Pneumococcal vaccine, polyvalent

Dosage Forms & Strengths

vaccine

• 0.5mL (1 dose)

Pneumococcal Disease Prevention

Indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine

0.5 mL SC/IM

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

ACIP Guidelines, Routine Immunization for Immunocompetent Adults

All patients ≥65 years: ACIP recommends routine vaccination with both PPSV23 (23-valent pneumococcal polysaccharide vaccine) and PCV13 (13-valent pneumococcal conjugate vaccine)

MMWR 2015 Sep 4:64(34);944-947

Pneumococcal vaccine-naïve

• Administer PCV13 first, and then PPSV23 ≥1 yr later

Previous vaccination with PPSV23

• A dose of PCV13 should be given ≥1 yr after receipt of the most recent PPSV23 dose
• For those whom an additional dose of PPSV23 is indicated, this subsequent PPSV23 dose should be given 6-12 months after PCV13 and ≥5 yr after the most recent dose of PPSV23

ACIP Guidelines, Immunocompromising Conditions

PCV13 recommended in addition to PPSV23 for adults ≥19 yr with immunocompromising conditions (including chronic renal failure and nephrotic syndrome), functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants who have not previously received PCV13 or PPSV23 (MMWR 2012 Oct 12;61[40]:816-819)

Note: minimum interval between PCV13 and PPSV23 is 8 wk for immunocompromised adults

Dosage Forms & Strengths

vaccine

• 0.5mL (1 dose)

Pneumococcal Disease Prevention

Indicated for children with high risk conditions including chronic heart or lung disease, diabetes mellitus, cerebrospinal fluid leaks, cochlear implants, anatomic or functional asplenia (including sickle cell disease), or immunocompromised conditions

Do not confuse with routine childhood pneumococcal vaccine PCV13

<2 years: Safety and efficacy not established

≥2 years: 0.5 mL SC/IM for high risk conditions (plus PCV13)

All recommended PCV13 doses should be administered prior to PPSV23 vaccination if possible

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

ACIP Guidelines, Aged 2-5 Years

Any of the following conditions:

Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure)

Chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy)

Diabetes mellitus Cerebrospinal fluid leak

Cochlear implant

Sickle cell disease and other hemoglobinopathies

Anatomic or functional asplenia

HIV infection

Chronic renal failure

Nephrotic syndrome

Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; solid organ transplantation; or congenital immunodeficiency

Dosage for high risk 2-5 years olds

• 1. Administer 1 dose of PCV13 if 3 doses of PCV (7- or 13-valent) were received previously
• 2. Administer 2 doses of PCV (7- or 13-valent) at least 8 weeks apart if fewer than 3 doses of PCV13 were received previously
• 3. Administer 1 supplemental dose of PCV13 if 4 doses of PCV7 or other age-appropriate complete PCV7 series was received previously
• 4. The minimum interval between doses of PCV (PCV7 or PCV13) is 8 wk
• 5. For children with no history of PPSV23 vaccination, administer PPSV23 at least 8 wk after the most recent dose of PCV13

ACIP Guidelines, Aged 6-18 Years

Any of the following conditions:

Cerebrospinal fluid leak

Cochlear implant

Sickle cell disease and other hemoglobinopathies

Anatomic or functional asplenia

Congenital or acquired immunodeficiencies

HIV infection

Chronic renal failure

Nephrotic syndrome

Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; generalized malignancy; solid organ transplantation; or multiple myeloma

1. If neither PCV13 nor PPSV23 has been received previously, administer 1 dose of PCV13 now and 1 dose of PPSV23 at least 8 wk later

2. If PCV13 has been received previously but PPSV23 has not, administer 1 dose of PPSV23 at least 8 wk after the most recent dose of PCV13

3. If PPSV23 has been received but PCV13 has not, administer 1 dose of PCV13 at least 8 wk after the most recent dose of PPSV23

Heart, lung, diabetes, liver diseases in 6-18 year olds

• Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure)
• Chronic lung disease (including asthma if treated with high-dose oral corticosteroid therapy)
• Diabetes mellitus
• Alcoholism
• Chronic liver disease
• If the patient has not received PPSV23, administer 1 dose of PPSV23
• If PCV13 has been received previously, then PPSV23 should be administered at least 8 wk after any prior PCV13 dose

