RNA Vaccines pp 203-222 | Cite as

The European Regulatory Environment of RNA-Based Vaccines

  • Thomas HinzEmail author
  • 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 KalinkeEmail author
Part of the Methods in Molecular Biology book series (MIMB, volume 1499)


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.


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



This chapter was issued as a joint effort by the Regulatory Research Group (RRG). The RRG was founded within the Association for Cancer Immunotherapy (CIMT) in 2008 as an independent group of experts focusing on regulatory aspects of drug development. CIMT was founded in 2002 by physicians and researchers from different fields of clinical and theoretical medicine as an independent nonprofit organization (


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Copyright information

© Springer Science+Business Media New York 2017

Authors and Affiliations

  • Thomas Hinz
    • 1
    Email author
  • Kajo Kallen
    • 2
  • Cedrik M. Britten
    • 3
  • Bruno Flamion
    • 4
  • Ulrich Granzer
    • 5
  • Axel Hoos
    • 6
  • Christoph Huber
    • 7
  • Samir Khleif
    • 8
  • Sebastian Kreiter
    • 7
  • Hans-Georg Rammensee
    • 9
    • 10
  • Ugur Sahin
    • 11
    • 12
    • 16
  • Harpreet Singh-Jasuja
    • 13
  • Özlem Türeci
    • 14
  • Ulrich Kalinke
    • 15
    Email author
  1. 1.Section for Therapeutic Vaccines, Division for ImmunologyPaul-Ehrlich-InstitutLangenGermany
  2. 2.Kallen ConsultingKöln/FrechenGermany
  3. 3.R&D OncologyGlaxo Smith KlineStevenageUK
  4. 4.URPhyM, NARILISUniversity of NamurNamurBelgium
  5. 5.Granzer, Regulatory Consulting & ServicesMunichGermany
  6. 6.Glaxo Smith KlineCollegevilleUSA
  7. 7.Association for Cancer ImmunotherapyMainzGermany
  8. 8.GHSU Cancer CenterAugustaUSA
  9. 9.Department of Immunology, Institute for Cell BiologyUniversity of TübingenTübingenGermany
  10. 10.German Cancer ConsortiumDKFZ Partner SiteTübingenGermany
  11. 11.TRON – Translational Oncology at the University Medical CenterJohannes Gutenberg UniversityMainzGermany
  12. 12.Biopharmaceutical New Technologies (BioNTech) CorporationMainzGermany
  13. 13.Immatics Biotechnologies GmbHTübingenGermany
  14. 14.CI3, Cluster for individualized Immune InterventionMainzGermany
  15. 15.Institute for Experimental Infection Research, TwincoreCentre for Experimental and Clinical Infection Research a joint venture between the Hannover Medical School and the Helmholtz Centre for Infection ResearchHannoverGermany
  16. 16.Research Center for Immunotherapy (FZI)MainzGermany

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