PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated in controlled trials in South Africa, France and in case-control studies.

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

If it is known that a person has not received any pneumococcal vaccine or if earlier pneumococcal vaccination status is unknown, then persons in the categories listed below should be administered pneumococcal vaccine; however, if a person has received a primary dose of pneumococcal vaccine, before administering an additional dose of vaccine, please refer to the Revaccination section.

Vaccination with PNEUMOVAX 23 is recommended for selected individuals as follows:

Immunocompetent persons:

• routine vaccination for persons 50 years of age or older ^†
• persons aged ³2 years with chronic cardiovascular disease (including congestive heart failure and cardiomyopathies), chronic pulmonary disease (including chronic obstructive pulmonary disease and emphysema), or diabetes mellitus¹
• persons aged ³2 years with alcoholism, chronic liver disease (including cirrhosis) or cerebrospinal fluid leaks¹
• persons aged ³2 years with functional or anatomic asplenia (including sickle cell disease and splenectomy) ¹
• persons aged ³2 years living in special environments or social settings (including Alaskan Natives and certain American Indian populations) ¹

Immunocompromised persons:

• persons aged ³2 years, including those with HIV infection, leukemia, lymphoma, Hodgkin†s disease, multiple myeloma, generalized malignancy, chronic renal failure or nephrotic syndrome; those receiving immunosuppressive chemotherapy (including corticosteroids); and those who have received an organ or bone marrow transplant. ¹

Timing of Vaccination

Pneumococcal vaccine should be given at least two weeks before elective splenectomy, if possible.

For planning cancer chemotherapy or other immunosuppressive therapy (e.g., for patients with Hodgkin†s disease or those who undergo organ or bone marrow transplantation), pneumococcal vaccination should be administered at least two weeks prior to the initiation of immunosuppressive therapy. Vaccination during chemotherapy or radiation therapy should be avoided. Based on literature reports, pneumococcal vaccine may be given as early as several months following completion of chemotherapy or radiation therapy for neoplastic disease.34,36 In Hodgkin†s disease, immune response to vaccination may be impaired for two years or longer after intensive chemotherapy (with or without radiation). During the two years following the completion of chemotherapy or other immunosuppressive therapy, antibody responses improve in some patients as the interval between the end of treatment and pneumococcal vaccination increases. ³⁴

Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Use With Other Vaccines

The ACIP states that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine. ¹ In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations. ³¹

Revaccination

Early studies have indicated that local reactions (i. e., arthus-type reactions) among adults receiving the second dose of 14-valent vaccine within 2 years after the first dose are more severe than those occurring after initial vaccination. However, subsequent studies have suggested that revaccination after intervals of ³4 years is not associated with an increased incidence of adverse side effects.¹

Routine revaccination of immunocompetent persons previously vaccinated with 23-valent polysaccharide vaccine is not recommended.¹ However, revaccination once is recommended for persons ³2 years of age who are at highest risk of serious pneumococcal infection and those likely to have a rapid decline in pneumococcal antibody levels, provided that at least five years have passed since receipt of a first dose of pneumococcal vaccine. ¹

The highest risk group includes persons with functional or anatomic asplenia (e.g., sickle cell disease or splenectomy), HIV infection, leukemia, lymphoma, Hodgkin†s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, or other conditions associated with immunosuppression (e.g., organ or bone marrow transplantation), and those receiving immunosuppressive chemotherapy (including long-term systemic corticosteroids).¹

For children £10 years of age at revaccination and at highest risk of severe pneumococcal infection (e.g., children with functional or anatomic asplenia, including sickle cell disease or splenectomy or conditions associated with rapid antibody decline after initial vaccination including nephrotic syndrome, renal failure or renal transplantation), the ACIP recommends that revaccination may be considered three years after the previous dose.¹

If prior vaccination status is unknown for patients in the high risk group, patients should be given pneumococcal vaccine.¹

All persons ³65 years of age who have not received vaccine within 5 years (and were < 65 years of age at the time of vaccination) should receive another dose of vaccine.¹

Because data are insufficient concerning the safety of pneumococcal vaccine when administered three or more times, revaccination following a second dose is not routinely recommended.¹

Do not inject intravenously or intradermally.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PNEUMOVAX 23 is a clear, colorless solution. The vaccine is used directly as supplied. No dilution or reconstitution is necessary. Phenol 0.25% has been added as a preservative.

