Placebo control group in COVID-19 vaccine trials: context and timing matters

Dal‐Ré, Rafael

doi:10.1007/s00228-021-03259-x

Cited by 3 publications

(1 citation statement)

References 17 publications

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“…49 When trials for COVID-19 vaccines first started, a state of clinical equipoise existed, as the therapeutic validity of the intervention under study had yet to be ascertained 50 ; therefore, investigators could randomly assign participants to a placebo or intervention group. Since the first vaccine was found to be safe and efficacious, though, in countries where such temporarily authorized vaccine was available (such as European ones), 51 placebo-controlled trials could no longer be considered acceptable. 52 In response to this challenging ethical issue, the WHO published a policy brief, which stated that: "A candidate vaccine's attainment of emergency use designation does not, in itself, render that candidate the best proven intervention […] Accordingly, the continued use of placebos or active controls in the control arm of current or future trials testing other candidate vaccines […] should not be regarded as violating the Declaration of Helsinki, CIOMS, or WHO's previous guidance."…”

Section: Evaluation Of New Candidate Vaccines: Use Of the Placebo And...mentioning

confidence: 99%

Fast‐tracking development and regulatory approval of COVID‐19 vaccines in the EU: A review of ethical implications

Beretta

Marelli

2023

Bioethics

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The rapid spread of SARS‐CoV‐2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID‐19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the “fast‐tracking” of COVID‐19 vaccine R&D and approval. Second, drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID‐19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll‐out of this key pandemic‐containment technology worldwide.

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Section: Evaluation Of New Candidate Vaccines: Use Of the Placebo And...mentioning

confidence: 99%