ACIP Guidelines, Revaccination

A single revaccination with PPSV23 should be administered 5 years after the first dose to children with:

Sickle cell disease or other hemoglobinopathies

Anatomic or functional asplenia

Congenital or acquired immunodeficiencies

HIV infection

Chronic renal failure

Nephrotic syndrome

Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease; generalized malignancy; solid organ transplantation; or multiple myeloma

Instructions

For IM or SC administration

Inject into the deltoid muscle or lateral mid-thigh

Pneumococcal Vaccine Polyvalent, Pnu-Imune 23 is a sterile liquid preparation intended for intramuscular or subcutaneous use. Pnu-Imune 23 consists of a mixture of purified capsular polysaccharides from the 23 most prevalent serotypes of Streptococcus pneumoniae (pneumococci) which are responsible for approximately 90% of serious pneumococcal disease in the United States (US). 1,2 The six serotypes (6B, 9V, 14, 19A, 19F, and 23F) that most frequently cause invasive drug-resistant pneumococcal infection in the U.S. are represented in the 23-valent vaccine. 3

Nomenclature

Pneumococcal Serotypes

Danish 1 2 3 4 5 6B 7F 8 9N 9V 10A 11A 12F 14 15B 17A 18C 19F 19A 20 22F 23F 33F

Each of the pneumococcal polysaccharide serotypes is produced separately to assure a high degree of purity. Cultures of pneumococcal serotypes are grown individually in a standard pneumococcal fermentation medium (modified Holt's medium supplemented with dextrose). Polysaccharide is separated from the bacterial cell and purified by a series of steps including ethanol fractionation. The vaccine is formulated to contain 25 µg of each of the 23 purified polysaccharide serotypes per 0.5 mL dose of vaccine. Each 0.5 mL dose contains approximately 50 µg of the preservative thimerosal (a mercury derivative) at a final concentration of 0.01%. The vaccine is a clear, colorless liquid formulation.

HYPERSENSITIVITY TO ANY COMPONENT OF THE VACCINE, INCLUDING THIMEROSAL, A MERCURY DERIVATIVE, IS A CONTRAINDICATION TO THE USE OF THE PRODUCT. THE OCCURRENCE OF ANY TYPE OF AN IMMEDIATE OR DELAYED HYPERSENSITIVITY REACTION OR THE OCCURRENCE OF NEUROLOGICAL SYMPTOMS OR SIGNS FOLLOWING ADMINISTRATION OF THIS PRODUCT IS A CONTRAINDICATION TO FURTHER USE.

Reimmunization is contraindicated for persons who had a severe reaction (eg, anaphylactic reactions or severe local arthus-type reactions) to the initial dose they received. 3

The decision to administer or delay immunization because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Although a severe or even a moderate febrile illness is sufficient reason to postpone immunizations, minor illnesses, such as a mild upper respiratory infection with or without low-grade fever, are not generally contraindications. 48

General

1. This product should not be used in children under 2 years of age.
2. PRIOR TO ADMINISTRATION OF ANY DOSE OF PNU-IMUNE 23, THE PARENT, GUARDIAN, OR ADULT PATIENT SHOULD BE ASKED ABOUT THE RECENT HEALTH STATUS, MEDICAL AND IMMUNIZATION HISTORY OF THE PATIENT TO BE IMMUNIZED TO DETERMINE THE EXISTENCE OF ANY CONTRAINDICATION TO IMMUNIZATION WITH PNEUMOCOCCAL VACCINE AND TO ALLOW AN ASSESSMENT OF RISKS AND BENEFITS (SEE CONTRAINDICATIONS AND WARNINGS ).
3. BEFORE ADMINISTRATION OF ANY BIOLOGICAL, THE HEALTH CARE PROFESSIONAL SHOULD TAKE ALL PRECAUTIONS KNOWN FOR THE PREVENTION OF ALLERGIC OR ANY OTHER ADVERSE REACTIONS. This should include a review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1,000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use.
4. A separate sterile syringe and needle or a sterile disposable unit should be used for each individual patient to prevent transmission of infectious agents from one person to another.
5. Do not inject intradermally, or into or near a blood vessel or nerve.
6. Health care professionals should administer this product with caution to patients with a possible history of latex sensitivity, since its packaging contains dry natural rubber.
7. Do not mix with other vaccines.

