The European regulatory environment of rna-based vaccines

Thomas Hinz, Kajo Kallen, Cedrik M. Britten, Bruno Flamion, Ulrich Granzer, Axel Hoos, Christoph Huber, Samir Khleif, Sebastian Kreiter, Hans Georg Rammensee, Ugur Sahin, Harpreet Singh-Jasuja, Özlem Türeci, Ulrich Kalinke

Résultats de recherche: Contribution dans un livre/un catalogue/un rapport/dans les actes d'une conférenceChapitre


A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that mRNA-based vaccines in most cases have to be centrally approved. Interestingly, depending on whether RNA-based vaccines are directed against tumors or infectious disease, they are formally considered gene therapy products or not, respectively. Besides an overview on the current clinical use of mRNA vaccines in various therapeutic areas a detailed discussion of the current regulatory situation is provided and regulatory perspectives are discussed.

langue originaleAnglais
titreMethods in Molecular Biology
EditeurHumana Press Inc.
Nombre de pages20
Les DOIs
Etat de la publicationPublié - 2017

Série de publications

NomMethods in Molecular Biology
ISSN (imprimé)10643745

Empreinte digitale

Examiner les sujets de recherche de « The European regulatory environment of rna-based vaccines ». Ensemble, ils forment une empreinte digitale unique.

Contient cette citation