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
Merck Sharp & Dohme Corp.
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.
PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
For intramuscular or subcutaneous injection only.
- 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.
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.
Administer PNEUMOVAX 23 intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.
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.
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.
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).]
Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.
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.
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.
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).]
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.
The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 for the first time in a clinical trial, 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).]
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.
Primary Vaccination and Revaccination with PNEUMOVAX 23 in Adults 50 Years of Age or Older
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.
|PNEUMOVAX 23Initial Vaccination||PNEUMOVAX 23Revaccination *||Placebo Injection †|
|Number Followed for Safety||438||548||984‡|
|AE Rate||AE Rate||AE Rate|
|Upper Respiratory Infection||1.8%||2.6%||1.8%|
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.
Sequential Administration of Prevnar 13 and PNEUMOVAX 23
In a randomized, double-blind, placebo-controlled, multicenter study, healthy adults, 50 years of age and older, received Prevnar 13 followed by PNEUMOVAX 23 either 8 weeks later (Group 1) or 26 weeks later (Group 2). Placebo was administered instead of PNEUMOVAX 23 at 26 weeks (Group 1) or 8 weeks (Group 2). Solicited injection site adverse reactions were evaluated during Days 1 through 5 postvaccination. Solicited systemic adverse reactions and any other adverse reactions were evaluated during Days 1 through 14 postvaccination, and any serious adverse events (SAEs) were collected throughout the study period (through Week 30). [See Clinical Studies (14.2).]
Overall, subjects were a mean age of 64.2 years (range: 50 to 97 years). There were more females (n=219, 54.8%) than males (n=181, 45.3%). By race, 84.8% of subjects were White, 9.3% were Black or African-American, and 6.1% were other racial groups; the majority of subjects were not Hispanic or Latino (n=322, 80.5%).
Serious Adverse Reactions
There were 24 SAEs reported in 20 subjects (n=9 [4.5%] Group 1; n=11 [5.5%] Group 2). No SAEs were considered related to vaccination.
Solicited Adverse Reactions
Solicited injection site adverse reactions that occurred during Days 1 through 5 postvaccination with PNEUMOVAX 23, solicited systemic adverse reactions that occurred during Days 1 through 14, and fever that occurred during Days 1 through 5 postvaccination with PNEUMOVAX 23 are presented in Table 2. In this study, 81.4% of subjects in Group 1 and 64.0% of subjects in Group 2 reported at least 1 injection site adverse reaction from Days 1 through 5 postvaccination with PNEUMOVAX 23, and 64.9% of subjects in Group 1 and 54.9% of subjects in Group 2 reported at least 1 systemic adverse reaction from Days 1 through 14 postvaccination with PNEUMOVAX 23.
|Group 1*(Prevnar 13 -> PNEUMOVAX 23 -> Placebo)||Group 2†(Prevnar 13 -> Placebo -> PNEUMOVAX 23)|
|Every subject is counted a single time for each applicable row and column.|
|A specific adverse reaction appears in this table only if its incidence in one or more of the columns meets the incidence criterion in the table title, after rounding.|
|Injection Site Adverse Reactions|
|Subjects in population with follow-up||188||164|
|Any injection site reaction||153||(81.4)||105||(64.0)|
|Any Injection site pain ‡||149||(79.3)||105||(64.0)|
|Any Injection site swelling||95||(50.5)||48||(29.3)|
|0 to <2.5 cm||28||(14.9)||19||(11.6)|
|≥2.5 to <5.1 cm||20||(10.6)||9||(5.5)|
|≥5.1 to <7.6 cm||20||(10.6)||10||(6.1)|
|≥7.6 to <10.2 cm||15||(8.0)||2||(1.2)|
|≥10.2 cm §||12||(6.4)||8||(4.9)|
|Any Injection site erythema||78||(41.5)||48||(29.3)|
|0 to <2.5 cm||26||(13.8)||20||(12.2)|
|≥2.5 to <5.1 cm||12||(6.4)||13||(7.9)|
|≥5.1 to <7.6 cm||12||(6.4)||6||(3.7)|
|≥7.6 to <10.2 cm||7||(3.7)||3||(1.8)|
|Unknown [missing data]||2||(1.1)||0||(0.0)|
|Systemic Adverse Reactions|
|Subjects in population with follow-up||188||164|
|Any systemic adverse reaction||122||(64.9)||90||(54.9)|
|Subjects with temperature data ¶||185||161|
|Temperature ≥ 100.4°F||1||(0.5)||0||(0.0)|
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