Current Trends Withdrawal of Approval for Subcutaneous
Administration of Norden Rabies Vaccines for Dogs and Cats
Effective August 17, 1987, the U.S. Department of Agriculture
(USDA) is withdrawing approval for subcutaneous administration of
Endurall-K*and Rabguard-TC*, manufactured by Norden Laboratories,
Inc., Lincoln, Nebraska Endurall-K (a vaccine that imparts a 1-year
duration of immunity) and Rabguard-TC (a 3-year vaccine) should now
be
administered only intramuscularly to dogs and cats.
In July 1985, the USDA gave provisional approval for
subcutaneous
administration of these vaccines to dogs and cats, pending
completion
of a duration-of-immunity study and rabies challenge tests. In the
study, rabies-neutralizing antibody responses following
subcutaneous
vaccination were comparable to those observed following
intramuscular
vaccination throughout the 3 years after vaccination. However, when
dogs and cats were injected with live rabies virus in separate
challenge studies, they were not adequately protected 3 years after
subcutaneous vaccination. Therefore, all dogs and cats that
received
these vaccines subcutaneously should be revaccinated
intramuscularly
with a Norden vaccine or with another approved vaccine (1). Since
July
1985, several million doses of these vaccines have been sold
annually
in the United States and Canada (Norden Laboratories, Inc.,
unpublished data). The number of animals vaccinated subcutaneously
is
not known.
Veterinarians who have administered the Norden vaccines
subcutaneously should inform pet owners of the need for
revaccination.
Health agencies and other organizations that have sponsored rabies
vaccination clinics should inform their communities. Questions
regarding procedures for revaccination should be addressed to
Norden
Laboratories, Inc., collect, at (402) 475-6843 between 8:00 a.m.
and
4:00 p.m. CDST. This withdrawal of approval for subcutaneous
administration of Norden vaccines does not apply to other rabies
vaccines licensed for subcutaneous use.
Reported by: Veterinary Svcs, USDA. Viral and Rickettsial Zoonoses
Br,
Div of Viral Diseases, Center for Infectious Diseases, CDC.
Editorial Note
Editorial Note: The rabies challenge study was conducted with
laboratory dogs and cats 3 years after they had received only a
single
dose of vaccine subcutaneously. It is likely that most pets have
received more than one rabies vaccination because the recommended
schedule for primary rabies immunization in dogs and cats is an
initial dose at 3 months of age, followed by an additional dose 1
year
later (1). Therefore, most animals receiving a Norden vaccine
subcutaneously for primary immunization should have already
received a
second vaccination. In addition, because the vaccines were not
approved for subcutaneous use until July 1985, most dogs and cats
receiving them subcutaneously as booster immunizations should have
received at least one previous immunization with an approved
vaccine
by an approved route.
The level of protection conferred by administering the Norden
vaccines subcutaneously in a primary immunization series (2 doses)
or
a booster immunization is not known. Therefore, animals that have
received the Norden vaccines subcutaneously but have not been
subsequently revaccinated intramuscularly with a Norden vaccine or
another approved vaccine should be regarded as unvaccinated for the
purposes of rabies postexposure management.
References
CDC. Compendium of animal rabies control, 1987--prepared by:
the
National Association of State Public Health Veterinians, Inc.,
(sic). MMWR 1987;35:807-10, 815-8.
*Use of trade names is for identification only and does not imply
endorsement by the U.S. Department of Health and Human Services or
the
Public Health Service.
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