It is important to 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.

Administer a single 0.5 mL dose of PNEUMOVAX 23 subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh), with appropriate precautions to avoid intravascular administration.

Store unopened and opened vials at 2-8° C( 36-46° F). The vaccine is used directly as supplied. No dilution or reconstitution is necessary. Phenol 0.25% has been added as a preservative. All vaccine must be discarded after the expiration date.

Use With Other Vaccines

The ACIP states that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine.¹ In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations. ³

No. 4739 † PNEUMOVAX 23 is supplied as one 5-dose vial of liquid vaccine, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4739-00.

No. 4739 † PNEUMOVAX 23 is supplied as one 5-dose vial of liquid vaccine, in a box of 10 five-dose vials, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4739-50.

No. 4943 † PNEUMOVAX 23 is supplied as a single-dose vial of liquid vaccine, in a box of 10 singledose vials, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4943-00.

REFERENCES

1. Recommendation of the Advisory Committee on Immunization Practices † Prevention of Pneumococcal Disease, Morbidity and Mortality Weekly Report, 46(RR-8): 1-25, April 4, 1997.

2. Robbins, J. B.; Lee, C. J.; Schiffman, G.; Austrian, R.; Henrichsen, J.; Mγ¤kelγ¤, RH.; Broome, C. V.; Facklam, R. R.; Tiesjema, RH.; Rastogi, S. C.: Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups, J. Infect. Dis. 148: 1136-1159, 1983.

3. WHO: Vital statistics and causes of death, World Health Statistics Annual, 1, 1976.

4. Austrian, A.; Gold, J.: Pneumococcal bacteremia with especial reference to bacteremic pneumococcal pneumonia, Ann. Intern. Med. 60: 759-776, 1964.

5. Austrian, R.: Random gleanings from a life with the pneumococcus, J. Infect. Dis. 131: 474-484, 1975.

6. Austrian, R.: Vaccines of pneumococcal capsular polysaccharides and the prevention of pneumococcal pneumonia ; †The role of immunological factors in infectious, allergic and autoimmune processes†, R. F. Beers, Jr. and E. G. Bassett (eds.), New York, Raven Press: 79-89, 1976.

7. Mufson, M. A.; Kruss, D. M.; Wasil, R. E.; Metzger, WI.: Capsular types and outcome of bacteremic pneumococcal disease in the antibiotic era, Arch. Intern. Med. 134: 505-510, 1974.

8. Mufson, M. A.: Pneumococcal infections, J. A. M. A. 246 (17): 1942-1948, 1981.

9. Barrett-Connor, E.: Bacterial infection and sickle cell anemia: an analysis of 250 infections in 166 patients and a review of the literature, Medicine 50: 97-112, 1971.

10. Unpublished data; files of Merck Research Laboratories.

11. Borgono, J. M.; McLean, A. A.; Vella, RR; Woodhour, A. F.; Canepa, I.; Davidson, W. L.; Hilleman, M. R.: Vaccination and revaccination with polyvalent pneumococcal polysaccharide vaccines in adults and infants (40010), Proc. Soc. Exper. Biol. & Med. 157: 148- 154, 1978.

12. Hilleman, M. R.; McLean, A. A.; Vella, RR; Weibel, R. E.; Woodhour, A. F.: Polyvalent pneumococcal polysaccharide vaccines, Bull. World Health Organ. 56: 371-375, 1978.

13. Smit, P.; Oberholzer, D.; Hayden-Smith, S.; Koornhof, H. J.; HilIeman, M. R.: Protective efficacy of pneumococcal polysaccharide vaccines, J. A. M. A. 238: 2613-2616, 1977.

14. Weibel, R. E.; Vella, RR; McLean, A. A.; Woodhour, A. F.; Hilleman, M. R.: Studies in human subjects of polyvalent pneumococcal vaccines (39894), Proc. Soc. Exper. Biol. & Med. 156: 144- 150, 1977.

15. 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.

16. 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.

17. Simberkoff, M. S.; Cross, A. R; Al-Ibrahim, M.: Efficacy of pneumococcal vaccine in high risk patients: results of a Veterans Administration cooperative study, New Engl. J. Med. 315: 1318- 27, 1986.

