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. 2023 Dec 15;19(3):2272535.
doi: 10.1080/21645515.2023.2272535. Epub 2023 Nov 9.

"Direct and indirect impacts of the COVID-19 pandemic on operational conduct of pediatric vaccine clinical trials"

Monica Anne McArthur  1 , Siham Bchir  2 , Estelle Dubois  3 , Lucia Gan  4 , Eric Gerchman  5 , Sandeep Gupta  1 , Olga Liabis  6 , Lucia Perez  5 , Fabienne Roche  3 , Gustavo Vasquez  1 , Betzana Zambrano  7 , Sanjay Gurunathan  1 , Mandeep Singh Dhingra  1
Affiliations

"Direct and indirect impacts of the COVID-19 pandemic on operational conduct of pediatric vaccine clinical trials"

Monica Anne McArthur et al. Hum Vaccin Immunother. .

Abstract

The 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.

Keywords: COVID-19; Vaccines; clinical trials operations; operational disruption; pediatric vaccine trials.

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Conflict of interest statement

No additional potential conflcit of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Overview of COVID impact on endpoints by Quarter. See Table 2 for dates of quarters (a) percentage of participants diagnosed with COVID-19 (b) percentage of early terminations due to COVID-19 out of total trial early terminations (c) percentage of visits not done due to COVID-19 (d) percentage of visits only partially done due to COVID-19 (e) percentage of participants with at least 1 procedure out of window.
Figure 2.
Figure 2.
Pre- and post-COVID operations by region. Green = pre-COVID-19 pandemic, purple = during COVID-19 pandemic. X represents rate, boxes are 95% confidence intervals. (a, e, i, & m) rate of blood draws out of protocol-defined window. (b, f, j, & n) rate of vaccinations skipped. (c, g, k, & o) rate of vaccinations given outside of protocol-defined window. (d, h, l, & p) rate of trial visits canceled or delayed. Regions: United States (US – includes Puerto Rico) A-D. European Union (EU – includes Czech Republic, Finland, Italy, Poland, Romania, Spain, & Sweden) E-H. United Kingdom (UK) I-L. Other (includes Russia & Mexico) M-P.
Figure 3.
Figure 3.
Investigational and routine vaccinations skipped by quarter pre-pandemic and during the pandemic. (a) Trial 1, (b) Trial 2, (c) Trial 3, (d) Trial 4, (e) Trial 5, (f) Trial 6.
Figure 4.
Figure 4.
Effects of UK lockdowns on protocol deviations in study 5. (a) timeline of COVID-19 pandemic lockdown measures in the UK. (b) number of participants enrolled through the end of enrollment 31Dec2021. (c) percentage of blood draws out of window. (d) percentage of vaccinations skipped. (e) percentage of vaccinations out of window. (f) percentage of visits canceled or out of window. Yellow line = start of COVID-19 pandemic shaded red boxes = COVID-19 lockdowns in UK.
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