Questions and answers on Bovine Spongiform Encephalopathies (BSE) and vaccines - Revision 1

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Document details

Download document Questions and answers on Bovine Spongiform Encephalopathies (BSE) and vaccines - Revision 1
Reference number EMA/CHMP/BWP/192228/2017
Status draft: consultation open
First published 2018-02-01
Last updated 2018-02-01
Consultation start date 2018-02-01
Consultation end date 2018-07-31
Email address for submissions kaidi.koiv@ema.europa.eu

Summary

This is an update of the information in the Public Statement on the Evaluation of Bovine Spongiform Encephalopathies (BSE) - risk via the use of materials of bovine origin in or during the manufacture of vaccines and the Questions and Answers on Bovine Spongiform Encephalopathies (BSE) and Vaccines. The public statement and Q&A were intended to provide an assessment of the risk due to BSE of the use of bovine materials in vaccines when they were drafted in 2001. Since 2001, understanding of the risks associated with BSE has progressed significantly and a routine review of EMA guidelines identified this document as requiring updating. It includes information on the use of bovine derived materials in vaccine manufacture.