Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic.
Document Type
Article
Publication Date
6-2021
Identifier
DOI: 10.1016/j.clinthera.2021.04.010; PMCID: PMC8141907
Abstract
Young children will ultimately need to be vaccinated to stop the spread of coronavirus disease 2019 (COVID-19). Initial studies of vaccine were performed in adults. Randomized controlled trials are the gold standard. In the COVID-19 pandemic, many questions need to be answered about the ethics and feasibility of these trials. Given the harms of the COVID-19 pandemic and the now-known efficacy of the vaccines in adults and teens, the question of whether clinical equipoise exists for a placebo-controlled trial of vaccines in younger children remains. Parents may be reluctant to enroll children in these trials because they want their child to receive the vaccine or because they are worried about vaccines or clinical trials in general. One option for gathering data on tolerability and efficacy in children would be to use a nonrandomized trial to enroll parents willing to vaccinate their children and those who are hesitant. We discuss the advantages and disadvantages of such an open-label trial that could provide guidance for future pandemics. (Clin Ther.
Journal Title
Clinical therapeutics
Volume
43
Issue
6
First Page
163
Last Page
172
Keywords
COVID-19; Ethics; Vaccines; children; clinical trials; safety
Recommended Citation
Wolfe ID, Patel A, Kociolek LK, Fazal A, Jhaveri R, Lantos JD. Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic. Clin Ther. 2021;43(6):e163-e172. doi:10.1016/j.clinthera.2021.04.010
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