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A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development
A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9412622/ https://www.ncbi.nlm.nih.gov/pubmed/36016089 http://dx.doi.org/10.3390/vaccines10081201 |
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author | Taylor, Kimberly L. Lanning, Lynda Wolfraim, Lawrence Shrivastava Gales, Sonia Sico, Colleen Dowling, William E. Ward, Lucy A. Florence, William C. Nuzum, Edwin Bryant, Paula R. |
author_facet | Taylor, Kimberly L. Lanning, Lynda Wolfraim, Lawrence Shrivastava Gales, Sonia Sico, Colleen Dowling, William E. Ward, Lucy A. Florence, William C. Nuzum, Edwin Bryant, Paula R. |
author_sort | Taylor, Kimberly L. |
collection | PubMed |
description | A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and Drug Administration’s (FDA) Animal Rule (AR), non-human primate (NHP) models and associated assays have been developed and standardized across BSL4 testing sites to evaluate candidate products. Vaccine candidates are evaluated using these NHP models, and through this public–private partnership, a meta-analysis of NHP control data has been conducted and submitted to the FDA as a master file. This is an example of how existing NHP control data can be leveraged in lieu of conducting separate natural history studies at multiple testing facilities to demonstrate the consistency of a standardized animal model for vaccine development. As a result, animal use can be minimized and the duplication of effort avoided, thus reducing the amount of time needed to conduct additional studies, as well as the cost of vaccine candidate development. This successful strategy may be applied to other pathogens of high consequence for vaccine development, and shows how strategic preparedness for biodefense can be leveraged in response to outbreaks and public health emergencies. |
format | Online Article Text |
id | pubmed-9412622 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-94126222022-08-27 A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development Taylor, Kimberly L. Lanning, Lynda Wolfraim, Lawrence Shrivastava Gales, Sonia Sico, Colleen Dowling, William E. Ward, Lucy A. Florence, William C. Nuzum, Edwin Bryant, Paula R. Vaccines (Basel) Review A United States Government (USG) interagency group, the Filovirus Animal Non-Clinical Group (FANG), has been established to support the development of biodefense medical countermeasures (MCMs). As both vaccines and therapeutics are licensed using “non-traditional pathways”, such as the U.S. Food and Drug Administration’s (FDA) Animal Rule (AR), non-human primate (NHP) models and associated assays have been developed and standardized across BSL4 testing sites to evaluate candidate products. Vaccine candidates are evaluated using these NHP models, and through this public–private partnership, a meta-analysis of NHP control data has been conducted and submitted to the FDA as a master file. This is an example of how existing NHP control data can be leveraged in lieu of conducting separate natural history studies at multiple testing facilities to demonstrate the consistency of a standardized animal model for vaccine development. As a result, animal use can be minimized and the duplication of effort avoided, thus reducing the amount of time needed to conduct additional studies, as well as the cost of vaccine candidate development. This successful strategy may be applied to other pathogens of high consequence for vaccine development, and shows how strategic preparedness for biodefense can be leveraged in response to outbreaks and public health emergencies. MDPI 2022-07-28 /pmc/articles/PMC9412622/ /pubmed/36016089 http://dx.doi.org/10.3390/vaccines10081201 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Review Taylor, Kimberly L. Lanning, Lynda Wolfraim, Lawrence Shrivastava Gales, Sonia Sico, Colleen Dowling, William E. Ward, Lucy A. Florence, William C. Nuzum, Edwin Bryant, Paula R. A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development |
title | A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development |
title_full | A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development |
title_fullStr | A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development |
title_full_unstemmed | A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development |
title_short | A U.S. Government-Coordinated Effort to Leverage Non-Human Primate Data to Facilitate Ebolavirus Vaccine Development |
title_sort | u.s. government-coordinated effort to leverage non-human primate data to facilitate ebolavirus vaccine development |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9412622/ https://www.ncbi.nlm.nih.gov/pubmed/36016089 http://dx.doi.org/10.3390/vaccines10081201 |
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