| Chapter title |
The European Regulatory Environment of RNA-Based Vaccines.
|
|---|---|
| Chapter number | 13 |
| Book title |
RNA Vaccines
|
| Published in |
Methods in molecular biology, January 2017
|
| DOI | 10.1007/978-1-4939-6481-9_13 |
| Pubmed ID | |
| Book ISBNs |
978-1-4939-6479-6, 978-1-4939-6481-9
|
| Authors |
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, Hinz, Thomas, Kallen, Kajo, Britten, Cedrik M., Flamion, Bruno, Granzer, Ulrich, Hoos, Axel, Huber, Christoph, Khleif, Samir, Kreiter, Sebastian, Rammensee, Hans-Georg, Sahin, Ugur, Singh-Jasuja, Harpreet, Türeci, Özlem, Kalinke, Ulrich, Hans Georg Rammensee |
| Editors |
Thomas Kramps, Knut Elbers |
| 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. |
X Demographics
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Germany | 13 | 12% |
| United Kingdom | 11 | 10% |
| Netherlands | 4 | 4% |
| Japan | 2 | 2% |
| United States | 2 | 2% |
| Australia | 1 | <1% |
| Canada | 1 | <1% |
| France | 1 | <1% |
| Puerto Rico | 1 | <1% |
| Other | 4 | 4% |
| Unknown | 71 | 64% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 101 | 91% |
| Science communicators (journalists, bloggers, editors) | 5 | 5% |
| Practitioners (doctors, other healthcare professionals) | 4 | 4% |
| Scientists | 1 | <1% |
Mendeley readers
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 63 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 10 | 16% |
| Student > Ph. D. Student | 9 | 14% |
| Researcher | 8 | 13% |
| Student > Bachelor | 6 | 10% |
| Other | 4 | 6% |
| Other | 6 | 10% |
| Unknown | 20 | 32% |
| Readers by discipline | Count | As % |
|---|---|---|
| Biochemistry, Genetics and Molecular Biology | 6 | 10% |
| Agricultural and Biological Sciences | 5 | 8% |
| Medicine and Dentistry | 5 | 8% |
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 8% |
| Immunology and Microbiology | 3 | 5% |
| Other | 14 | 22% |
| Unknown | 25 | 40% |