| Important
CDC vaccination and revaccination guidelines
for
pneumococcal disease.
Whom should you vaccinate?
The CDCa published ACIPb recommendations for pneumococcal
vaccination.c
aCenters for Disease
Control and Prevention.
bAdvisory Committee on Immunization Practices.
cFor detailed information about the ACIP recommendations, please see Centers for Disease Control and Prevention (CDC).
Prevention of pneumococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP).
MMWR. 1997;46(RR-08):1–24.
dIncluding patients who have undergone organ or bone
marrow transplant and those receiving immunosuppressive
chemotherapy. PNEUMOVAX®23
(Pneumococcal Vaccine Polyvalent) is indicated for vaccination against pneumococcal
disease caused by those pneumococcal types included
in the vaccine.
Select Safety Information
PNEUMOVAX 23 is contraindicated in individuals who
are hypersensitive to any component of the vaccine.
The most common adverse experiences reported with PNEUMOVAX 23 in clinical
trials were: Local reaction at injection site including soreness, erythema,
warmth, swelling and induration, and fever <102°F.
In
post-marketing experience, injection site cellulitis-like
reactions were reported rarely;
between 1989 and
2002, when approximately 43 million doses were
distributed, the annual reporting rate was <2/100,000
doses. These cellulitis-like reactions occurred
with initial
and repeat vaccination at a median onset time
of 2 days after vaccine administration.
Vaccination
with PNEUMOVAX 23 may not offer 100% protection
from pneumococcal infection.
Safety and effectiveness
in children <2 years
of age have not been established. Accordingly,
PNEUMOVAX 23 is not recommended in this age group.
If the vaccine is used
in persons receiving immunosuppressive therapy, the expected serum antibody
response may not be obtained and potential impairment
of future
immune responses to pneumococcal antigens
may occur.
PNEUMOVAX 23 will not prevent disease caused
by capsular types of pneumococcus other
than those
contained
in the vaccine.
When is the right time for revaccination?
The CDCa published ACIPb recommendations for pneumococcal
revaccination for the following patients:
aCenters for Disease Control and Prevention.
bAdvisory Committee on Immunization Practices.
cIncluding sickle cell disease and splenectomy.
dIncluding congestive heart failure and cardiomyopathies.
eIncluding chronic obstructive pulmonary disease and emphysema.
fIncluding cirrhosis. In a clinical trial, an increased
rate of local reactions has been observed with revaccination at 3 to 5
years
following primary vaccination. For subjects aged >65 years, it was reported
that the overall injection-site adverse experiences rate was higher following
revaccination (79.3%) than following
primary vaccination
(52.9%). For subjects aged 50 to 64 years, the reported overall injection-site
adverse experiences rate for re-vaccinees and primary vaccinees were similar
(79.6% and 72.8%, respectively).
Because data are insufficient concerning
the safety of pneumococcal vaccine when administered three or more times,
revaccination following a second dose is not routinely recommended.
Any
febrile respiratory illness or other active infection is reason for delaying
use of PNEUMOVAX 23, except when, in the opinion of the physician,
withholding the agent entails even greater risk.
Before administering PNEUMOVAX 23, please read the Prescribing
Information.
PNEUMOVAX 23 is a registered trademark of Merck & Co., Inc.
Reference: 1. Centers
for Disease Control and Prevention. Prevention of pneumococcal disease.
Recommendations of
the Advisory Committee on Immunization
Practices (ACIP). MMWR. 1997;46(RR–8):1–24.
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