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Vaccines for emerging pathogens: prospects for licensure
Globally, there are a number of emerging pathogens. For most, there are no licensed vaccines available for human use, although there is ongoing research and development. However, given the extensive and increasing list of emerging pathogens and the investment required to bring vaccines into clinical...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797873/ https://www.ncbi.nlm.nih.gov/pubmed/30972733 http://dx.doi.org/10.1111/cei.13284 |
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author | Williamson, E. D. Westlake, G. E. |
author_facet | Williamson, E. D. Westlake, G. E. |
author_sort | Williamson, E. D. |
collection | PubMed |
description | Globally, there are a number of emerging pathogens. For most, there are no licensed vaccines available for human use, although there is ongoing research and development. However, given the extensive and increasing list of emerging pathogens and the investment required to bring vaccines into clinical use, the task is huge. Overlaid on this task is the risk of anti‐microbial resistance (AMR) acquisition by micro‐organisms which can endow a relatively harmless organism with pathogenic potential. Furthermore, climate change also introduces a challenge by causing some of the insect vectors and environmental conditions prevalent in tropical regions to begin to spread out from these traditional areas, thus increasing the risk of migration of zoonotic disease. Vaccination provides a defence against these emerging pathogens. However, vaccines for pathogens which cause severe, but occasional, disease outbreaks in endemic pockets have suffered from a lack of commercial incentive for development to a clinical standard, encompassing Phase III clinical trials for efficacy. An alternative is to develop such vaccines to request US Emergency Use Authorization (EUA), or equivalent status in the United States, Canada and the European Union, making use of a considerable number of regulatory mechanisms that are available prior to licensing. This review covers the status of vaccine development for some of the emerging pathogens, the hurdles that need to be overcome to achieve EUA or an equivalent regional or national status and how these considerations may impact vaccine development for the future, such that a more comprehensive stockpile of promising vaccines can be achieved. |
format | Online Article Text |
id | pubmed-6797873 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-67978732019-10-21 Vaccines for emerging pathogens: prospects for licensure Williamson, E. D. Westlake, G. E. Clin Exp Immunol Review Series: Vaccines for Emerging Pathogens: from Research to the Clinic. Part 2. Series Editor: E. Diane Williamson Globally, there are a number of emerging pathogens. For most, there are no licensed vaccines available for human use, although there is ongoing research and development. However, given the extensive and increasing list of emerging pathogens and the investment required to bring vaccines into clinical use, the task is huge. Overlaid on this task is the risk of anti‐microbial resistance (AMR) acquisition by micro‐organisms which can endow a relatively harmless organism with pathogenic potential. Furthermore, climate change also introduces a challenge by causing some of the insect vectors and environmental conditions prevalent in tropical regions to begin to spread out from these traditional areas, thus increasing the risk of migration of zoonotic disease. Vaccination provides a defence against these emerging pathogens. However, vaccines for pathogens which cause severe, but occasional, disease outbreaks in endemic pockets have suffered from a lack of commercial incentive for development to a clinical standard, encompassing Phase III clinical trials for efficacy. An alternative is to develop such vaccines to request US Emergency Use Authorization (EUA), or equivalent status in the United States, Canada and the European Union, making use of a considerable number of regulatory mechanisms that are available prior to licensing. This review covers the status of vaccine development for some of the emerging pathogens, the hurdles that need to be overcome to achieve EUA or an equivalent regional or national status and how these considerations may impact vaccine development for the future, such that a more comprehensive stockpile of promising vaccines can be achieved. John Wiley and Sons Inc. 2019-04-11 2019-11 /pmc/articles/PMC6797873/ /pubmed/30972733 http://dx.doi.org/10.1111/cei.13284 Text en © 2019 Crown copyright. Clinical and Experimental Immunology © 2019 British Society for Immunology. This article is published with the permission of the Controller of HMSO and the Queen's Printer for Scotland. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Review Series: Vaccines for Emerging Pathogens: from Research to the Clinic. Part 2. Series Editor: E. Diane Williamson Williamson, E. D. Westlake, G. E. Vaccines for emerging pathogens: prospects for licensure |
title | Vaccines for emerging pathogens: prospects for licensure |
title_full | Vaccines for emerging pathogens: prospects for licensure |
title_fullStr | Vaccines for emerging pathogens: prospects for licensure |
title_full_unstemmed | Vaccines for emerging pathogens: prospects for licensure |
title_short | Vaccines for emerging pathogens: prospects for licensure |
title_sort | vaccines for emerging pathogens: prospects for licensure |
topic | Review Series: Vaccines for Emerging Pathogens: from Research to the Clinic. Part 2. Series Editor: E. Diane Williamson |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797873/ https://www.ncbi.nlm.nih.gov/pubmed/30972733 http://dx.doi.org/10.1111/cei.13284 |
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