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Chapter 14: Prevention

the mutual recognition procedure (MRP) of underwent several changes over subsequent
the European Medicines Agency (EMA), and decades until 2000. The actual licensed
Encepur, which has several national licenses. vaccine is a formaldehyde-inactivated, whole-
They are distributed mainly in Europe and virus vaccine (2.4 mcg antigen per dose),
Israel, while the other TBE vaccines are adjuvanted with aluminum hydroxide and
predominantly produced for local markets. containing HSA as an essential stabilizer.
Details of the actual formulation are described
in Table 1. A pediatric formulation containing
Manufacturer and products half of the adult dose (FSME-IMMUN Junior)
was licensed in 2002. The current
TBE vaccines are produced commercially by 5 manufacturer of FSME-IMMUN is Pfizer.
manufacturers. Two are produced in Europe, 1
by Pfizer (Vienna, Austria), 1 by GSK Vaccines Encepur
(Marburg, Germany); 2 in Russia: IPVE
(Moscow, Russia) and Microgen (Tomsk, This vaccine is based on the European subtype
Russia); and 1 in China: Sen Tai Bao virus strain K23, isolated in southern Germany
(Changchun Institute of Biological Products and originally licensed first in Germany in
Co., Ltd.; CIBP). The 2 manufacturers in 1991 as Encepur by Chiron Behring, Marburg,
1
Europe use very similar manufacturing Germany. Similar to FSME-IMMUN, the seed
processes but different virus strains and virus for this vaccine is grown on primary chick
stabilizers. Both of them have licensed embryo cells. The virus is inactivated by
formulations for adults (Pfizer: FSME-IMMUN; formaldehyde, is adsorbed onto aluminum
GSK: Encepur) and for children older than 1 hydroxide, and contains 1.5 mcg of antigen. A
year (Pfizer: FSME- IMMUN Junior; GSK: pediatric formulation containing half the adult
Encepur-Children). FSME-IMMUN Junior is dose (Table 1) has been available since 1994. 2
licensed for children up to 15 years of age, The genomic sequence of the K23 vaccine
whereas Encepur-Children is licensed up to 12 virus in the Encepur formulation has
years of age. In some countries, FSME-IMMUN mutations compared to the originally
90
is marketed as TicoVac. Neither the Russian published sequence. However, the clinical
nor the Chinese TBE vaccines have pediatric impact of the modified primary amino acid
formulations. Only the TBE-Moscow vaccine is sequence is unknown.
approved for use in children age 3 years or
older. Human serum albumin (HSA) is used as Russian vaccines
a stabilizer by Pfizer, IPVE, CIBP, and
Microgen, whereas GSK uses an increased Three TBE vaccines have been developed and
amount of sucrose as a stabilizer. An overview are marketed in Russia (see Chapter 12b:
of the excipients of the European and Russian Russia). All of them are cultured on chick
vaccines is shown in Table 1. embryo cells and are formalin- inactivated.
EnceVir, manufactured by Microgen, Tomsk, is
4
FSME-IMMUN based on the TBEV-Fe subtype strain 205.
This vaccine is based on the Austrian TBE There is a vaccine for adults (EnceVir (0.5) and
strain Neudörfl (TBEV-Eu) and was licensed as of recently, also a pediatric formulation
first in 1976. The virus was primarily passaged (EnceVir Neo (0.25) for children 3-17 years).
in the brains of specific pathogen-free (SPF) Klesch-E-Vac is based on the TBEV-Fe
baby mice and then propagated in primary SPF prototype strain Sofjin, and manufactured by
chicken embryo cells. The vaccine formulation the Federal State Enterprise of Chumakov

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