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The Ethics of Human Challenge Trials Using Emerging Severe Acute Respiratory Syndrome 2 Variants

Abie Rohrig1,2, Nir Eyal3

  • 11Day Sooner, New York, USA.

The Journal of Infectious Diseases
|October 8, 2021
PubMed

Insights

Ethical considerations for human challenge trials involving severe acute respiratory syndrome 2 (SARS-CoV-2) variants are explored. The study concludes that such trials, even with concerning variants, can be ethically justified.

Area of Science:

  • Infectious Diseases
  • Bioethics
  • Virology

Background:

  • The first coronavirus disease 2019 (COVID-19) human challenge trial utilized the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2).
  • Preparation for follow-up trials using Beta and Delta variants is funded, with researchers considering their execution.

Purpose of the Study:

  • To examine the ethical justifiability of human challenge trials involving SARS-CoV-2 variants of concern.
  • To address specific variant characteristics that might raise ethical concerns.

Main Methods:

  • Literature review and ethical analysis of human challenge trial protocols.
  • Exploration of specific characteristics of SARS-CoV-2 variants relevant to ethical considerations.

Main Results:

  • Existing literature on the ethics of SARS-CoV-2 variant challenge trials is limited.
  • Two specific variant characteristics, initially perceived as ethically problematic, are analyzed.

Conclusions:

  • SARS-CoV-2 variant challenge trials can be conducted ethically.
  • Ethical frameworks can accommodate the challenges posed by variants of concern in human challenge trials.
Keywords:
COVID-19controlled human infection modelhuman challenge trialsresearch ethicsvaccine ethics

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