Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement

This one-day symposium organized by Humane Society International (HSI) brought together 18 international experts from Argentina, Brazil, China, Europe, India, Russia, South Africa and the United States to discuss the elimination of the abnormal toxicity test (ATT) from the testing requirements for h...

Full description

Saved in:

Bibliographic Details
Published in:	Biologicals Vol. 63; pp. 101 - 105
Main Authors:	Viviani, Laura, Halder, Marlies, Gruber, Marion, Bruckner, Lukas, Cussler, Klaus, Sanyal, Gautam, Srinivas, Geetha, Goel, Sunil, Kaashoek, Marianne, Litthauer, Derek, Lopes da Silva, Arthur Leonardo, Sakanyan, Elena, Aprea, Patricia, Jin, Hongtao, Vandeputte, Joris, Seidle, Troy, Yakunin, Dimitriy
Format:	Journal Article
Language:	English
Published:	England Elsevier Ltd 01-01-2020
Subjects:	Abnormal toxicity test Batch release testing Batch safety test Target animal safety testing Vaccines Batch safety test Batch release testing Vaccines Abnormal toxicity test Target animal safety testing
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	This one-day symposium organized by Humane Society International (HSI) brought together 18 international experts from Argentina, Brazil, China, Europe, India, Russia, South Africa and the United States to discuss the elimination of the abnormal toxicity test (ATT) from the testing requirements for human vaccines as well as the target animal batch safety test (TABST) and the laboratory animal batch safety test (LABST) for veterinary vaccines. Participants reported on country-specific regulatory requirements and, where present, the perspectives on waiver and elimination of those tests. In addition, the attendees, with HSI in the role of facilitator, moved to define the barriers to the complete elimination or waiving of these tests. This report expounds the outcomes of the symposium, and introduces a proposed roadmap – populated with country specific activities – for the elimination of these tests. •Agreement on need to delete abnormal toxicity test.•Agreement on need to waive/delete target animal batch safety test.•Stakeholders accepting role of change champions to waive/delete those safety tests.•Agreement to keep enlarging the number of involved stakeholders.
Bibliography:	ObjectType-Conference-1 content type line 23 SourceType-Scholarly Journals-1
ISSN:	1045-1056 1095-8320 1095-8320
DOI:	10.1016/j.biologicals.2019.10.007