References
- European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on adjuvants in vaccines for human use (EMEA/CHMP/VEG/134716/2004). 2005. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003809.pdf
- World Health Organisation, WHO Expert Committee on Biological StandardisationGuidelines on non-clinical evaluation of vaccines adjuvants and adjuvanted vaccines. 2013. Available online at: http://www.who.int/biologicals/areas/vaccines/ADJUVANTS_Post_ECBS_edited_clean_Guidelines_NCE_Adjuvant_Final_17122013_WEB.pdf?ua=1
- European Medicines Agency, Committee for Medicinal Products for Human Use. Explanatory note on immunomodulators for the guideline on adjuvants in vaccines for human use (EMEA/CHMP/VWP/244894/2006). 2006. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003810.pdf
- Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code related to medicinal products for human use. Offic J L 159:46–94. 1999
- European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on pharmaceutical and biological aspects of combined vaccines (CPMP/BWP/477/97). 1999. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003939.pdf
- European Medicines Agency, Committee for Medicinal Products for Human Use. Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99). 2001. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003987.pdf, accessed 1 Mar 2001
- Echeverria P, Dran G, Pereda G, et al. Analysis of the adjuvant effect of recombinant Leishmania infantum Hsp83 protein as a tool for vaccination. Immunol Lett 2001;76:107–110
- García-García JC, Montero C, Rodríguez M, et al. Adjuvant and immunostimulating properties of the recombinant Bm86 protein expressed in Pichia pastoris. Vaccine 1998;16:1053–1055
- European Medicines Agency, Committee for Medicinal Products for Human Use, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Note for guidance on quality of biotechnological products: Derivation and characterisation of cell substrates used for production of biotechnological/biological products (CPMP/ICH/294/95). 1998. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003280.pdf
- European Medicines Agency, Committee for Medicinal Products for Human Use, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Note for guidance on quality of biotechnological products: viral safety evaluation of biotechnology (CPMP/ICH/295/95). 1997. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002801.pdf
- European Medicines Agency, Committee for Medicinal Products for Human Use, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Note for guidance on quality of biotechnological products: analysis of the expression construct in cell lines used for production of r-DNA derived protein products (CPMP/ICH/139/95). 1995. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002802.pdf
- European Medicines Agency. Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3). 2011. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003700.pdf
- European Medicines Agency. Note for guidance on pre-clinical pharmacological testing of vaccines (CPMP/SWP465/95). 1997. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004004
- European Medicines Agency, Committee for Medicinal Products for Human Use, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use (EMA/CHMP/ICH/126642/2008). 2012. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/12/WC500119604.pdf
- European Medicines Agency, Committee for Medicinal Products for Human Use, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals (EMA/CHMP/ICH/731268/1998). 1998. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000432.jsp
- European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on requirements for first-in-men trials for potential high risk medicinal products (EMEA/CHMP/SWP/28367/2007 Corr.) 2007. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002989.pdf
- European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on clinical evaluation of new vaccines (EMEA/CHMP/VWP/164653/2005). 2006. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003870.pdf
- Ahmed SS, Schur PH, MacDonald NE, Steinman L. Narcolepsy, 2009 A(H1N1) pandemic influenza, and pandemic influenza vaccinations: What is known and unknown about the neurological disorder, the role of autoimmunity, and vaccine adjuvants. J Autoimmun 2014;50:1–11
- Pandemrix Influenza Vaccine H5N1 Baxter: EPAR–Product Information. 2008. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001200/human_med_001215.jsp&mid=WC0b01ac058001d124, accessed 31 Oct 2013
- Han F, Faraco J, Dong XS, et al. Genome wide analysis of narcolepsy in China implicates novel immune loci and reveals changes in association prior to versus after the 2009 H1N1 influenza pandemic. PLoS Genet 2013;9:e1003880
- European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on influenza vaccines. 2014. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/07/WC500170300.pdf
- European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases (EMA/CHMP/VWP/457259/2014). 2013. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/12/WC500157839.pdf
- European Medicines Agency, Committee for Medicinal Products for Human Use. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU (EMA/PRAC/222346/2014). 2014. Available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/04/WC500165492.pdf
- Withdrawal assessment report for Heplisav. 2014. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002603/wapp/Initial_authorisation/human_wapp_000174.jsp&mid=WC0b01ac058001d128