The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants.
Indian J Med Ethics
; VI(2): 1-10, 2021.
Article
in English
| MEDLINE | ID: covidwho-1206590
ABSTRACT
Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Placebos
/
Guidelines as Topic
/
Biomedical Research
/
Patient Safety
/
COVID-19 Vaccines
/
COVID-19
/
Human Rights
Type of study:
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
Indian J Med Ethics
Journal subject:
Ethics
Year:
2021
Document Type:
Article
Affiliation country:
IJME.2021.020
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