Dal-Re, RafaelCalvo, CristinaNeth, Olaf2023-05-032023-05-032023-01-09Dal-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.http://hdl.handle.net/10668/19910Off-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 1enOff‑label useUnlicensed usePaediatric useBNT162b2 vaccineInformed consentRegulatory agencyHumansChild, PreschoolEuropean UnionBNT162 VaccineCOVID-19COVID-19 VaccinesOff-Label Useresearch article35657672Restricted AccessUso fuera de indicaciónUso sin licenciaUso pediátricoVacuna BNT162b2Consentimiento informadoAgencia reguladora10.1111/apa.164421651-2227PMC9347686https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347686https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9347686/pdf