Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic.
Clin Ther
; 43(6): e163-e172, 2021 06.
Article
in English
| MEDLINE | ID: covidwho-1240250
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Pandemics
/
COVID-19 Vaccines
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Child
/
Child, preschool
/
Humans
Language:
English
Journal:
Clin Ther
Year:
2021
Document Type:
Article
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