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Pneumovax 23 (Pneumococcal Vaccine Polyvalent) is a vaccine that helps protect against serious infection, such as ear infection, sinus infection, pneumonia, blood infection (bacteremia), and meningitis (infection of the covering of the brain) due to the bacteria Streptococcus pneumoniae. Pneumovax 23 vaccine is important for preventing infection in individuals at risk, including those with heart disease, lung disease, liver disease, kidney disease, diabetes, alcoholism, cirrhosis, spleen problems, sickle cell anemia, HIV, certain cancers, adults over 65 years of age.
What are side effects of Pneumovax 23?
Common side effects of Pneumovax 23 include:
injection site reactions (pain, soreness, warmth, redness, swelling, tenderness, hard lump),
muscle or joint aches or pain,
fever,
chills,
headache,
nausea,
vomiting,
stiffness of the arm or the leg where the vaccine was injected,
weakness,
fatigue, or
skin rash.
DESCRIPTION
PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).
PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary.
The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex.
Indications & Dosage
INDICATIONS
Indications And Use
PNEUMOVAX® 23 is a vaccine indicated for active
immunization for the prevention of pneumococcal disease caused by the 23
serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A,
12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is
approved for use in persons 50 years of age or older and persons aged ≥ 2
years who are at increased risk for pneumococcal disease.
Limitations Of Use
PNEUMOVAX 23 will not prevent disease caused by capsular
types of pneumococcus other than those contained in the vaccine.
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration. If either of
these two conditions exists, the vaccine should not be administered.
Do not mix PNEUMOVAX 23 with other vaccines in the same
syringe or vial.
Use a separate sterile syringe and needle for each
individual patient to prevent transmission of infectious agents from one person
to another.
Single-Dose and Multidose Vials
Withdraw 0.5 mL from the vial using a sterile needle and
syringe free of preservatives, antiseptics, and detergents.
Single-Dose, Prefilled Syringe
The package does not contain a needle. Attach a sterile
needle to the prefilled syringe by twisting in a clockwise direction until the
needle fits securely on the syringe.
Administration
Administer PNEUMOVAX 23 intramuscularly or subcutaneously
into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or
intradermally.
Single-Dose and Multidose Vials
Administer a single 0.5-mL dose of PNEUMOVAX 23 using a
sterile needle and syringe.
Single-Dose, Prefilled Syringe
Administer the entire contents of the single-dose,
prefilled syringe per standard protocol using a sterile needle.
Revaccination
The Advisory Committee on Immunization Practices (ACIP)
has recommendations for revaccination against pneumococcal disease for persons
at high risk who were previously vaccinated with PNEUMOVAX 23. Routine
revaccination of immunocompetent persons previously vaccinated with a 23-valent
vaccine, is not recommended.1,2
HOW SUPPLIED
Dosage Forms And Strengths
PNEUMOVAX 23 is a clear, sterile solution supplied in a
(0.5-mL dose) single-dose vial, a 5-dose vial, and a single-dose, prefilled
syringe. [See DESCRIPTION and Storage and
Handling]
PNEUMOVAX 23 is supplied as follows:
NDC 0006-4739-00 — one 5-dose vial, color coded
with a purple cap and stripe on the vial labels and cartons.
NDC 0006-4943-00 — a box of 10 single-dose vials,
color coded with a purple cap and stripe on the vial labels and cartons.
NDC 0006-4837-03 — a box of 10 single-dose,
pre-filled Luer-Lok™ syringes with tip caps, color coded with a violet plunger
rod and purple stripe on the syringe labels and cartons.
Storage And Handling
Store at 2-8°C (36-46°F).
All vaccine must be discarded after the expiration date.
The vial stoppers, syringe plunger stopper and syringe
tip cap are not made with natural rubber latex.
REFERENCES
1. Centers for Disease Control and Prevention. Prevention
of Pneumococcal Disease. Recommendations of the Advisory Committee on
Immunization Practices (ACIP). MMWR. 46(No. RR-8): 1-25, 1997. Available from:
http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf
2. Centers for Disease Control and Prevention. Prevention
of Pneumococcal Disease Among Infants and Children --- Use of 13-Valent
Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide
Vaccine, MMWR 59(RR11): 1-18, 2010.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm?s_cid=rr5911a1_e
Manuf. and Dist. by: Merck Sharp & Dohme Corp, a
subsidiary of MERCK & CO, INC., Whitehouse Station, NJ 08889, USA
Side Effects & Drug Interactions
SIDE EFFECTS
The most common adverse reactions, reported in > 10% of
subjects vaccinated with PNEUMOVAX 23 in clinical trials were: injection-site
pain/soreness/tenderness (60.0%), injection-site swelling/induration (20.3%),
headache (17.6%), injection-site erythema (16.4%), asthenia/fatigue (13.2%),
and myalgia (11.9%). [See Clinical Trials Experience]
Clinical Trials Experience
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
vaccine cannot be directly compared to rates in the clinical trials of another
vaccine and may not reflect the rates observed in practice.
