak, with 3,955 recorded deaths. Already stressed maternal health services were deeply affected by the outbreak due to fears of viral transmission, reallocation of maternity staff, and broader policies to stop transmission including travel restrictions. This research sought to explore women's perspectives on delaying pregnancy during the Ebola outbreak using family planning methods. Qualitative data collection took place in Kambia District in 2018 and included 35 women participants, with women who were either family planning users or nonusers at the time of the outbreak. Women reported a variety of reasons for choosing to take or not to take family planning during the outbreak, which we categorized as proximal (directly related to the outbreak) or distal (not directly outbreak related). Proximal reasons to take family planning included to avoid interacting with health care spaces where Ebola could be transmitted, to avoid the economic burden of additional children in a time when economic activities were curtailed and to return to school when education resumed postoutbreak. Distal reasoning included gender roles affecting women's decision making to seek family planning, concerns related to the physiological side effects of family planning, and the economic burden of paying for family planning. Women's perspectives for choosing to take or not take family planning during the Sierra Leone Ebola crisis had not been explored prior to this paper. Using the lens of family planning to consider how women choose to access health care in an outbreak gives us a unique perspective into how all health care interactions are impacted by a generalized outbreak of Ebola, and how outbreak responses struggle to ensure such services remain a priority.

"Are You Sure It's Not the Corona Vaccine?" An Ebola Vaccine Trial During COVID-19 in DRC.

The COVID-19 pandemic began as an Ebola epidemic was unfolding in the Democratic Republic of the Congo. In this article, we examine how COVID-19 influenced experiences of an Ebola vaccine trial and attitudes towards medical research in Goma. First, critical debates about vaccine research became a forum in which to contest ineffective local governance and global inequality. Second, discussions about new COVID-19 therapeutics reignited critique of Western biomedical colonialism. Third, rumors were made powerful through everyday observations of the unexpected adaption of Ebola trial procedures in the pandemic. This illustrates the difficulties of maintaining participants' trust, when circumstances dictate protocol alterations mid-trial.

Protocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo.

INTRODUCTION: Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness. METHODS AND ANALYSIS: This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1 year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were passively recorded until 1 month post dose 2. 1000 safety subset participants were telephoned at 1 month post dose 2 to collect SAEs. 500 pregnancy subset participants were contacted to collect SAEs at D7 and D21 post dose 1 and at D7, 1 month, 3 months and 6 months post dose 2, unless delivery was before these time points. The first 100 infants born to these women were given a clinical examination 3 months post delivery. Due to COVID-19 and temporary suspension of dose 2 vaccinations, at least 50 paediatric and 50 adult participants were enrolled into an immunogenicity subset to examine immune responses following a delayed second dose. Samples collected predose 2 and at 21 days post dose 2 will be tested using the Ebola viruses glycoprotein Filovirus Animal Non-Clinical Group ELISA. For qualitative research, in-depth interviews and focus group discussions were being conducted with participants or parents/care providers of paediatric participants. ETHICS AND DISSEMINATION: Approved by Comité National d'Ethique et de la Santé du Ministère de la santé de RDC, Comité d'Ethique de l'Ecole de Santé Publique de l'Université de Kinshasa, the LSHTM Ethics Committee and the MSF Ethics Review Board. Findings will be presented to stakeholders and conferences. Study data will be made available for open access. TRIAL REGISTRATION NUMBER: NCT04152486.

Vaccine Confidence and Hesitancy at the Start of COVID-19 Vaccine Deployment in the UK: An Embedded Mixed-Methods Study.

