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PNEUMOVAX® 23
(pneumococcal vaccine polyvalent) Injection
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.
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.
Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
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.
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.
Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle.
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
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.
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
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]
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).
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
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.
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.
Cellulitis Malaise
Fever ( > 102°F)
Warmth at the injection site
Decreased limb mobility
Peripheral edema in the injected extremity
Nausea
Vomiting
Lymphadenitis
Lymphadenopathy
Thrombocytopenia in patients with stabilized idiopathic
thrombocytopenic purpura3
Hemolytic anemia in patients who have had other
hematologic disorders
Leukocytosis
Anaphylactoid reactions
Serum Sickness
Angioneurotic edema
Arthralgia
Arthritis
Paresthesia
Radiculoneuropathy
Guillain-Barré syndrome
Febrile convulsion
Rash
Urticaria
Cellulitis-like reactions
Erythema multiforme
Increased serum C-reactive protein
REFERENCES
3. Kelton, J.G.: Vaccination-associated relapse of immune thrombocytopenia, JAMA. 245(4): 369-371, 1981.
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.
Included as part of the PRECAUTIONS section.
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]
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.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
REFERENCES
10. Vaccine Adverse Event Reporting System - United States, MMWR. 39(41): 730-33, October 19, 1990.
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.
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.
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
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.
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
No information provided.
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]
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.
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
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.
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.
REFERENCES
4. Smit, P.; Oberholzer, D.; Hayden-Smith, S.; Koornhof, H.J.; Hilleman, M.R.: Protective efficacy of pneumococcal polysaccharide vaccines, JAMA. 238: 2613-2616, 1977.
5. Austrian, R.; Douglas, R.M.; Schiffman, G.; Coetzee, A.M.; Koornhof, H.J.; Hayden-Smith, S.; Reid, R.D.W.: Prevention of pneumococcal pneumonia by vaccination, Trans. Assoc. Am. Physicians. 89: 184-194, 1976.
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.
No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.