In a randomized, double-blind, placebo-controlled
crossover clinical trial, subjects were enrolled in four different cohorts
defined by age (50-64 years of age and ≥ 65 years of age) and vaccination
status (no pneumococcal vaccination or receipt of a pneumococcal polysaccharide
vaccine 3-5 years prior to the study). Subjects in each cohort were randomized
to receive intramuscular injections of PNEUMOVAX 23 followed by placebo (saline
containing 0.25% phenol), or placebo followed by PNEUMOVAX 23, at 30-day (±7
days) intervals. The safety of an initial vaccination (first dose) was compared
to revaccination (second dose) with PNEUMOVAX 23 for 14 days following each vaccination.
All 1008 subjects (average age, 67 years; 49% male and
51% female; 91% Caucasian, 4.7% African-American, 3.5% Hispanic, and 0.8%
Other) received placebo injections.
Initial vaccination was evaluated in a total of 444
subjects (average age 65 years; 32% male and 68% female; 93% Caucasian, 3.2%
African-American, 3.4% Hispanic, and 1.1% Other).
Revaccination was evaluated in 564 subjects (average age
69 years; 53% male and 47% female; 90% Caucasian, 3.5% Hispanic, 6.0%
African-American, and 0.5% Other).
Serious Adverse Experiences
In this study, 10 subjects had serious adverse
experiences within 14 days of vaccination: 6 who received PNEUMOVAX 23 and 4
who received placebo. Serious adverse experiences within 14 days after
PNEUMOVAX 23 included angina pectoris, heart failure, chest pain, ulcerative
colitis, depression, and headache/tremor/stiffness/sweating. Serious adverse
experiences within 14 days after placebo included myocardial infarction
complicated with heart failure, alcohol intoxication, angina pectoris, and
edema/urinary retention/heart failure/diabetes.
Five subjects reported serious adverse experiences that
occurred outside the 14-day follow-up window: 3 who received PNEUMOVAX 23 and 2
who received placebo. Serious adverse experiences after PNEUMOVAX 23 included
cerebrovascular accident, lumbar radiculopathy, and pancreatitis/myocardial
infarction resulting in death. Serious adverse experiences after placebo
included heart failure and motor vehicle accident resulting in death.4
Solicited and Unsolicited Reactions
Table 1 presents the adverse event rates for all
solicited and unsolicited reactions reported in ≥ 1% in any group in this
study, without regard to causality.
The most common local adverse reactions reported at the
injection site after initial vaccination with PNEUMOVAX 23 were
pain/tenderness/soreness (60.0%), swelling/induration (20.3%), and erythema
(16.4%). The most common systemic adverse experiences were headache (17.6%),
asthenia/fatigue (13.2%), and myalgia (11.9%).
The most common local adverse reactions reported at the
injection site after revaccination with PNEUMOVAX 23 were
pain/soreness/tenderness (77.2%), swelling (39.8%), and erythema (34.5%). The
most common systemic adverse reactions with revaccination were headache
(18.1%), asthenia/fatigue (17.9%), and myalgia (17.3%). All of these adverse
reactions were reported at a rate lower than 10% after receiving a placebo
injection.
