RT Journal Article
T1 Off-label prescription of BNT162b2 mRNA COVID-19 vaccine to <5-year-old children in the European Union.
A1 Dal-Re, Rafael
A1 Calvo, Cristina
A1 Neth, Olaf
K1 Off‑label use
K1 Unlicensed use
K1 Paediatric use
K1 BNT162b2 vaccine
K1 Informed consent
K1 Regulatory agency
AB Off-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
PB Wiley-Blackwell Publishing Ltd.
YR 2023
FD 2023-01-09
LK http://hdl.handle.net/10668/19910
UL http://hdl.handle.net/10668/19910
LA en
NO Dal-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.
DS RISalud
RD Aug 4, 2025