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Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure
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COVID-19 vaccine trials with children: ethics pointers.

Caesar Alimisnya Atuire1, Sofía P Salas2, Katharine Wright3

  • 1Department of Philosophy and Classics, University of Ghana, Accra, Ghana atuire.ca@gmail.com.

BMJ Global Health
|January 11, 2022
PubMed
Summary

Ethical considerations are crucial for COVID-19 vaccine trials in children, especially in low-income countries. This includes vaccine relevance, consent, and ancillary care to ensure participant safety and trial integrity.

Keywords:
COVID-19vaccines

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Area of Science:

  • Medical Ethics
  • Pediatric Clinical Trials
  • Global Health

Background:

  • Global vaccination efforts for SARS-CoV-2 (the virus causing COVID-19) now include children.
  • Clinical trials in children are essential for establishing safety, efficacy, and appropriate dosages.
  • Ethical review of pediatric COVID-19 vaccine trials in low- and middle-income countries (LMICs) presents unique challenges.

Purpose of the Study:

  • To identify and address key ethical questions for phase III COVID-19 vaccine trials involving children in resource-limited settings.
  • To provide considerations for ethics committees and policymakers reviewing these trials.

Main Methods:

  • The study outlines critical ethical questions relevant to pediatric COVID-19 vaccine trials.
  • It discusses issues such as vaccine relevance, use of unapproved vaccines in trials, participant selection, informed consent for minors, placebo use, and ancillary care obligations.

Main Results:

  • Key ethical considerations include the relevance of the trial vaccine to the local population.
  • Decisions regarding the use of vaccines not yet approved for adults in pediatric trials require careful ethical scrutiny.
  • Informed consent processes for minors and the provision of ancillary care are critical, particularly in LMICs.

Conclusions:

  • Implementing COVID-19 vaccine trials in children in LMICs necessitates careful ethical deliberation.
  • Addressing specific ethical questions proactively ensures participant welfare and the integrity of research in diverse global settings.