Information for Patients

PRIOR TO ADMINISTRATION OF THIS VACCINE, THE HEALTH CARE PROFESSIONAL SHOULD INFORM THE PARENT, GUARDIAN, OR ADULT PATIENT OF THE POTENTIAL BENEFITS AND RISKS TO THE PATIENT (SEE ADVERSE REACTIONS AND WARNINGS SECTIONS). PARENTS, GUARDIANS, OR THE ADULT PATIENT SHOULD BE INSTRUCTED TO REPORT ANY SUSPECTED ADVERSE REACTIONS TO THEIR HEALTH CARE PROFESSIONAL. THE HEALTH CARE PROFESSIONAL SHOULD PROVIDE VACCINE INFORMATION STATEMENTS PRIOR TO EACH IMMUNIZATION.

Drug Interactions

Individuals receiving therapy with immunosuppressive agents may not respond optimally to active immunization procedures. At least two weeks should elapse between immunization and subsequent initiation of chemotherapy or immunosuppressive therapy. 3

Immunization during chemotherapy or radiation therapy should be avoided (see WARNINGS ). 3

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Pnu-Imune 23 has not been evaluated for its carcinogenic or mutagenic potential or for its effects on fertility.

Pregnancy: Teratogenic Effects

Pregnancy Category C:   Animal reproduction studies have not been conducted with Pnu-Imune 23. It is also not known whether Pnu-Imune 23 can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Pnu-Imune 23 is not recommended for use in pregnant women.

Nursing Mothers

It is not known whether the vaccine antigens or antibodies resulting from stimulation by vaccine polysaccharides are excreted in human milk. Therefore, in the absence of data, caution should be exercised when Pnu-Imune 23 is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of 23-valent pneumococcal polysaccharide vaccine in pediatric populations under 2 years of age have not been established. Children under 2 years of age respond poorly or inconsistently to most capsular polysaccharide serotypes in the vaccine (see CLINICAL PHARMACOLOGY -- Immunogenicity , INDICATIONS AND USAGE , and DOSAGE AND ADMINISTRATION ). 3

Geriatric Use

Twenty-three-valent pneumococcal polysaccharide vaccine is recommended for persons >/=65 years of age, including previously unvaccinated persons and persons who have not received 23-valent pneumococcal polysaccharide vaccine within 5 years (and were <65 years of age at the time of immunization). 3

After immunization, antibody concentrations and responses to individual antigens may be lower in the elderly than those seen among healthy young adults. However, the levels of antibodies that correlate with pneumococcal disease protection have not been clearly defined. 3

