Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic

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 . 2021;XX:XXX–XXX) © 2021 Elsevier HS Journals, Inc.

Ethical and scientific complexity in debates about COVID vaccination in children

“…Differing parental attitudes could represent an opportunity to do an open-label, non-randomised prospective trial to refine estimates of vaccine efficacy. 10 The variable professional recommendations and public attitudes lead to the following conclusions about where we are and where we are going. Science can guide us in deciding whether COVID vaccine for children is safe enough and effective enough, even with the limitations stated in this article.…”

“…Differing parental attitudes could represent an opportunity to do an open‐label, non‐randomised prospective trial to refine estimates of vaccine efficacy. 10 …”

“…But the opposite would potentially apply in communities where there are still large numbers of non‐immune and vulnerable older adults. Differing parental attitudes could represent an opportunity to do an open‐label, non‐randomised prospective trial to refine estimates of vaccine efficacy 10 …”