Pediatric Off-Label Use of Covid-19 Vaccines: Ethical and Legal Considerations.
Covid-19
children
equity
off-label use
vaccination
Journal
The Hastings Center report
ISSN: 1552-146X
Titre abrégé: Hastings Cent Rep
Pays: United States
ID NLM: 0410447
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
pubmed:
10
11
2021
medline:
22
12
2021
entrez:
9
11
2021
Statut:
ppublish
Résumé
When the U.S. Food and Drug Administration fully approved the Pfizer-BioNTech Covid-19 vaccine for people sixteen and older, questions arose. Parents, pediatricians, and the media wondered whether Covid-19 vaccines could be used off-label-and whether they should be. The American Academy of Pediatrics cautioned against pediatric off-label use of the vaccine, and the vaccine provider agreement from the Centers for Disease Control and Prevention appears to prohibit it. After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of a blanket prohibition on off-label pediatric Covid-19 vaccination, as it limits clinician ability to provide care they may determine to be clinically and ethically appropriate. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.
Identifiants
pubmed: 34750807
doi: 10.1002/hast.1296
pmc: PMC8653287
doi:
Substances chimiques
COVID-19 Vaccines
0
BNT162 Vaccine
N38TVC63NU
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
27-32Informations de copyright
© 2021 The Hastings Center.
Références
J Am Acad Psychiatry Law. 2021 Mar;49(1):53-59
pubmed: 33234538
Pharmacoepidemiol Drug Saf. 2011 Sep;20(9):895-902
pubmed: 21774029
BMJ Open. 2016 Aug 31;6(8):e012803
pubmed: 27580838
New Sci. 2021 Feb 27;249(3323):10-11
pubmed: 33686318
Rev Obstet Gynecol. 2011 Summer;4(2):39-41
pubmed: 22102925
Nephrol News Issues. 2007 Jun;21(7):43-4, 46-7
pubmed: 17623984
Mayo Clin Proc. 2012 Oct;87(10):982-90
pubmed: 22877654
Hastings Cent Rep. 2021 Nov;51(6):27-32
pubmed: 34750807
Arch Pediatr Adolesc Med. 2007 Mar;161(3):282-90
pubmed: 17339510
Acad Pediatr. 2009 Mar-Apr;9(2):81-8
pubmed: 19329098
Clin Pharmacol Ther. 2020 Aug;108(2):182-184
pubmed: 32311763
Ann Intern Med. 2009 Mar 3;150(5):344-7
pubmed: 19221367
Hosp Pediatr. 2019 Mar;9(3):186-193
pubmed: 30745323