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Pediatrics ; 147(3)2021 03.
Article in English | MEDLINE | ID: covidwho-992774

ABSTRACT

It is widely agreed that an effective response to the coronavirus disease 2019 pandemic needs to include a vaccine that is safe and effective for minors. However, many current vaccine trials have no plans for when to enroll minors. Others have recently proposed enrolling minors as young as 12 years old. This lack of a systematic approach raises 2 concerns. Waiting too long to enroll minors could unjustly deny minors and their families the benefits of a vaccine and has the potential to delay an effective response to the pandemic by a year or longer. At the same time, enrolling minors too soon runs the risk of exposing them to excessive risks. With these concerns in mind, in the present article, we propose recommendations for when and how to enroll minors in vaccine trials for the coronavirus disease 2019.


Subject(s)
COVID-19 Vaccines , Clinical Trials as Topic/standards , Healthy Volunteers , Minors , Adolescent , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Child , Clinical Trials as Topic/ethics , Community Participation , Ethics Committees, Research , Humans , Informed Consent By Minors , Pandemics/prevention & control , SARS-CoV-2
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