Pfizer Animal Health
Feline
Rhinotracheitis-Calici-Panleukopenia Vaccine
Modified Live Virus
For use in cats only
PRODUCT DESCRIPTION: Fellocell 3 is
for vaccination of healthy cats as an aid in preventing feline viral
rhinotracheitis (FVR) caused by feline herpesvirus-1, feline respiratory
disease caused by feline calicivirus (FCV), and feline panleukopenia
(FPL) caused by feline parvovirus (FPV). Fellocell 3 contains attenuated
strains of feline rhinotracheitis virus, calicivirus, and panleukopenia
virus (Johnson Snow Leopard strain), propagated on established cell
lines. Fellocell 3 is packaged in freeze-dried form with inert gas in
place of vacuum.
SAFETY AND EFFICACY: Safety of
Fellocell 3 was demonstrated in field trials involving 2,288 cats. No
serious postvaccination reactions attributable to the vaccine were
reported.
Efficacy of Fellocell 3 was determined by
challenge-of-immunity tests. Vaccinated cats experienced significantly
less severe clinical signs than nonvaccinated control cats after
challenge with virulent FVR virus, FCV, or FPV. Efficacy of the FPV
fraction in Fellocell 3 was further established in a 3-year repeat
antigenicity study. Three years after initial efficacy studies were
conducted, FPV challenge tests were repeated. After challenge, all
vaccinated cats remained clinically healthy while 80% of control cats
developed clinical signs of FPL.
Results of serological studies indicated that no
immunologic interference existed among the vaccine fractions. In
specific pathogen-free cats, vaccination with Fellocell 3 stimulated
serum neutralization titers to each of the 3 vaccinal viruses.
DURATION OF SEROLOGIC RESPONSE: In
cats vaccinated and boostered as kittens, and then vaccinated again
approximately 1 year later, revaccination with Felocell 3 has been
demonstrated (under field conditions) to result in serum antibody titers
that persist for 12-36 months against FPV (hemagglutination inhibition
[HAI] titer ≥ 1:40) with FCV (serum neutralization [SN] titer ≥ 1:32)
and FHV (SN ≥ 1:16).
Protection against infectious agents involves a complex
interplay between humoral immunity, cellular immunity, or a combination
of both. The purpose of vaccination is to induce effector cells in both
these arms of the immune system. During the process, long-term immunity
in the form of memory T and B lymphocytes is produced. Memory cells and
antibodies interact to provide protection to an animal challenged with
the same pathogen at a later date. Depending on the vaccine and the
disease, antibodies may be produced that provide complete protection
from disease and prevent or reduce shedding. In other cases, antibodies
may play a minor or ineffective role and protection from disease relies
on systemic, local cellular immunity and/or local antibody production.
The role of sustained serological titers in the prevention of disease
has not been confirmed.
In companion animals, immunological response to
infection or vaccination has generally been evaluated by measuring the
level of antibodies in serum and correlating these with protection or
susceptibility. For certain diseases, such as feline panleukopenia,
evaluation of antibody titers can be a valuable diagnostic indicator to
determine when revaccination may be needed.1,2
For other diseases, a serological response has not been identified that
correlates with protection. Practical knowledge of the disease, the
vaccine and the patient, along with serologic test results when
appropriate, is paramount in making the best recommendation for a
vaccination protocol for a specific animal.
The duration and character of the immune response to the
viral antigens of Felocell were determined in a multi-center serology
study involving 40 small animal veterinary clinics located in the United
States (38) and Canada (2). Two hundred seventy-two male and female
(intact and neutered) cats of various ages, breeds, weights, lifestyles
and times since last vaccination were enrolled in the study. Cats were
required to be healthy, FeLV and FIV negative, ≥ 2 years old with no
history of disease due to FPV, FCV or FHV, and must not have been
vaccinated for 12-48 months or longer. Additionally, cats must have
received at least one priming vaccination series approximately 2-7 weeks
apart as a kitten and a booster vaccination approximately 8-16 months
later. All previously administered vaccines were Felocell CVR or
Felocell CVR-C. A blood sample was collected from each cat and serum
submitted to Cornell Veterinary Diagnostic Laboratory for determination
of FPV (HAI), FCV (SN) and FHV (SN) antibody titers. The samples were
sent to a single diagnostic laboratory, thus ensuring a standardized
test and methodology. As shown in the table below, elevated geometric
mean titers were sustained for 12 to ≥ 36 months after the last booster.
Since the study was conducted under field conditions with client-owned
animals, it is possible that natural exposure to infectious agents could
have occurred without clinical signs of infection during the course of
the study. In such cases, the titers measured in the study could be the
result of exposure to the disease in addition to vaccinations.
Table 1. Geometric mean
titer/number of cats3
Antigen
|
Time Since Last Vaccination (Months)
|
12-18
|
19-24
|
25-30
|
31-36
|
37-42
|
43-48
|
>48
|
FPV
|
1036/108
|
732/49
|
1026/25
|
654/19
|
617/25
|
659/13
|
472/33
|
FCV
|
430/108
|
433/49
|
219/25
|
180/19
|
323/25
|
430/13
|
687/33
|
FHV
|
41/108
|
46/49
|
41/25
|
39/19
|
27/25
|
45/13
|
36/33
|
DIRECTIONS:
1. General Directions:
Vaccination of healthy cats is recommended. Aseptically rehydrate the
freeze-dried vaccine with the sterile diluent provided, shake well, and
administer 1 mL intramuscularly or subcutaneously.
2. Primary Vaccination: Healthy
cats 12 weeks of age or older should receive 2 doses administered 3-4
weeks apart. Cats vaccinated at less than 12 weeks of age should be
revaccinated at 12 weeks of age.
3. Revaccination: Annual
revaccination with a single dose is recommended as recommended by the
American Veterinary Medical Association and its Council on Biologic and
Therapeutic Agents, the attending veterinarian should determine the
frequency of revaccination based on the animal's lifestyle and risk of
exposure.4
PRECAUTIONS:
1. Store at 2°-7°C. Prolonged exposure to higher
temperatures and/or direct sunlight may adversely affect potency. Do not
freeze.
2. Use entire contents when first opened.
3. Sterilized syringes and needles should be used to
administer this vaccine. Do not sterilize with chemicals because traces
of disinfectant may inactivate the vaccine.
4. Burn containers and all unused contents.
5. Contains gentamicin as preservative.
6. Vaccination of pregnant queens should be avoided.
7. As with many vaccines, anaphylaxis may occur after
use. Initial antidote of epinephrine is recommended and should be
followed with appropriate supportive therapy.
8. This product has been shown to be efficacious in
healthy animals. A protective immune response may not be elicited if
animals are incubating an infectious disease, are malnourished or
parasitized, are stressed due to shipment or environmental conditions,
are otherwise immunocompromised, or the vaccine is not administered in
accordance with label directions.
REFERENCES:
1. Tizard I, Ni Y: Use of serologic testing to assess
immune status of companion animals. JAVMA 213:54-60,
1998.
2. Schultz RD: Current and future canine and feline
vaccination programs. Vet Med 93(3):233-254,
1998.
3. Study 2184Z-60-01-003, Pfizer Animal Health
4. American Veterinary Medical Association, Position
Statements on Biologics, June 2001.
Technical inquiries should be directed to Pfizer Animal
Health Veterinary Services, (800) 366-5288 (USA), (800) 461-0917
(Canada).
For veterinary use only
U.S. Veterinary License No. 189
Pfizer Animal Health, Exton, PA
19341, USA
Div. of Pfizer Inc, NY, NY 10017
75-0240-01
25 x 1-dose vials
NAC No.: 36901871