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

Research output: Chapter in Book/Report/Conference proceedingChapter

5 Scopus citations

Abstract

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.

Original languageEnglish (US)
Title of host publicationMethods in Molecular Biology
PublisherHumana Press Inc.
Pages203-222
Number of pages20
DOIs
StatePublished - Jan 1 2017

Publication series

NameMethods in Molecular Biology
Volume1499
ISSN (Print)1064-3745

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Keywords

  • Advanced therapy medicinal products (ATMP)
  • Anticancer vaccination
  • Genetically modified medicinal products
  • Preventive and therapeutic approaches
  • Regulatory framework in the EU
  • Vaccination against infectious disease
  • Vaccines
  • mRNA

ASJC Scopus subject areas

  • Molecular Biology
  • Genetics

Cite this

Hinz, T., Kallen, K., Britten, C. M., Flamion, B., Granzer, U., Hoos, A., Huber, C., Khleif, S., Kreiter, S., Rammensee, H. G., Sahin, U., Singh-Jasuja, H., Türeci, Ö., & Kalinke, U. (2017). The European regulatory environment of rna-based vaccines. In Methods in Molecular Biology (pp. 203-222). (Methods in Molecular Biology; Vol. 1499). Humana Press Inc.. https://doi.org/10.1007/978-1-4939-6481-9_13