Off-label use of vaccines

Pieter Neels, James Southern, Jon Abramson, Philippe Duclos, Joachim Hombach, Melanie Marti, Alanna Fitzgerald-Husek, Jacqueline Fournier-Caruana, Germaine Hanquet

Résultats de recherche: Recherche - Revue par des pairsArticle de revue

Résumé

This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or “label” 1 Label: The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article. This includes the Summary of the approved Product Characteristics (SmPC) and Package Insert.1), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product label regarding the vaccine use can lead to confusion at the level of vaccinators and vaccinees and possibly result in lower compliance with national vaccination schedules. In particular, in many countries, the label may contain regulatory restrictions and warnings against vaccination of specific population groups (e.g. pregnant women) due to a lack of evidence of safety from controlled trials at the time of initial licensure of the vaccine, while public health authorities may recommend the same vaccine for that group, based on additional post-marketing data and benefit risk analyses. We provide an overview of the different responsibilities between regulatory authorities and public health advisory bodies, and the rationale for off-label use 2 Off-label use: Any use of an authorised product not covered by the terms of its marketing authorisation and therefore not in accordance with the SmPC, labelling.2 of vaccines, the challenges involved based on the impact of off-label use in real-life. We propose to reduce off-label use of vaccines by requiring the manufacturer to regularly adapt the label as much as possible to the public health needs as supported by new evidence. This would require manufacturers to collect and report post-marketing data, communicate them to all stakeholders and regulators to extrapolate existing evidence (when acceptable) to other groups or to other brands of a vaccine (class effect 3 Class effect: An effect for a group of drugs with similar chemical structure and/or drugs with similar mechanism of action and/or drugs with similar pharmacological effects.3). Regulatory authorities have a key role to play by requesting additional post-marketing data, e.g. in specific target groups. When public health recommendations for vaccine use that are outside labelled indications are considered necessary, good communication between regulatory bodies, public health authorities, companies and health care providers or vaccinators is crucial. Recommendations as well as labels and label changes should be evidence-based. The rationale for the discrepancy and the recommended off-label use of a vaccine should be communicated to providers.

langueAnglais
Pages2329-2337
Nombre de pages9
journalVaccine
Volume35
Numéro18
Les DOIs
étatPublié - 25 avr. 2017

Empreinte digitale

Off-Label Use
Vaccines
vaccines
Public Health
public health
Marketing
marketing
Pharmaceutical Preparations
drugs
Product Labeling
Vaccination
vaccination
Licensure
Population Groups
Health Personnel
Pregnant Women
Appointments and Schedules
Communication
Pharmacology
Safety

mots-clés

    Citer ceci

    Neels, P., Southern, J., Abramson, J., Duclos, P., Hombach, J., Marti, M., ... Hanquet, G. (2017). Off-label use of vaccines. Vaccine, 35(18), 2329-2337. DOI: 10.1016/j.vaccine.2017.02.056
    Neels, Pieter ; Southern, James ; Abramson, Jon ; Duclos, Philippe ; Hombach, Joachim ; Marti, Melanie ; Fitzgerald-Husek, Alanna ; Fournier-Caruana, Jacqueline ; Hanquet, Germaine. / Off-label use of vaccines. Dans: Vaccine. 2017 ; Vol 35, Numéro 18. p. 2329-2337
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    Neels, P, Southern, J, Abramson, J, Duclos, P, Hombach, J, Marti, M, Fitzgerald-Husek, A, Fournier-Caruana, J & Hanquet, G 2017, 'Off-label use of vaccines' Vaccine, VOL 35, Numéro 18, p. 2329-2337. DOI: 10.1016/j.vaccine.2017.02.056

    Off-label use of vaccines. / Neels, Pieter; Southern, James; Abramson, Jon; Duclos, Philippe; Hombach, Joachim; Marti, Melanie; Fitzgerald-Husek, Alanna; Fournier-Caruana, Jacqueline; Hanquet, Germaine.

    Dans: Vaccine, Vol 35, Numéro 18, 25.04.2017, p. 2329-2337.

    Résultats de recherche: Recherche - Revue par des pairsArticle de revue

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    Neels P, Southern J, Abramson J, Duclos P, Hombach J, Marti M et al. Off-label use of vaccines. Vaccine. 2017 avr. 25;35(18):2329-2337. Disponible à, DOI: 10.1016/j.vaccine.2017.02.056