Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities.

Autor: Akkermans A; National Institute for Public Health and the Environment (RIVM), the Netherlands., Chapsal JM; European Partnership for Alternatives to Animal Testing (EPAA), France., Coccia EM; Istituto Superiore di Sanità, Italy., Depraetere H; CEO, European Vaccine Initiative (EVI), Germany., Dierick JF; GSK, Belgium., Duangkhae P; Government Pharmaceutical Organization, Thailand., Goel S; Serum Institute of India Pvt. Ltd., India., Halder M; European Commission, Joint Research Centre (JRC), Ispra, Italy., Hendriksen C; Intravacc, the Netherlands., Levis R; Food and Drug Administration (FDA / CBER), USA., Pinyosukhee K; Ministry of Public Health, Thailand., Pullirsch D; The Austrian Agency for Health and Food Safety (AGES), Austria., Sanyal G; Vaccine Analytics, LLC, USA., Shi L; Shanghai Zerun Biotechnology Company, China., Sitrin R; PATH, USA., Smith D; Health Canada, Canada., Stickings P; The National Institute for Biological Standards and Control (NIBSC), United Kingdom., Terao E; European Directorate for the Quality of Medicines & Healthcare (EDQM), France., Uhlrich S; Sanofi Pasteur, France., Viviani L; Independent Consultant, Humane Society International, Switzerland. Electronic address: vivianilaur@gmail.com., Webster J; World Organization for Animal Health (OIE), New Zealand.
Jazyk: angličtina
Zdroj: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2020 Nov; Vol. 68, pp. 92-107. Date of Electronic Publication: 2020 Oct 08.
DOI: 10.1016/j.biologicals.2020.07.010
Abstrakt: Transition to in vitro alternative methods from in vivo in vaccine release testing and characterization, the implementation of the consistency approach, and a drive towards international harmonization of regulatory requirements are most pressing needs in the field of vaccines. It is critical for global vaccine community to work together to secure effective progress towards animal welfare and to ensure that vaccines of ever higher quality can reach the populations in need in the shortest possible timeframe. Advancements in the field, case studies, and experiences from Low and Middle Income Countries (LMIC) were the topics discussed by an international gathering of experts during a recent conference titled "Animal Testing for Vaccines - Implementing Replacement, Reduction and Refinement: Challenges and Priorities". This conference was organized by the International Alliance for Biological Standardization (IABS), and held in Bangkok, Thailand on December 3 and 4 2019. Participants comprised stakeholders from many parts of the world, including vaccine developers, manufacturers and regulators from Asia, Europe, North America, Australia and New Zealand. In interactive workshops and vibrant panel discussions, the attendees worked together to identify the remaining barriers to validation, acceptance and implementation of alternative methods, and how harmonization could be promoted, especially for LMICs.
(Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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