Table 1: Incidence of Injection-Site and Systemic
Complaints in Adults ≥ 50 Years of Age Receiving Their First (Initial) or
Second (Revaccination) Dose of PNEUMOVAX 23 (Pneumococcal Polysaccharide
Vaccine, 23 Valent) or Placebo Occurring at ≥ 1% in Any Group
PNEUMOVAX 23 Initial Vaccination
N=444
PNEUMOVAX 23 Revaccination*
N=564
Placebo Injection†
N=1008
Number Followed for Safety
438
548
984*
AE Rate
AE Rate
AE Rate
Injection-Site Complaints
Solicited Events
Pain/Soreness/ Tenderness
60.0%
77.2%
7.7%
Swelling/ Induration
20.3%
39.8%
2.8%
Erythema
16.4%
34.5%
3.3%
Unsolicited Events
Ecchymosis
0%
1.1%
0.3%
Pruritus
0.2%
1.6%
0.0%
Systemic Complaints
Solicited Events
Asthenia/Fatigue
13.2%
17.9%
6.7%
Chills
2.7%
7.8%
1.8%
Myalgia
11.9%
17.3%
3.3%
Headache
17.6%
18.1%
8.9%
Unsolicited Events
Fever§
1.4%
2.0%
0.7%
Diarrhea
1.1%
0.7%
0.5%
Dyspepsia
1.1%
1.1%
0.9%
Nausea
1.8%
1.8%
0.9%
Back Pain
0.9%
0.9%
1.0%
Neck Pain
0.7%
1.5%
0.2%
Upper Respiratory Infection
1.8%
2.6%
1.8%
Pharyngitis
1.1%
0.4%
1.3%
*Subjects receiving their second dose of pneumococcal
polysaccharide vaccine as PNEUMOVAX 23 approximately 3-5 years after their
first dose.
†Subjects receiving placebo injection from this study combined over periods.
‡The number of subjects receiving placebo followed for injection-site
complaints. The corresponding number of subjects followed for systemic
complaints was 981.5
§Fever events include subjects who felt feverish in addition to subjects with
elevated temperature.
In this clinical study an increased rate of local
reactions was observed with revaccination at 3-5 years following initial
vaccination.
For subjects aged 65 years or older, injection-site
adverse reaction rate was higher following revaccination (79.3%) than following
initial vaccination (52.9%). The proportion of subjects reporting injection
site discomfort that interfered with or prevented usual activity or injection
site induration ≥ 4 inches was higher following revaccination (30.6%) than
following initial vaccination (10.4%). Injection site reactions typically
resolved by 5 days following vaccination.
For subjects aged 50-64 years, the injection-site adverse
reaction rate for revaccinees and initial vaccinees was similar (79.6% and
72.8% respectively).
The rate of systemic adverse reactions was similar among
both initial vaccinees and revaccinees within each age group. The rate of
vaccine-related systemic adverse reactions was higher following revaccination
(33.1%) than following initial vaccination (21.7%) in subjects 65 years of age
or older, and was similar following revaccination (37.5%) and initial
vaccination (35.5%) in subjects 50-64 years of age. The most common systemic
adverse reactions reported after PNEUMOVAX 23 were as follows: asthenia/fatigue,
myalgia and headache.
Regardless of age, the observed increase in post
vaccination use of analgesics ( ≤ 13% in the revaccinees and ≤ 4% in
the initial vaccinees) returned to baseline by day 5.
Post-Marketing Experience
The following list of adverse reactions includes those
identified during post approval use of PNEUMOVAX 23. Because these reactions
are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or their causal relationship to
product exposure.
General Disorders And Administration Site Conditions
CellulitisMalaise
Fever ( > 102°F)
Warmth at the injection site
Decreased limb mobility
Peripheral edema in the injected extremity
In a randomized clinical study, a reduced immune response
to ZOSTAVAX® as measured by gpELISA was observed in individuals who received
concurrent administration of PNEUMOVAX 23 and ZOSTAVAX compared with
individuals who received these vaccines 4 weeks apart. Consider administration
of the two vaccines separated by at least 4 weeks. [See Clinical Studies]
Limited safety and immunogenicity data from clinical
trials are available on the concurrent administration of PNEUMOVAX 23 and
vaccines other than ZOSTAVAX.
Persons With Severely Compromised Cardiovascular Or Pulmonary
Function
Caution and appropriate care should be exercised in
administering PNEUMOVAX 23 to individuals with severely compromised
cardiovascular and/or pulmonary function in whom a systemic reaction would pose
a significant risk.
Use Of Antibiotic Prophylaxis
This vaccine does not replace the need for penicillin (or
other antibiotic) prophylaxis against pneumococcal infection. In patients who
require penicillin (or other antibiotic) prophylaxis against pneumococcal
infection, such prophylaxis should not be discontinued after vaccination with
PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing
pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF)
leakage resulting from congenital lesions, skull fractures, or neurosurgical
procedures.
Patient Counseling Information
Advise the patient to read the FDA-approved patient
labeling (PATIENT INFORMATION).
Inform the patient, parent or guardian of the benefits and
risks associated with vaccination.
Tell the patient, parent or guardian that vaccination
with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
Provide the patient, parent or guardian with the vaccine
information statements required by the National Childhood Vaccine Injury Act of
1986, with each immunization.