18. Broome, C. V.: Efficacy of pneumococcal polysaccharide vaccines, Rev. Infect. Dis. 3( suppl): S82- S96, 1981.

19. Spika, J. S.; Fedson, D. S.; Facklam, R. R.: Pneumococcal vaccination-controversies and opportunities, Infect. Dis. Clin. North Am. 4: 11-27, 1990.

20. Fine, M. J.; Smith, M. A.; Carson, C. A.; Meffe, F.; Sankey, S. S.; Weissfeld, L. A.; Detsky, A. S.; Kapoor, W. N.: Efficacy of pneumococcal vaccination in adults: a meta-analysis of randomized controlled trials, Arch. Intern. Med. 154: 2666- 77, 1994.

21. Fedson, D. S.; Shapiro, E. D.; LaForce, F. M.; Mufson, M. A.; Musher, D. M.; Spika, J. S.; Breiman, R. F.: Pneumococcal vaccine after 15 years of use: another view, Arch. Intern. Med. 154: 2531- 35, 1994.

22. Butler, J. C.; Brelman, R. F.; Campbell, J. F.; Lipman, H. B.; Broome, C. V.; Facklam, A .R.: Pneumococcal polysaccharide vaccine efficacy. An evaluation of current recommendations, J. A. M. A. 270: 1826- 31, 1993.

23. Shapiro, E. D.; Berg, A. T.; Austrian, R.; Schroeder, D.; Parcells, V.; Margolis, A.; Adair, R. K.; Clemens, J. D.: The protective efficacy of polyvalent pneumococcal polysaccharide vaccine, New Engl. J. Med. 325: 1453- 60, 1991.

24. Farr, B. M.; Johnston, B. L.; Cobb, O. K.; Fisch, M. J.; Germanson T. R; Adal, K. A.; Anglim, A. M.: Preventing pneumococcal bacteremia in patients at risk. Results of a matched case-control study, Arch. Intern. Med. 155: 2336- 2340, 1995.

25. Shapiro, E. D.; Clemens, J. D.: A controlled evaluation of the protective efficacy of pneumococcal vaccine for patients at high risk of serious pneumococcal infections, Ann. Intern. Med. 101: 325- 30, 1984.

26. Sims, R. V.; Steinmann, W. C.; McConviue, J. H.; King, LA.; Zwick, W. C.; Schwartz, J. S.: The clinical effectiveness of pneumococcal vaccine in the elderly, Ann. Intern. Med 108: 653- 7, 1988.

27. Forrester, H. L; Jahnigen, D. W.; LaForce, F. M.: Inefficacy of pneumococcal vaccine in a high-risk population, Am. J. Med. 83: 425-30, 1987.

28. 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, New Engl. J. Med. 297: 897-900, 1977.

29. Musher, D. M.; Groover, J. E.; Rowland, J. M.; Watson, D. A.; Struewing, J. B.; Baughn, R. E.; Mufson, M. A.: Antibody to capsular polysaccharides of Streptococcus pneumoniae: prevalence, persistence, and response to revaccination, Clinical Infect. Dis. 17: 66-73, 1993.

30. Konradsen, H. B.: Quantity and avidity of pneumococcal antibodies before and up to five years after pneumococcal vaccination of elderly persons, Clinical Infect. Dis. 21: 616-20, 1995.

31. Carlson, A. J.; Davidson, W. L.; McLean, A. A.; Vella, PR; Weibel, R. E.; Woodhour, A. F.; Hilleman, M. R.: Pneumococcal vaccine dose, revaccination, and coadministration with influenza vaccine (40596), Proc. Soc. Exp. Biol. & Med. 161: 558-563, 1979.

32. Vaccine Adverse Event Reporting System-United States, Morbidity and Mortality Weekly Report 39( 41): 730-33, October 19, 1990.

33. Kelton, J. G.: Vaccination-associated relapse of immune thrombocytopenia, J. Am. Med. Assoc. 245( 4): 369-371, 1981.

34. Siber, G. R.; Weitzman, S. A.; Aisenberg, A. C.: Antibody response of patients with Hodgkin†s disease to protein and polysaccharide antigens, Rev. Infect. Dis. 3(Suppl): S144-S159, March-April 1981.

35. Siber, G. R.; Gorham, C.; Martin, P.; Corkery, J. C.; Schiffman, G.: Antibody response to pretreatment immunization and post-treatment boosting with bacterial polysaccharide vaccines in patients with Hodgkin†s disease, Ann Intern Med. 104: 467-475, 1986.

Bookmark this page: