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Por favor anote:
Comenzando el 25 de febrero de 2002, la vacuna LYMErix™ para la
enfermedad del Lyme, no
estára disponible comercialmente. Las suiguientes guías y
recomendaciones se aplican a la vacuna que actualmente está en uso.
Summary
of Guidelines for Use of Human
Lyme Disease Vaccine in California
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Routine
vaccination is not recommended anywhere in California.
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Individuals
who have frequent or prolonged contact with natural vegetation
(including leaf litter) in tick habitat in areas known to have
moderate risk
(i.e., more than low or no risk) for Lyme disease should consider
vaccination and discuss the risks and benefits with their physician.
-
Use
of the vaccine should not deviate from FDA and package insert
guidelines for
vaccine administration and schedule.
-
Vaccination
is not a substitute for personal measures to prevent tick bites
and tick-transmitted diseases.
-
LYMErix TM (SmithKline
Beecham Pharmaceuticals) is a recombinant vaccine
based on a well-conserved antigen of Borrelia
burgdorferi known as
outer surface protein A (Osp A). In a vaccinated individual, anti-OspA antibody,
ingested during the tick’s bloodmeal, will bind with and inactivate the B. burgdorferi
spirochetes in the tick’s midgut, interrupt spirochetal
migration to the salivary gland and transmission to the human host.
-
Lyme disease (LD)
vaccine administration and schedule should not deviate
from FDA and package insert guidelines, which advise that the vaccine be administered in three
intramuscular injections: at zero, one, and
12 months. Antibodies diminish with time so periodic (e.g.,
annual) boosters
may be necessary. Exact booster schedules have not yet been determined. Safety
and efficacy studies have not been published regarding simultaneous
administration of the LD vaccine with other vaccines.
-
LYMErix TM vaccine
should only be administered to healthy persons between
15 and 70 years old. The vaccine is neither licensed nor recommended
for use in persons younger than 15 or older than 70 years old since these age
groups were not included in the vaccine field trials and comprehensive
information on the safety and efficacy of the vaccine in these age groups is
unavailable. The vaccine is currently not recommended for pregnant women,
immunocompromised individuals, or patients with chronic arthritis since
there are no published safety or efficacy studies of the vaccine in these groups.
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