Vaccine Information: PNEUMOVAX 23

PNEUMOVAX 23- streptococcus pneumoniae type 1 capsular polysaccharide antigen, streptococcus pneumoniae type 2 capsular polysaccharide antigen, streptococcus pneumoniae type 3 capsular polysaccharide antigen, streptococcus pneumoniae type 4 capsular polysaccharide antigen, streptococcus pneumoniae type 5 capsular polysaccharide antigen, streptococcus pneumoniae type 6b capsular polysaccharide antigen, streptococcus pneumoniae type 7f capsular polysaccharide antigen, streptococcus pneumoniae type 8 capsular polysaccharide antigen, streptococcus pneumoniae type 9n capsular polysaccharide antigen, streptococcus pneumoniae type 9v capsular polysaccharide antigen, streptococcus pneumoniae type 10a capsular polysaccharide antigen, streptococcus pneumoniae type 11a capsular polysaccharide antigen, streptococcus pneumoniae type 12f capsular polysaccharide antigen, streptococcus pneumoniae type 14 capsular polysaccharide antigen, streptococcus pneumoniae type 15b capsular polysaccharide antigen, streptococcus pneumoniae type 17f capsular polysaccharide antigen, streptococcus pneumoniae type 18c capsular polysaccharide antigen, streptococcus pneumoniae type 19f capsular polysaccharide antigen, streptococcus pneumoniae type 19a capsular polysaccharide antigen, streptococcus pneumoniae type 20 capsular polysaccharide antigen, streptococcus pneumoniae type 22f capsular polysaccharide antigen, streptococcus pneumoniae type 23f capsular polysaccharide antigen and streptococcus pneumoniae type 33f capsular polysaccharide antigen injection, solution
A-S Medication Solutions

1 INDICATIONS AND USAGE

1.1 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.

1.2 Limitations of Use

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

2 DOSAGE AND ADMINISTRATION

For intramuscular or subcutaneous injection only.

2.1 Preparation

  • 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 Vial
    Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
    Single-Dose, Prefilled SyringeThe 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.

2.2 Administration

Administer PNEUMOVAX 23 intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.

Single-Dose Vial

Administer a single 0.5-mL dose of PNEUMOVAX 23 using a sterile needle and syringe. Discard vial after use.

Single-Dose, Prefilled Syringe

Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle. Discard syringe after use.

2.3 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.

3 DOSAGE FORMS AND STRENGTHS

PNEUMOVAX 23 is a clear, sterile solution supplied in a (0.5-mL dose) single-dose vial and a single-dose, prefilled syringe. [See Description (11) and How Supplied/Storage and Handling (16).]

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Do not administer PNEUMOVAX 23 to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine. [See Description (11).]

5 WARNINGS AND PRECAUTIONS

5.1 Persons with Moderate or Severe Acute Illness

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

5.2 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.

5.3 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.

5.4 Persons with Altered Immunocompetence

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23. [See Use in Specific Populations (8.6).]

5.5 Persons with Chronic Cerebrospinal Fluid Leakage

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.

6 ADVERSE REACTIONS

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 Adverse Reactions (6.1).]

6.1 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.

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 23Initial Vaccination PNEUMOVAX 23Revaccination * Placebo Injection
N=444 N=564 N=1008
*
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.
§
Fever events include subjects who felt feverish in addition to subjects with elevated temperature.
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%

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.

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