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African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines

The recent centennial anniversary of R.E. Montgomery’s seminal published description of “a form of swine fever” disease transmitted from wild African pigs to European domestic pigs is a call to action to accelerate African Swine Fever (ASF) vaccine research and development. ASF modified live virus (...

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Autor principal: Brake, David A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9788307/
https://www.ncbi.nlm.nih.gov/pubmed/36560623
http://dx.doi.org/10.3390/v14122619
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author Brake, David A.
author_facet Brake, David A.
author_sort Brake, David A.
collection PubMed
description The recent centennial anniversary of R.E. Montgomery’s seminal published description of “a form of swine fever” disease transmitted from wild African pigs to European domestic pigs is a call to action to accelerate African Swine Fever (ASF) vaccine research and development. ASF modified live virus (MLV) first-generation gene deleted vaccine candidates currently offer the most promise to meet international and national guidelines and regulatory requirements for veterinary product licensure and market authorization. A major, rate-limiting impediment to the acceleration of current as well as future vaccine candidates into regulatory development is the absence of internationally harmonized standards for assessing vaccine purity, potency, safety, and efficacy. This review summarizes the asymmetrical landscape of peer-reviewed published literature on ASF MLV vaccine approaches and lead candidates, primarily studied to date in the research laboratory in proof-of-concept or early feasibility clinical safety and efficacy studies. Initial recommendations are offered toward eventual consensus of international harmonized guidelines and standards for ASF MLV vaccine purity, potency, safety, and efficacy. To help ensure the successful regulatory development and approval of ASF MLV first generation vaccines by national regulatory associated government agencies, the World Organisation for Animal Health (WOAH) establishment and publication of harmonized international guidelines is paramount.
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spelling pubmed-97883072022-12-24 African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines Brake, David A. Viruses Review The recent centennial anniversary of R.E. Montgomery’s seminal published description of “a form of swine fever” disease transmitted from wild African pigs to European domestic pigs is a call to action to accelerate African Swine Fever (ASF) vaccine research and development. ASF modified live virus (MLV) first-generation gene deleted vaccine candidates currently offer the most promise to meet international and national guidelines and regulatory requirements for veterinary product licensure and market authorization. A major, rate-limiting impediment to the acceleration of current as well as future vaccine candidates into regulatory development is the absence of internationally harmonized standards for assessing vaccine purity, potency, safety, and efficacy. This review summarizes the asymmetrical landscape of peer-reviewed published literature on ASF MLV vaccine approaches and lead candidates, primarily studied to date in the research laboratory in proof-of-concept or early feasibility clinical safety and efficacy studies. Initial recommendations are offered toward eventual consensus of international harmonized guidelines and standards for ASF MLV vaccine purity, potency, safety, and efficacy. To help ensure the successful regulatory development and approval of ASF MLV first generation vaccines by national regulatory associated government agencies, the World Organisation for Animal Health (WOAH) establishment and publication of harmonized international guidelines is paramount. MDPI 2022-11-24 /pmc/articles/PMC9788307/ /pubmed/36560623 http://dx.doi.org/10.3390/v14122619 Text en © 2022 by the author. 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
Brake, David A.
African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines
title African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines
title_full African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines
title_fullStr African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines
title_full_unstemmed African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines
title_short African Swine Fever Modified Live Vaccine Candidates: Transitioning from Discovery to Product Development through Harmonized Standards and Guidelines
title_sort african swine fever modified live vaccine candidates: transitioning from discovery to product development through harmonized standards and guidelines
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9788307/
https://www.ncbi.nlm.nih.gov/pubmed/36560623
http://dx.doi.org/10.3390/v14122619
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