Publication:
Off-label prescription of BNT162b2 mRNA COVID-19 vaccine to <5-year-old children in the European Union.

dc.contributor.authorDal-Re, Rafael
dc.contributor.authorCalvo, Cristina
dc.contributor.authorNeth, Olaf
dc.date.accessioned2023-05-03T13:28:30Z
dc.date.available2023-05-03T13:28:30Z
dc.date.issued2023-01-09
dc.description.abstractOff-label or unlicensed use of medicinal products are those that are prescribed outside the terms of their authorisation by the regulatory agency in a given jurisdiction i e unapproved indication age group posology route or schedule of administration As the highly transmissible Omicron variant of SARS-CoV-2 becomes prevalent in the US the EU and elsewhere Pfizer BioNTech announced that the results of the ongoing phase 2 3 trial NCT04816643 assessing its BNT162b2 mRNA vaccine in 0 5 4-year-old children will be delayed to test a 3- dose regimen A debate has emerged in the USA on whether this vaccine could be ethically prescribed to this age group of children Whilst some commentators considered its prescription to be ethically acceptable in vulnerable kids at high risk of developing severe COVID-19 1 2 recommendation against off-label paediatric use has been issued by the US Food and Drug Administration American Academy of Paediatrics and Centers for Disease Control and Prevention In addition this latter has warned that off-label vaccine 5-year-old recipients may not be eligible for federal compensation in case of adverse events 1
dc.description.versionSi
dc.identifier.citationDal-Ré R, Calvo C, Neth O. Off-label prescription of BNT162b2 mRNA COVID-19 vaccine to <5-year-old children in the European Union. Acta Paediatr. 2023 Feb;112(2):183-185.
dc.identifier.doi10.1111/apa.16442
dc.identifier.essn1651-2227
dc.identifier.pmcPMC9347686
dc.identifier.pmid35657672
dc.identifier.pubmedURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347686/pdf
dc.identifier.unpaywallURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347686
dc.identifier.urihttp://hdl.handle.net/10668/19910
dc.issue.number2
dc.journal.titleActa paediatrica (Oslo, Norway : 1992)
dc.journal.titleabbreviationActa Paediatr
dc.language.isoen
dc.organizationHospital Universitario Virgen del Rocío
dc.organizationInstituto de Biomedicina de Sevilla-IBIS
dc.page.number183-185
dc.provenanceRealizada la curación de contenido 23/06/2025.
dc.publisherWiley-Blackwell Publishing Ltd.
dc.pubmedtypeJournal Article
dc.relation.publisherversionhttps://doi.org/10.1111/apa.16442
dc.rights.accessRightsRestricted Access
dc.subjectOff‑label use
dc.subjectUnlicensed use
dc.subjectPaediatric use
dc.subjectBNT162b2 vaccine
dc.subjectInformed consent
dc.subjectRegulatory agency
dc.subject.decsUso fuera de indicación
dc.subject.decsUso sin licencia
dc.subject.decsUso pediátrico
dc.subject.decsVacuna BNT162b2
dc.subject.decsConsentimiento informado
dc.subject.decsAgencia reguladora
dc.subject.meshHumans
dc.subject.meshChild, Preschool
dc.subject.meshEuropean Union
dc.subject.meshBNT162 Vaccine
dc.subject.meshCOVID-19
dc.subject.meshCOVID-19 Vaccines
dc.subject.meshOff-Label Use
dc.titleOff-label prescription of BNT162b2 mRNA COVID-19 vaccine to <5-year-old children in the European Union.
dc.typeresearch article
dc.type.hasVersionVoR
dc.volume.number112
dspace.entity.typePublication

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