Background: Approval for the use of COVID-19 vaccines has been granted in a number of countries but there are concerns that vaccine uptake may be low amongst certain groups. Methods: This study used a mixed methods approach based on online survey and an embedded quantitative/qualitative design to explore perceptions and attitudes that were associated with intention to either accept or refuse offers of vaccination in different demographic groups during the early stages of the UK's mass COVID-19 vaccination programme (December 2020). Analysis used multivariate logistic regression, structural text modeling and anthropological assessments. Results: Of 4,535 respondents, 85% (n = 3,859) were willing to have a COVID-19 vaccine. The rapidity of vaccine development and uncertainties about safety were common reasons for COVID-19 vaccine hesitancy. There was no evidence for the widespread influence of mis-information, although broader vaccine hesitancy was associated with intentions to refuse COVID-19 vaccines (OR 20.60, 95% CI 14.20-30.30, p < 0.001). Low levels of trust in the decision-making (OR 1.63, 95% CI 1.08, 2.48, p = 0.021) and truthfulness (OR 8.76, 95% CI 4.15-19.90, p < 0.001) of the UK government were independently associated with higher odds of refusing COVID-19 vaccines. Compared to political centrists, conservatives and liberals were, respectively, more (OR 2.05, 95%CI 1.51-2.80, p < 0.001) and less (OR 0.30, 95% CI 0.22-0.41, p < 0.001) likely to refuse offered vaccines. Those who were willing to be vaccinated cited both personal and public protection as reasons, with some alluding to having a sense of collective responsibility. Conclusion: Dominant narratives of COVID-19 vaccine hesitancy are misconceived as primarily being driven by misinformation. Key indicators of UK vaccine acceptance include prior behaviors, transparency of the scientific process of vaccine development, mistrust in science and leadership and individual political views. Vaccine programmes should leverage the sense of altruism, citizenship and collective responsibility that motivated many participants to get vaccinated.

Bringing the social into vaccination research: Community-led ethnography and trust-building in immunization programs in Sierra Leone.

BACKGROUND: Vaccine hesitancy is a complex, contested social phenomenon and existing research highlights the multifaceted role of trust in strengthening vaccine confidence. However, understanding public engagement with vaccination through the lens of (mis)trust requires more contextual evidence on trust's qualitative determinants. This includes expanding the geographic focus beyond current studies' focus on High Income Countries. Furthermore, obstacles remain in effectively integrating social science findings in the design of vaccine deployment strategies, and in ensuring that those who implement interventions and are affected by them are directly involved in producing knowledge about vaccination challenges. METHODS: We piloted a community-led ethnographic approach, training Community Health Workers (CHWs) in Kambia District, Sierra Leone, in qualitative social science methods. Methods included participant observation, participatory power mapping and rumour tracking, focus group discussions and key stakeholder interviews. CHWs, with the support of public health officials and professional social scientists, conducted research on vaccination challenges, analysed data, tested new community engagement strategies based on their findings and elicited local perspectives on these approaches. RESULTS: Our findings on vaccine confidence in five border communities highlighted three key themes: the impact of prior experiences with the health system on (mis)trust; relevance of livelihood strategies and power dynamics for vaccine uptake and access; and the contextual nature of knowledge around vaccines. Across these themes, we show how expressions of trust centered on social proximity, reliability and respect and the role of structural issues affecting both vaccine access and confidence. The pilot also highlighted the value and practical challenges to meaningfully co-designed research. CONCLUSION: There is scope for broader application of a community-led ethnographic approach will help redesign programming that is responsive to local knowledge and experience. Involving communities and low-cadre service providers in generating knowledge and solutions can strengthen relationships and sustain dialogue to bolster vaccine confidence.

Violence against children during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic has affected children's risk of violence in their homes, communities and online, and has compromised the ability of child protection systems to promptly detect and respond to cases of violence. However, the need to strengthen violence prevention and response services has received insufficient attention in national and global pandemic response and mitigation strategies. In this paper, we summarize the growing body of evidence on the links between the pandemic and violence against children. Drawing on the World Health Organization's INSPIRE framework to end violence against children, we illustrate how the pandemic is affecting prevention and response efforts. For each of the seven INSPIRE strategies we identify how responses to the pandemic have changed children's risk of violence. We offer ideas for how governments, policy-makers, and international and civil society organizations can address violence in the context of a protracted COVID-19 crisis. We conclude by highlighting how the current pandemic offers opportunities to improve existing child protection systems to address violence against children. We suggest enhanced multisectoral coordination across the health, education, law enforcement, housing, child and social protection sectors. Actions need to prioritize the primary prevention of violence and promote the central role of children and adolescents in decision-making and programme design processes. Finally, we stress the continued need for better data and evidence to inform violence prevention and response strategies that can be effective during and beyond the COVID-19 pandemic.

