Replacement of in vivo leptospirosis vaccine potency testing in the United States.

Autor: Rogers B; PETA Science Consortium International e.V, Friolzheimer Str. 3, 70499, Stuttgart, Germany. Electronic address: bridgetr@thepsci.eu., Brown J; PETA Science Consortium International e.V, Friolzheimer Str. 3, 70499, Stuttgart, Germany., Allen DG; Inotiv Inc, PO Box 13501, Research Triangle Park, NC, 27709, USA., Casey W; Predictive Toxicology Branch, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, PO Box 12233, MD:K2-16, Research Triangle Park, NC, 27709, USA., Clippinger AJ; PETA Science Consortium International e.V, Friolzheimer Str. 3, 70499, Stuttgart, Germany.
Jazyk: angličtina
Zdroj: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2022 Jul; Vol. 78, pp. 36-44. Date of Electronic Publication: 2022 Jun 24.
DOI: 10.1016/j.biologicals.2022.05.001
Abstrakt: The U.S. Department of Agriculture (USDA) regulates the potency testing of leptospirosis vaccines, which are administered to animals to protect against infection by Leptospira bacteria. Despite the long-term availability of in vitro test methods for assessing batch potency, the use of hamsters in lethal in vivo batch potency testing persists to varying degrees across leptospirosis vaccine manufacturers. For all manufacturers of these products, data collected from public USDA records show an estimated 40% decline in the annual use of hamsters from 2014 to 2020, with an estimated 55% decrease in the number of hamsters expected to have been used in leptospirosis vaccine potency tests (i.e., those in USDA Category E). An estimated 49,000 hamsters were used in 2020, with about 15,000 hamsters in Category E specifically. Based on this assessment, additional efforts are needed to fully implement in vitro batch potency testing as a replacement for the in vivo batch potency test. We propose steps that can be taken collaboratively by the USDA Center for Veterinary Biologics (CVB), manufacturers of leptospirosis vaccines, government agencies, and non-governmental organizations to accelerate broader use of the in vitro approach.
(Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: