RNA Vaccines

Volume 1499 of the series Methods in Molecular Biology pp 203-222


The European Regulatory Environment of RNA-Based Vaccines

  • Thomas HinzAffiliated withSection for Therapeutic Vaccines, Division for Immunology, Paul-Ehrlich-Institut Email author  
  • , Kajo KallenAffiliated withKallen Consulting 
  • , Cedrik M. BrittenAffiliated withR&D Oncology, Glaxo Smith Kline
  • , Bruno FlamionAffiliated withURPhyM, NARILIS, University of Namur
  • , Ulrich GranzerAffiliated withGranzer, Regulatory Consulting & Services
  • , Axel HoosAffiliated withGlaxo Smith Kline
  • , Christoph HuberAffiliated withAssociation for Cancer Immunotherapy
  • , Samir KhleifAffiliated withGHSU Cancer Center
  • , Sebastian KreiterAffiliated withAssociation for Cancer Immunotherapy
    • , Hans-Georg RammenseeAffiliated withDepartment of Immunology, Institute for Cell Biology, University of TübingenGerman Cancer Consortium, DKFZ Partner Site
    • , Ugur SahinAffiliated withTRON – Translational Oncology at the University Medical Center, Johannes Gutenberg UniversityBiopharmaceutical New Technologies (BioNTech) CorporationResearch Center for Immunotherapy (FZI)
    • , Harpreet Singh-JasujaAffiliated withImmatics Biotechnologies GmbH
    • , Özlem TüreciAffiliated withCI3, Cluster for individualized Immune Intervention
    • , Ulrich KalinkeAffiliated withInstitute for Experimental Infection Research, Twincore, Centre for Experimental and Clinical Infection Research a joint venture between the Hannover Medical School and the Helmholtz Centre for Infection Research Email author 

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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