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Problematic Covid-19 vaccine trials in times of vaccine nationalism

Raffaella Ravinetto1

  • 1Department of Public Health, Institute of Tropical Medicine, Antwerp, BELGIUM.

Indian Journal of Medical Ethics
|April 28, 2021
PubMed

Insights

Ethical COVID-19 vaccine trials can use placebos in regions with limited access, provided participants are ineligible for vaccination and global allocation is just. Unethical global vaccine distribution makes placebo-controlled trials in such areas unacceptable.

Area of Science:

  • Medical Ethics
  • Vaccinology
  • Global Health

Background:

  • Several COVID-19 vaccines have received conditional approval, with many more undergoing evaluation.
  • Ongoing clinical trials are crucial for continued vaccine assessment.
  • The World Health Organization (WHO) has provided ethical guidelines for vaccine trials in diverse access settings.

Purpose of the Study:

  • To evaluate the ethical considerations of using placebo-controlled trials for COVID-19 vaccines.
  • To determine conditions under which placebo-controlled trials are ethically permissible, particularly in resource-limited settings.

Main Methods:

  • Ethical analysis of clinical trial design in the context of global vaccine access.
  • Review of WHO recommendations and ethical principles for human subjects research.
  • Argumentative reasoning based on principles of justice and equitable allocation.

Main Results:

  • Placebo-controlled trials are ethically acceptable if participants are ineligible for vaccination outside the trial.
  • Ethical permissibility is contingent upon a just and transparent framework for vaccine allocation outside the trial.
  • Conducting such trials in regions with inequitable vaccine access due to global disparities is deemed unethical.

Conclusions:

  • Ethical frameworks must address global vaccine inequity when considering placebo-controlled trials.
  • The premise of equitable access is fundamental to the ethical justification of placebo-controlled vaccine studies in any setting.
  • A just global allocation strategy is a prerequisite for the ethical implementation of COVID-19 vaccine trials in regions with limited access.

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