La pandémie de maladie à coronavirus 2019 (COVID-19) a eu un impact sur le risque de violence à l'égard des enfants à domicile, au sein de leur communauté et en ligne. Elle a également empêché les systèmes de protection de l'enfance d'identifier rapidement les situations de ce type et d'y réagir dès que possible. Pourtant, la nécessité de renforcer les services de prévention et d'action en la matière n'a pas été suffisamment prise en compte dans les stratégies nationales et internationales d'intervention et d'atténuation des effets de la pandémie. Le présent document reprend l'accumulation de preuves confirmant les liens entre pandémie et violence à l'égard des enfants. En nous inspirant du cadre INSPIRE de l'Organisation mondiale de la Santé visant à mettre fin à la violence à l'encontre des enfants, nous illustrons la façon dont la pandémie affecte les efforts de prévention et d'action. Pour chacune des sept stratégies INSPIRE, nous déterminons comment les mesures de lutte contre la pandémie ont influencé le risque de violence envers les enfants. Nous formulons des pistes pour que les gouvernements, les législateurs, les institutions internationales et les organisations de la société civile puissent remédier à cette violence dans un contexte de crise prolongée due à la COVID-19. En guise de conclusion, nous mettons en lumière les opportunités qu'offre la pandémie actuelle d'améliorer les systèmes existants de protection de l'enfance pour mieux combattre la violence envers les enfants. Nous suggérons d'accroître la collaboration entre les secteurs de la santé, de l'éducation, du maintien de l'ordre, du logement, des droits de l'enfant et de la protection sociale. Les actions entreprises doivent se focaliser sur la prévention primaire de la violence et promouvoir le rôle central des enfants et adolescents dans les processus de conception de programmes et de prise de décisions. Enfin, nous soulignons le besoin permanent de données et de preuves fiables pour orienter les stratégies de prévention et d'intervention face à la violence, afin de garantir leur efficacité pendant et après la pandémie de COVID-19.

La pandemia de la enfermedad por coronavirus (COVID-19) ha afectado al riesgo de violencia infantil que sufren los niños en sus hogares, comunidades y en línea, y ha puesto en peligro la capacidad de los sistemas de protección infantil para detectar y responder rápidamente a los casos de violencia. Sin embargo, la necesidad de reforzar los servicios de prevención y respuesta a la violencia no ha recibido suficiente atención en las estrategias nacionales y mundiales de respuesta y mitigación de la pandemia. En este documento, resumimos el creciente conjunto de pruebas sobre los vínculos entre la pandemia y la violencia infantil. Basándonos en el marco INSPIRE de la Organización Mundial de la Salud para poner fin a la violencia infantil, ilustramos cómo la pandemia está afectando a los esfuerzos de prevención y respuesta. Para cada una de las siete estrategias de INSPIRE, identificamos cómo las respuestas a la pandemia han cambiado el riesgo de violencia infantil. Ofrecemos ideas sobre cómo los gobiernos, los responsables políticos y las organizaciones internacionales y de la sociedad civil pueden abordar la violencia en el contexto de una crisis prolongada de COVID-19. Concluimos destacando cómo la pandemia actual ofrece oportunidades para mejorar los sistemas de protección infantil existentes para abordar este tipo de violencia. Sugerimos una mayor coordinación multisectorial en los sectores de la salud, la educación, la aplicación de la ley, la vivienda y la protección social infantil. Las acciones deben priorizar la prevención primaria de la violencia y promover el papel central de los niños y adolescentes en los procesos de toma de decisiones y en el diseño de programas. Por último, subrayamos la necesidad permanente de contar con mejores datos y pruebas para fundamentar las estrategias de prevención y respuesta a la violencia que puedan ser eficaces durante la pandemia de COVID-19 y seguir vigentes cuando ésta pase.

Trust and transparency in times of crisis: Results from an online survey during the first wave (April 2020) of the COVID-19 epidemic in the UK.

BACKGROUND: The success of a government's COVID-19 control strategy relies on public trust and broad acceptance of response measures. We investigated public perceptions of the UK government's COVID-19 response, focusing on the relationship between trust and perceived transparency, during the first wave (April 2020) of the COVID-19 pandemic in the United Kingdom. METHODS: Anonymous survey data were collected (2020-04-06 to 2020-04-22) from 9,322 respondents, aged 20+ using an online questionnaire shared primarily through Facebook. We took an embedded-mixed-methods approach to data analysis. Missing data were imputed via multiple imputation. Binomial & multinomial logistic regression were used to detect associations between demographic characteristics and perceptions or opinions of the UK government's response to COVID-19. Structural topic modelling (STM), qualitative thematic coding of sub-sets of responses were then used to perform a thematic analysis of topics that were of interest to key demographic groups. RESULTS: Most respondents (95.1%) supported government enforcement of behaviour change. While 52.1% of respondents thought the government was making good decisions, differences were apparent across demographic groups, for example respondents from Scotland had lower odds of responding positively than respondents in London. Higher educational levels saw decreasing odds of having a positive opinion of the government response and decreasing household income associated with decreasing positive opinion. Of respondents who thought the government was not making good decisions 60% believed the economy was being prioritised over people and their health. Positive views on government decision-making were associated with positive views on government transparency about the COVID-19 response. Qualitative analysis about perceptions of government transparency highlighted five key themes: (1) the justification of opacity due to the condition of crisis, (2) generalised mistrust of politics, (3) concerns about the role of scientific evidence, (4) quality of government communication and (5) questions about political decision-making processes. CONCLUSION: Our study suggests that trust is not homogenous across communities, and that generalised mistrust, concerns about the transparent use and communication of evidence and insights into decision-making processes can affect perceptions of the government's pandemic response. We recommend targeted community engagement, tailored to the experiences of different groups and a new focus on accountability and openness around how decisions are made in the response to the UK COVID-19 pandemic.

