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Why Challenge Trials of SARS-CoV-2 Vaccines Could Be Ethical Despite Risk of Severe Adverse Events

Nir Eyal1

  • 1Directs the Center for Population-Level Bioethics at Rutgers University and is the Henry Rutgers professor of bioethics in the Department of Health Behavior, Society and Policy at Rutgers School of Public Health and in the Department of Philosophy at Rutgers's School of Arts and Sciences.

Ethics & Human Research
|May 23, 2020
PubMed

Insights

Human challenge trials for SARS-CoV-2 vaccines are ethical. Comparing them to standard testing, these trials offer a faster, more effective way to save lives during the COVID-19 pandemic.

Area of Science:

  • Infectious Diseases
  • Vaccinology
  • Bioethics

Background:

  • The COVID-19 pandemic necessitated rapid vaccine development against SARS-CoV-2.
  • Human challenge trials (HCTs) involve intentionally exposing volunteers to a pathogen.
  • Ethical concerns often arise regarding HCTs due to volunteer risk without proven treatments.

Purpose of the Study:

  • To evaluate the ethical justification of SARS-CoV-2 vaccine human challenge trials.
  • To propose a comparative ethical framework for assessing HCTs.
  • To argue that HCTs are ethically superior to standard efficacy testing in specific pandemic contexts.

Main Methods:

  • Ethical analysis of human challenge trials versus traditional vaccine efficacy studies.
  • Comparative assessment of risks, benefits, and societal value.
  • Consideration of the unique circumstances presented by the COVID-19 pandemic.

Main Results:

  • Standard ethical tests may initially deem HCTs problematic due to volunteer exposure.
  • A comparative ethical analysis reveals HCTs can be ethically justifiable.
  • In the context of COVID-19, HCTs demonstrate greater ethical merit than standard testing.

Conclusions:

  • Human challenge trials for COVID-19 vaccines are ethically sound when evaluated comparatively.
  • HCTs offer a more efficient pathway for vaccine development, saving time and lives.
  • The specific context of the pandemic strengthens the ethical case for employing HCTs.
Keywords:
Covid-19coronavirushuman challenge studiesrandomized controlled trialsresearch ethicsrisk takingvaccines

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