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

Abstract

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