Behavioral Change Towards Reduced Intensity Physical Activity Is Disproportionately Prevalent Among Adults With Serious Health Issues or Self-Perception of High Risk During the UK COVID-19 Lockdown.

Objectives: We assessed whether lockdown had a disproportionate impact on physical activity behavior in groups who were, or who perceived themselves to be, at heightened risk from COVID-19. Methods: Physical activity intensity (none, mild, moderate, or vigorous) before and during the UK COVID-19 lockdown was self-reported by 9,190 adults between 2020-04-06 and 2020-04-22. Physician-diagnosed health conditions and topic composition of open-ended text on participants' coping strategies were tested for associations with changes in physical activity. Results: Most (63.9%) participants maintained their normal physical activity intensity during lockdown, 25.0% changed toward less intensive activity and 11.1% were doing more. Doing less intensive physical activity was associated with obesity (OR 1.25, 95% CI 1.08-1.42), hypertension (OR 1.25, 1.10-1.40), lung disease (OR 1.23, 1.08-1.38), depression (OR 2.05, 1.89-2.21), and disability (OR 2.13, 1.87-2.39). Being female (OR 1.25, 1.12-1.38), living alone (OR 1.20, 1.05-1.34), or without access to a garden (OR 1.74, 1.56-1.91) were also associated with doing less intensive physical activity, but being in the highest income group (OR 1.73, 1.37-2.09) or having school-age children (OR 1.29, 1.10-1.49) were associated with doing more. Younger adults were more likely to change their PA behavior compared to older adults. Structural topic modeling of narratives on coping strategies revealed associations between changes in physical activity and perceptions of personal or familial risks at work or at home. Conclusions: Policies on maintaining or improving physical activity intensity during lockdowns should consider (1) vulnerable groups of adults including those with chronic diseases or self-perceptions of being at risk and (2) the importance of access to green or open spaces in which to exercise.

Modelling the pandemic: attuning models to their contexts.

The evidence produced in mathematical models plays a key role in shaping policy decisions in pandemics. A key question is therefore how well pandemic models relate to their implementation contexts. Drawing on the cases of Ebola and influenza, we map how sociological and anthropological research contributes in the modelling of pandemics to consider lessons for COVID-19. We show how models detach from their implementation contexts through their connections with global narratives of pandemic response, and how sociological and anthropological research can help to locate models differently. This potentiates multiple models of pandemic response attuned to their emerging situations in an iterative and adaptive science. We propose a more open approach to the modelling of pandemics which envisages the model as an intervention of deliberation in situations of evolving uncertainty. This challenges the 'business-as-usual' of evidence-based approaches in global health by accentuating all science, within and beyond pandemics, as 'emergent' and 'adaptive'.

The Importance of Developing Rigorous Social Science Methods for Community Engagement and Behavior Change During Outbreak Response

Despite growing international attention, the anthropological and socio-behavioral elements of epidemics continue to be understudied and under resourced and lag behind the traditional outbreak response infrastructure. As seen in the current 2019 coronavirus disease (COVID-19) pandemic, the importance of socio-behavioral elements in understanding transmission and facilitating control of many outbreak-prone pathogens, this is problematic. Beyond the recent strengthening of global outbreak response capacities and global health security measures, a greater focus on the socio-behavioral components of outbreak response is required. We add to the current discussion by briefly highlighting the importance of socio-behavior in the Ebola virus disease (EVD) response, and describe vital areas of future development, including methods for community engagement and validated frameworks for behavioral modeling and change in outbreak settings.