Pandemic vaccine trials: expedite, but don’t rush

Dawson, Angus

doi:10.1177/1747016120943730

Cited by 4 publications

(4 citation statements)

References 17 publications

(21 reference statements)

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“…However, SARS-CoV-2 vaccine risks are likely to be less clear than for many vaccines. This is both because vaccine development is being fasttracked [21] and because trial participants report uncomfortable side effects [22]. Counterbalancing this, the benefits of immunity may also be increased by permitting greater social and economic participation.…”

Section: Ensuring Societal Benefitmentioning

confidence: 99%

How should we conduct pandemic vaccination?

Williams

Degeling

McVernon

et al. 2021

Vaccine

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Vaccination plays an important role in pandemic planning and response. The possibility of developing an effective vaccine for a novel pandemic virus is not assured. However, as we have seen with SARS-CoV-2 vaccine development, with sufficient resources and global focus, successful outcomes can be achieved in a relatively short period. However even when vaccine is available it will initially be scarce. When one becomes available, how should it be distributed?In this paper we explicate how ethical thinking that is carefully attuned to context is essential to decisions about how we should conduct vaccination in a pandemic where demand exceeds supply. We focus on two key issues. First, setting the aims for a pandemic vaccination programme. Second, thinking about the means of delivering a chosen aim. We outline how pandemic vaccine distribution strategies can be implemented with distinct aims, e.g. protecting groups at greater risk of harm, saving the most lives, or ensuring societal benefit. Each aim will result in a focus on a different priority population and each strategy will have a different benefit-harm profile. Once we have decided our aim, we still have choices to make about delivery. We may achieve at least some ends via direct or indirect strategies. Such policy decisions are not merely technical, but necessarily involve ethics. One important general issue is that such planning decisions about distribution will always be made under conditions of uncertainty about vaccine safety and effectiveness. However, planning how to distribute vaccine for SARS-CoV-2 is even harder because we understand relatively little about the virus, transmission, and its immunological impact in the short and long term.

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Section: Ensuring Societal Benefitmentioning

confidence: 99%

How should we conduct pandemic vaccination?

Williams

Degeling

McVernon

et al. 2021

Vaccine

Self Cite

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show abstract

“…Moreover, while these extraordinary times might require extraordinary actions, care must be taken to avoid shortcuts that may have serious consequences beyond those for volunteers. As Dawson (2020) highlights, there are sound ethical and scientific reasons for why vaccine studies proceed through certain phases, which also contribute to trust-building.…”

Section: Carementioning

confidence: 99%

Ethical research in the COVID-19 era demands care, solidarity and trustworthiness

Chatfield¹,

Schroeder²

2020

Research Ethics

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What can academics do during a lockdown situation to contribute to the fight against COVID-19? They can reflect upon COVID-19 challenges in their areas of expertise and provide suggestions for difficult dilemmas. That is what the 11 authors who contributed to this special issue did. Working to tight deadlines, they drafted manuscripts related to COVID-19 research ethics, responded graciously and with flexibility to the expedited double review and submitted their final versions at double speed. For some this meant late evening work after online meetings on various COVID-19 committees. For others it meant an additional workload in their already full schedules. We are very grateful to each of the 11 authors for their generosity of spirit. We hope that this special issue will be as valuable to readers as it is valuable to us. Compelling messages emerge from this collection about how to ensure that COVID-19 research is ethical. These include the pressing need for care, solidarity and trustworthiness. Care While many have assumed a less active life during lockdown, 30,000 healthy people from 140 countries registered their interest to enrol in vaccine studies within unknown risks (Chappell and Singer, 2020 1). Motivations for taking part in vaccine research vary widely. On the one hand, in resource-poor settings, 'financial incentives and access to health care are a major driver for enrolment in studies' (Mduluza et al., 2013; Mfutso-Bengo et al., 2008). On the other hand, preliminary results from a study undertaken in Canada (in relation to an Ebola vaccine) suggest that, in high-income settings, participant motivations include the desire to help develop a new vaccine, and the desire to help others (Tangwa et al., 2018).

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“…However, the number of COVID-19 deaths may be underestimated, based on excess death numbers recorded by the South African Medical Research Council [ 2 ]. The initial absence of effective treatments or vaccines resulted in drastic public health measures, including national lockdowns, social distancing and contact tracing, to reduce transmission [ 3 ]. These measures caused significant socio-economic disruption, particularly on the African continent [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees

2023

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Background The COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa. Methods We conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data. Results Five main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme. Conclusions Numerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues.

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Pandemic vaccine trials: expedite, but don’t rush

Cited by 4 publications

References 17 publications

How should we conduct pandemic vaccination?

How should we conduct pandemic vaccination?

Ethical research in the COVID-19 era demands care, solidarity and trustworthiness

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees

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