- Email: [email protected]
Letter to the editor of travel medicine and infectious disease
Travel Medicine and Infectious Disease (2011) 9, 83 available at www.sciencedirect.com
journal homepage: www.elsevierhealth.com/journals/tmid
CORRESPONDENCE
Letter to the editor of travel medicine and infectious disease We note the paper by Petri and colleagues describing the epidemiology of tick-borne encephalitis (TBE), vaccination policies and the two TBE vaccines licensed in Europe FSMEIMMUN (Baxter) and Encepur (Novartis).1 In general, this review contains substantive information on most topics discussed, however unfortunately some inaccurate information about FSME-IMMUN is provided to the reader. Discussing the use of human serum albumin (HSA) in the formulation of FSME IMMUN, Petri et al. state that after the removal of HSA, the vaccine met recommendations issued by the European Medicines Agency (EMA), suggesting that adding HSA to a medicinal product is not in line with EMA recommendations. This is clearly a misinterpretation of CHMP’s Note for Guidance on Plasma-derived Medicinal Products2 (CHMP/BWP/269/95 rev.3, effective since 2001). Although this Note for Guidance encourages the development of substitutes to plasma derived components, it does not recommend removal of HSA from human medicinal products. Albumin derived from human plasma has never transmitted infectious viruses or TSE, a fact that is well recognized by regulatory agencies.3 Albumin is used as a stabilizer in a variety of medicinal products and the wording used by Petri et al. has the potential to cast unjustified doubt on the safety of these products. Furthermore, in Table 2, the authors incorrectly state that in Germany, the booster interval for FSME-IMMUN Junior is three years. In fact, the booster interval for FSMEJunior is three to five years throughout Europe. According to the Summary of Product Characteristics, the interval
1477-8939/$ - see front matter ª 2011 Published by Elsevier Ltd. doi:10.1016/j.tmaid.2011.01.003
should follow official recommendations based on local epidemiology and experience. We consider it appropriate to correct the erroneous information.
Conflict of interest HJE, RP, PNB are employees of Baxter BioScience.
References 1. Petri E, Gniel D, Zent O. Travel Med Infect Dis 2010 Jul;8(4): 233e45. 2. EMA. CPMP. Note for guidance on plasma-derived medicinal products. Doc. Ref. CPMP/BWP/269/95 rev. 3. 3. Center for Biologics Evaluation and Research (CBER, FDA). Issue summary transmissible spongiform encephalopathies advisory committee meeting; October 28, 2010.
Hartmut J. Ehrlich Robert Petermann* P. Noel Barrett Baxter BioScience, Wagramer strasse 17e19, 1220 Vienna, Austria * Corresponding author. Tel.: þ43 1 20100 2895; fax: þ43 1 20100 534. E-mail address: [email protected] (R. Petermann)
12 January 2011 Available online 21 February 2011
journal homepage: www.elsevierhealth.com/journals/tmid
CORRESPONDENCE
Letter to the editor of travel medicine and infectious disease We note the paper by Petri and colleagues describing the epidemiology of tick-borne encephalitis (TBE), vaccination policies and the two TBE vaccines licensed in Europe FSMEIMMUN (Baxter) and Encepur (Novartis).1 In general, this review contains substantive information on most topics discussed, however unfortunately some inaccurate information about FSME-IMMUN is provided to the reader. Discussing the use of human serum albumin (HSA) in the formulation of FSME IMMUN, Petri et al. state that after the removal of HSA, the vaccine met recommendations issued by the European Medicines Agency (EMA), suggesting that adding HSA to a medicinal product is not in line with EMA recommendations. This is clearly a misinterpretation of CHMP’s Note for Guidance on Plasma-derived Medicinal Products2 (CHMP/BWP/269/95 rev.3, effective since 2001). Although this Note for Guidance encourages the development of substitutes to plasma derived components, it does not recommend removal of HSA from human medicinal products. Albumin derived from human plasma has never transmitted infectious viruses or TSE, a fact that is well recognized by regulatory agencies.3 Albumin is used as a stabilizer in a variety of medicinal products and the wording used by Petri et al. has the potential to cast unjustified doubt on the safety of these products. Furthermore, in Table 2, the authors incorrectly state that in Germany, the booster interval for FSME-IMMUN Junior is three years. In fact, the booster interval for FSMEJunior is three to five years throughout Europe. According to the Summary of Product Characteristics, the interval
1477-8939/$ - see front matter ª 2011 Published by Elsevier Ltd. doi:10.1016/j.tmaid.2011.01.003
should follow official recommendations based on local epidemiology and experience. We consider it appropriate to correct the erroneous information.
Conflict of interest HJE, RP, PNB are employees of Baxter BioScience.
References 1. Petri E, Gniel D, Zent O. Travel Med Infect Dis 2010 Jul;8(4): 233e45. 2. EMA. CPMP. Note for guidance on plasma-derived medicinal products. Doc. Ref. CPMP/BWP/269/95 rev. 3. 3. Center for Biologics Evaluation and Research (CBER, FDA). Issue summary transmissible spongiform encephalopathies advisory committee meeting; October 28, 2010.
Hartmut J. Ehrlich Robert Petermann* P. Noel Barrett Baxter BioScience, Wagramer strasse 17e19, 1220 Vienna, Austria * Corresponding author. Tel.: þ43 1 20100 2895; fax: þ43 1 20100 534. E-mail address: [email protected] (R. Petermann)
12 January 2011 Available online 21 February 2011