Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Scientific guideline

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.

Keywords: BSE safety, TSE, vaccines, vaccine manufacture, bovine materials, CJD, prions, gelatin, bovine serum, milk derivatives, polysorbate, tallow

Current effective version

Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Revision 1

English (EN) (134.3 KB - PDF)

Document history

Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Revision 1

English (EN) (134.3 KB - PDF)

Overview of comments received on ‘Questions and Answers on bovine spongiform encephalopathies (BSE) and vaccines’ (EMA/CHMP/BWP/192228/2017) - Revision 1

English (EN) (119.23 KB - PDF)

Draft questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Revision 1

Consultation dates: 01/02/2018 to 31/07/2018 Draft: consultation closed Reference Number: EMA/CHMP/BWP/192228/2017 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.

English (EN) (149.07 KB - PDF)