Instruct the patient, parent or guardian to report any
serious adverse reactions to their health care provider who in turn should
report such events to the vaccine manufacturer or the U.S. Department of Health
and Human Services through the Vaccine Adverse Event Reporting System (VAERS),
1-800-822-7967, or report online at www.vaers.hhs.gov. 10
REFERENCES
10. Vaccine Adverse Event Reporting System - United
States, MMWR. 39(41): 730-33, October 19, 1990.
Use In Specific Populations
Pregnancy
Pregnancy Category C: Animal reproduction studies
have not been conducted with PNEUMOVAX 23. It is also not known whether
PNEUMOVAX 23 can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. PNEUMOVAX 23 should be given to a pregnant woman
only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when PNEUMOVAX 23 is administered to a nursing woman.
Pediatric Use
PNEUMOVAX 23 is not approved for use in children less
than 2 years of age. Children in this age group do not develop an effective
immune response to the capsular types contained in this polysaccharide vaccine.
The ACIP has recommendations for use of PNEUMOVAX 23 in
children 2 years of age or older, who have previously received pneumococcal
vaccines, and who are at increased risk for pneumococcal disease.2
Geriatric Use
In one clinical trial of PNEUMOVAX 23, conducted
post-licensure, a total of 629 subjects who were aged ≥ 65 years and 201
subjects who were aged ≥ 75 years were enrolled.
In this trial, the safety of PNEUMOVAX 23 in adults 65
years of age and older (N=629) was compared to the safety of PNEUMOVAX 23 in
adults 50 to 64 years of age (N=379). The subjects in this study had underlying
chronic illness but were in stable condition; at least 1 medical condition at
enrollment was reported by 86.3% of subjects who were 50 to 64 years old, and
by 96.7% of subjects who were 65 to 91 years old. The rate of vaccine-related
systemic adverse experiences was higher following revaccination (33.1%) than
following primary vaccination (21.7%) in subjects ≥ 65 years of age, and
was similar following revaccination (37.5%) and primary vaccination (35.5%) in
subjects 50 to 64 years of age.
Since elderly individuals may not tolerate medical
interventions as well as younger individuals, a higher frequency and/or a
greater severity of reactions in some older individuals cannot be ruled out.
Post-marketing reports have been received in which some
elderly individuals had severe adverse experiences and a complicated clinical
course following vaccination. Some individuals with underlying medical
conditions of varying severity experienced local reactions and fever associated
with clinical deterioration requiring hospital care.
Immunocompromised Individuals
Persons who are immunocompromised, including persons
receiving immunosuppressive therapy, may have a diminished immune response to
PNEUMOVAX 23.
REFERENCES
2. Centers for Disease Control and Prevention. Prevention
of Pneumococcal Disease Among Infants and Children --- Use of 13-Valent
Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide
Vaccine, MMWR 59(RR11): 1-18, 2010.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm?s_cid=rr5911a1_e
Overdosage & Contraindications
OVERDOSE
No information provided.
CONTRAINDICATIONS
Hypersensitivity
Do not administer PNEUMOVAX 23 to individuals with a
history of anaphylactic/anaphylactoid or severe allergic reaction to any
component of the vaccine. [SeeDESCRIPTION]
Clinical Pharmacology
Mechanism Of Action
PNEUMOVAX 23 induces type-specific antibodies that
enhance opsonization, phagocytosis, and killing of pneumococci by leukocytes
and other phagocytic cells. The levels of antibodies that correlate with
protection against pneumococcal disease have not been clearly defined.
Clinical Studies
Effectiveness
The protective efficacy of pneumococcal vaccines
containing six (types 1, 2, 4, 8, 12F, and 25) or twelve (types 1, 2, 3, 4, 6A,
8, 9N, 12F, 25, 7F, 18C, and 46) capsular polysaccharides was investigated in
two controlled studies in South Africa in male novice gold miners ranging in
age from 16 to 58 years, in whom there was a high attack rate for pneumococcal
pneumonia and bacteremia.4 In both studies, participants in the
control groups received either meningococcal polysaccharide serogroup A vaccine
or saline placebo. In both studies, attack rates for vaccine type pneumococcal
pneumonia were observed for the period from 2 weeks through about 1 year after
vaccination. Protective efficacy was 76% and 92%, respectively, for the 6- and
12-valent vaccines, for the capsular types represented.