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2. Butler JC, Breiman RF, Campbell JF, Lipman HB, Broome CV, Facklam RR. Pneumococcal polysaccharide vaccine efficacy: An evaluation of current recommendations. JAMA . 1993;270(15):1826-1831.
3. Centers for Disease Control and Prevention. Prevention of pneumococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997;46(8):1-24.
4. Mandell GL, Bennett, JE, Dolin R. Principles and Practices of Infectious Diseases . 4th ed. New York, N.Y. Churchill Livingstone Inc; 1995:1812-1813.
5. Robinson KA, Baughman W, Rothrock H, et al. Epidemiology of invasive Streptococcus pneumoniae infections in the United States, 1995-1998. Opportunities for prevention in the conjugate vaccine era. JAMA . 2001;285(13):1729-1735.
6. Centers for Disease Control and Prevention. Active bacterial core surveillance (ABCs) Report. Emerging infections program network: Streptococcus pneumoniae , 1999. 2000; Nov 15.
7. Davidson M, Parkinson AJ, Bulkow LR, Fitzgerald MA, Peters HV, Parks DJ. The epidemiology of invasive pneumococcal disease in Alaska, 1986-1990-Ethnic differences and opportunities for prevention. J. Infect Dis. 1994;170:368-376.
8. Cortese MM, Wolff M, Almeido-Hill J, Reid R, Ketcham J, Santosham M. High incidence rates of invasive pneumococcal disease in the White Mountain Apache population. Arch Intern Med. 1992; 152:2277-2282.
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20. Shapiro ED, Berg AT, Austrian R, et al. The protective efficacy of polyvalent pneumococcal polysaccharide vaccine. N Engl J Med. 1991;325(21):1453-1460.
21. Shapiro ED, Clemens, JD. A controlled evaluation of the protective efficacy of pneumococcal vaccine for patients at high risk of serious pneumococcal infections. Ann Intern Med. 1984;101:325-330.
22. Sims RV, Steinmann WC, McConville JH, King LR, Zwick WC, Schwartz JS. The clinical effectiveness of pneumococcal vaccine in the elderly. Ann Intern Med. 1988;108:653-657.
23. Farr BM, Johnston BL, Cobb DK, et al. Preventing pneumococcal bacteremia in patients at risk: Results of a matched case-control study. Arch Intern Med. 1995;155:2336-2340.
24. Forrester HL, Jahnigen DW, LaForce FM. Inefficacy of pneumococcal vaccine in a high- risk population. Am J Med. 1987;83:425-430.
25. Gaillat J, Zmirou D, Mallaret MR, et al. Essai clinique du vaccin antipneumococcique chez des personnes agées vivant en institution. Rev Epidémiol Santé Publique. 1985;33:437-444.
26. Simberkoff MS, Cross AP, Al-Ibrahim M, et al. Efficacy of pneumococcal vaccine in high-risk patients: Results of a Veterans Administration cooperative study. N Engl J Med. 1986;315(21):1318-1327.
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28. Douglas RM, Miles HB. Vaccination against Streptococcus pneumoniae in childhood: Lack of demonstrable benefit in young Australian children. J Infect Dis. 1984;149(6):861-869.
29. Data on file, Lederle Laboratories.
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31. Sullivan JL, Ochs HD, Schiffman G, et al. Immune response after splenectomy. Lancet. 1978;1:178-181.
32. Vernacchio L, Neufeld EJ, MacDonald K, et al. Combined schedule of 7-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal vaccine in children and young adults with sickle cell disease. J. Pediatr . 1998;133(2):275-278.
33. Carson PJ, Schut RL, Simpson ML, O'Brien J, Janoff EN. Antibody class and subclass responses to pneumococcal polysaccharides following immunization of human immunodeficiency virus-infected patients. J Infec Dis. 1995;172:340-345.
34. Rodriquez-Barradas MC, Groover JE, Lacke CE, et al. IgG antibody to pneumococcal capsular polysaccharide in human immunodeficiency virus-infected subjects: persistence of antibody in responders, revaccination in non-responders, and relationship of immunoglobulin allotype to response. J Infect Dis. 1996;173:1347-1353.
35. Mascart-Lemone F, Gerard M, Libin M, et al. Differential effect of human immunodeficiency virus infection on the IgA and IgG antibody responses to pneumococcal vaccine. J Infect Dis. 1995;172:1253-1260.
36. Mufson MA, Krause HE, Schiffman G. Long term persistence of antibodies following immunization with pneumococcal polysaccharide vaccine. Proc Soc Exp Bio Med. 1983;173:270-275.
37. Mufson MA, Krause HE, Schiffman G, Hughey DF. Pneumococcal antibody levels one decade after immunization of healthy adults. Am J Med Sci. 1987;293(5):279-284.
38. Giebink GS, Le CT, Schiffman G. Decline of serum antibody in splenectomized children after vaccination with pneumococcal capsular polysaccharides. J Pediatr. 1984;105:576-582.
39. Weintrub PS, Schiffman G, Addiego JE, et al. Long-term follow-up and booster immunization with polyvalent pneumococcal polysaccharide in patients with sickle cell anemia. J Pediatr. 1984;105(2):261-263.
40. Spika JS, Halsey NA, Le CT, et al. Decline of vaccine-induced antipneumococcal antibody in children with nephrotic syndrome. Am J Kidney Dis. 1986;VII(6):466-470.
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49. Siber GR, Gorham C, Martin P, Corkery JC, Schiffman G. Antibody response to pre-treatment immunization and post-treatment boosting with bacterial polysaccharide vaccines in patients with Hodgkin's disease. Ann Intern Med. 1986;104:467-475.
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Manufactured by:

LEDERLE LABORATORIES

Division American Cyanamid Company

Pearl River, NY 10965 USA

US GOVT. LICENSE NO. 17

Marketed by:

WYETH LEDERLE™
  V A C C I N E S

Wyeth-Ayerst Laboratories

Philadelphia, PA 19101 USA

CI 7576-1                            Issued May 10, 2002

PRODUCT PHOTO(S):