Vaccine trials during a pandemic: potential approaches to ethical dilemmas
Citation:
Alqahtani, M. and Mallah, S.I. and Stevenson, N. and Doherty, S., Vaccine trials during a pandemic: potential approaches to ethical dilemmas, Trials, 2021, 22, 1Download Item:
Abstract:
Ever since the emergence of the coronavirus disease 2019 (COVID-19), global public health infrastructures and
systems, along with community-wide collaboration and service, have risen to an unprecedented challenge. Vaccine
development was immediately propelled to the centre of all our scientific, public health and community efforts.
Despite the development of SARS-CoV-2 vaccines arguably being the greatest and most palpable achievements of
the past 12 months, they have also been one of the most contentious and debated issues during the pandemic.
However, what uniquely differentiates vaccine development is its intimate relationship with the community it seeks
to serve; both in its clinical trial testing as an efficacious and safe prophylactic, and its post-developmental ‘roll-out’
success, as an effective public health tool. These relationships have birthed a myriad of complexities, from
community-based mistrust, to academically contended ethical dilemmas. Indeed, the accelerated advances in the
COVID-19 vaccine race have further exacerbated this phenomenon, bringing with it new ethical dilemmas that
need to be examined to ensure the continued clinical success of these therapeutics and a renewed societal trust in
clinical medicine.
In this paper, we discuss two major ethical dilemmas: (1) the equipoise of continuing new vaccine trials in the
advent of successful candidates and (2) the maleficence of blinded placebo arms. Accordingly, we discuss six
different potential approaches to these ethical dilemmas: (1) continuing with placebo-controlled trials, (2)
transitioning from placebo-controlled to open-label, (3) unblinding at-risk priority groups only, (4) transitioning to a
blinded stepped-wedge cross-over design, (5) progressing to a blinded active-controlled stepped-wedge cross-over
trial, and (6) conducting randomised stepped-wedge community trials. We also propose a decision-making
algorithm for relevant stakeholders in advanced stages of vaccine trials.
It is important to remember that the emergent nature of the COVID-19 situation does not justify a compromise on
core ethical values. In fact, the discourse surrounding this topic and the decisions made will remain a potent case
study and a continuously referenced example for all such future scenarios
Author's Homepage:
http://people.tcd.ie/stevennj
Author: Stevenson, Nigel
Type of material:
Journal ArticleCollections
Series/Report no:
Trials;22;
1;
Availability:
Full text availableKeywords:
coronavirus disease 2019 (COVID-19),, Vaccine development, public health tool, COVID-19, Medical ethics, Pandemic, Vaccines, Clinical trialsDOI:
http://dx.doi.org/10.1186/s13063-021-05597-8Metadata
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