Three similar studies in South African young adult male
novice gold miners were carried out by Dr. R. Austrian and associates5
using similar pneumococcal vaccines prepared for the National Institute of
Allergy and Infectious Diseases, with pneumococcal vaccines containing a
6-valent formulation (types 1, 3, 4, 7, 8, and 12) or a 13-valent formulation
(types 1, 2, 3, 4, 6, 7, 8, 9, 12, 14, 18, 19, and 25) capsular
polysaccharides. The reduction in pneumococcal pneumonia caused by the capsular
types contained in the vaccines was 79%. Reduction in type-specific
pneumococcal bacteremia was 82%.
A prospective study in France found a pneumococcal
vaccine containing fourteen (types 1, 2, 3, 4, 6A, 7F, 8, 9N, 12F, 14, 18C,
19F, 23F, and 25) capsular polysaccharides to be 77% (95%CI: 51% to 89%)
effective in reducing the incidence of pneumonia among male and female nursing
home residents with a mean age of 74 (standard deviation of 4 years).6
In a study using a pneumococcal vaccine containing eight
(types 1, 3, 6, 7, 14, 18, 19, and 23) capsular polysaccharides, vaccinated
children and young adults aged 2 to 25 years who had sickle cell disease,
congenital asplenia, or undergone a splenectomy experienced significantly less
bacteremic pneumococcal disease than patients who were not vaccinated.7
In the United States, one post-licensure randomized
controlled trial, in the elderly or patients with chronic medical conditions
who received a 14-valent pneumococcal polysaccharide vaccine (types 1, 2, 3, 4,
6A, 8, 9N, 12F, 14, 19F, 23F, 25, 7F, and 18C), did not support the efficacy of
the vaccine for nonbacteremic pneumonia.8
A retrospective cohort analysis study based on the U.S.
Centers for Disease Control and Prevention (CDC) pneumococcal surveillance
system, showed 57% (95%CI: 45% to 66%) overall protective effectiveness against
invasive infections caused by serotypes included in PNEUMOVAX 23 in persons
≥ 6 years of age, 65 to 84% effectiveness among specific patient groups
(e.g., persons with diabetes mellitus, coronary vascular disease, congestive
heart failure, chronic pulmonary disease, and anatomic asplenia) and 75% (95%CI:
57% to 85%) effectiveness in immunocompetent persons aged ≥ 65 years of
age. Vaccine effectiveness could not be confirmed for certain groups of
immunocompromised patients.9
Immunogenicity
The levels of antibodies that correlate with protection against
pneumococcal disease have not been clearly defined.
Antibody responses to most pneumococcal capsular types
are generally low or inconsistent in children less than 2 years of age.
Concomitant Administration With Other Vaccines
In a double-blind, controlled clinical trial, 473 adults,
60 years of age or older, were randomized to receive ZOSTAVAX and PNEUMOVAX 23
concomitantly (N=237), or PNEUMOVAX 23 alone followed 4 weeks later by ZOSTAVAX
alone (N=236). At four weeks postvaccination, the varicella-zoster virus (VZV)
antibody levels following concomitant use were significantly lower than the VZV
antibody levels following nonconcomitant administration (GMTs of 338 vs. 484
gpELISA units/mL, respectively; GMT ratio = 0.70 (95% CI: [0.61, 0.80]).
Limited safety and immunogenicity data from clinical
trials are available on the concurrent administration of PNEUMOVAX 23 and
vaccines other than ZOSTAVAX.
6. Gaillat, J.; Zmirou, D.; Mallaret, M.R.: Essai clinique
du vaccin antipneuomococcique chez des personnes agees vivant en institution,
Rev. Epidemiol. Sante Publique. 33: 437-44, 1985.
7. Ammann, A.J.; Addiego, J.; Wara, D.W.; Lubin, B.;
Smith, W.B.; Mentzer, W.C.: Polyvalent pneumococcal-polysaccharide immunization
of patients with sickle-cell anemia and patients with splenectomy, N. Engl. J.
Med. 297: 897-900, 1977.
8. Simberkoff, M.S.; Cross, A.P.; Al-Ibrahim, M.:
Efficacy of pneumococcal vaccine in high risk patients: results of a Veterans
Administration cooperative study, N. Engl. J. Med. 315: 1318-27, 1986.
9. Butler, J.C.; Breiman, R.F.; Campbell, J.F.; Lipman,
H.B.; Broome, C.V.; Facklam, R.R.: Pneumococcal polysaccharide vaccine
efficacy. An evaluation of current recommendations, JAMA. 270: 1826-31, 1993.
Medication Guide
PATIENT INFORMATION
No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.
