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

Adopted Reference Number: EMA/CHMP/BWP/192228/2017

Document history

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

Adopted Reference Number: EMA/CHMP/BWP/192228/2017

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

Adopted Reference Number: EMA/CHMP/BWP/637549/2018

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

Draft: consultation closed Consultation dates: 01/02/2018 to 31/07/2018 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.

Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - First version

Adopted Reference Number: EMEA/CPMP/BWP/819/01 Legal effective date: 23/04/2001

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

Adopted Reference Number: EMEA/CPMP/BWP/476/01 Legal effective date: 28/02/2001