학술논문

'Direct and indirect impacts of the COVID-19 pandemic on operational conduct of pediatric vaccine clinical trials'
Document Type
article
Source
Human Vaccines & Immunotherapeutics, Vol 19, Iss 3 (2023)
Subject
Vaccines
clinical trials operations
pediatric vaccine trials
COVID-19
operational disruption
Immunologic diseases. Allergy
RC581-607
Therapeutics. Pharmacology
RM1-950
Language
English
ISSN
21645515
2164-554X
2164-5515
Abstract
ABSTRACTThe coronavirus 2019 (COVID-19) pandemic, as well as the resulting public health measures, impacted many aspects of society. The conduct of important pediatric vaccine trials was among these. Analyzing data from six ongoing non-COVID-19 pediatric vaccine trials we aimed to assess the operational impact of the COVID-19 pandemic using descriptive analyses. We identified multiple operational disruptions in trial conduct. Additionally, we identified higher percentages of missed routine vaccinations than investigational vaccines throughout the observation period. Overall, the impact of the COVID-19 pandemic was most apparent early in the pandemic period while adaptations to the pandemic were developed; however, some disruptions persisted throughout the observation period. Pediatric vaccine clinical trials are critical to developing new and/or improved vaccines for the pediatric population. Continued evaluation of the impacts of COVID-19 on pediatric vaccine clinical trials is warranted.