Page 458 - TBE_Book_V2_2019

Chapter 14: Prevention

Russian vaccines and almost no data are of the Austrian Green Cross and included 500
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available on the Chinese vaccine. Frequently selected pediatricians and general practition-
reported reactions after TBE vaccination ers who generated data on more than 25,000
basically do not differ from those occurring vaccinations (85% with FSME-IMMUN). A total
after vaccination with other aluminum- of 107 adverse events (AEs) were reported,
adjuvanted vaccines, e.g., local pain, redness, with 69 (64.5%) of these occurring in children
and swelling at the injection site, as well as below the age of 2 years; also, 75.8% of the
headache, fatigue, malaise, muscle pain, joint AEs were reported in association with the first
pain, and fever. vaccination. Fever was reported in 63 cases;
45 of these cases were mild, 15 moderate, and
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Safety has been investigated in the context of 3 severe (fever >39.5° C).
many clinical studies with FSME-IMMUN,
involving more than 13,800 children and Data derived from spontaneous reporting to
adults. 9-11,13,14,50 All adverse reactions ob- the pharmacovigilance departments of
served during clinical studies and relevant manufacturers of both vaccines (FSME-
reports to the pharmacovigilance departments IMMUN, for the period between 2001 and
of the manufacturers are summarized in the 2009, and Encepur, for the period between
Summary of Product Characteristics, Table 3. 2002 and 2009) indicate comparable rates of
The most frequently reported reactions to the serious AEs (1.57 per 100,000 doses
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vaccination are local pain (≥1/10), headache, administered). According to safety grading,
fatigue, malaise, myalgia, and arthralgia as published in a WHO position paper in 2011,
(1/100 and <1/10), whereas the frequency of currently available TBE vaccines are not
fever was uncommon (≥1/1.000 and <1/100). causally associated with serious adverse
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Adverse reactions to vaccination seen in vaccine reactions. Finally, although the
children are similar to those observed in safety sections of the SMPCs for FSME IMMUN
adults. However, children more frequently and Encepur show some differences, it can be
experience fever, especially young children concluded that both vaccines have a similar
after the first vaccination. In addition, young safety and reactogenicity profile.
children commonly react to vaccination with
irritability, appetite loss, and disturbed sleep. According to the Russian National Regulatory
Authority, both Russian vaccines – TBE-
Similarly, at least 4 clinical trials have Moscow and EnceVir – are safe and well
established the safety profile of Encepur in tolerated, 33,41 and their manufacturing
children and adults 12,18,20,22 (Table 3). Similar to process fulfills WHO standards. However, no
FSME-IMMUN, the most frequently reported official documentation of quality control exists
reactions to vaccination with Encepur are local and no published data from large, controlled
pain, malaise, myalgia, and headache (>10% of safety trials are available. Small-scale
vaccinees), whereas local redness, swelling, observational studies with TBE-Moscow and
flu-like symptoms, nausea, arthralgia, and EnceVir have suggested a moderate
fever (primarily after the first vaccination) reactogenicity profile with no significant
were observed in 1–10% of the vaccinees. differences between the 2 vaccines. Post-
marketing surveillance data did not identify
As of 2002, 2 TBE pediatric vaccines, FSME- any serious AEs. 26,32,72
IMMUN Junior (Baxter) and Encepur Children
(Novartis/GSK), were marketed and at that A study in children between 7 and 17 years of
time a post-marketing sentinel study was age comparing TBE-Moscow vaccine and
carried out in Austria. The study was FSME-Immun (old formulation; adult dose
conducted by the Institute for Vaccine Safety used also for children) found that fever was

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