Exploration and Ethical Analysis of Open-label Pediatric Vaccine Trials in a Pandemic.
Clin Ther
; 43(6): e163-e172, 2021 06.
Artículo
en Inglés
| 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.
Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Pandemias
/
Vacunas contra la COVID-19
/
COVID-19
Tipo de estudio:
Estudio experimental
/
Estudio observacional
/
Estudio pronóstico
/
Ensayo controlado aleatorizado
Tópicos:
Vacunas
Límite:
Niño
/
Child, preschool
/
Humanos
Idioma:
Inglés
Revista:
Clin Ther
Año:
2021
Tipo del documento:
Artículo
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