1. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012;61(40):816–819.
2. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822–825.
3. Centers for Disease Control and Prevention (CDC). Storage and handling. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:63–78.
4. Shea KM, Edelsberg J, Weycker D, et al. Rates of pneumococcal disease in adults with chronic medical conditions. Open Forum Infect Dis. 2014;1(1):1–9.
5. Boyanova L, Mitov I. Antibiotic resistance rates in causative agents of infections in diabetic patients: rising concerns. Expert Rev Anti Infect Ther. 2013;11(4):411–420.
6. Lung congestion. Encyclopedia Britannica. http://www.britannica.com/EBchecked/topic/351528/lung-congestion. Accessed April 4, 2016.
7. Ware LB, Matthay MA. Clinical practice. Acute pulmonary edema. N Engl J Med. 2005;353(26):2788–2796.
8. Mor A, Thomsen RW, Ulrichsen SP, et al. Chronic heart failure and risk of hospitalization with pneumonia: a population-based study. Eur J Intern Med. 2013;24(4):349–353.
9. Barnes PJ. Cellular and molecular mechanisms of chronic obstructive pulmonary disease. Clin Chest Med. 2014;35(1):71–86.
10. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39 (suppl 1):S1–S112.
11. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1131463-0001.
12. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes. J Am Coll Cardiol. 2014;64(24):e139–e228. doi:10.1016/j.jacc.2014.09.017.
13. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2016. http://www.goldcopd.org/global-strategy-diagnosis-management-prevention-copd-2016/. Accessed October 4, 2016.
14. Centers for Disease Control and Prevention (CDC). Intervals between PCV13 and PPSV23 vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2015;64(34):944–947. (Erratum Notice: CDC. MMWR Morb Mortal Wkly Rep. 2015;64(42):1204.)
15. Prevnar 13 [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2016.
16. Richter SS, Heilmann KP, Dohrn CL, et al. Pneumococcal serotypes before and after introduction of conjugate vaccines, United States, 1999–2011. Emerg Infect Dis. 2013;19(7):1074–1083.
17. Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010;59(34):1102−1106.
18. Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: an evaluation of current recommendations. JAMA. 1993;270(15):1826–1831.
19. Taitel M, Cohen E, Duncan I, et al. Pharmacists as providers: targeting pneumococcal vaccinations to high risk populations. Vaccine. 2011;29(45):8073–8076. doi:10.1016/j.vaccine.2011.08.051.
20. National Foundation for Infectious Diseases (NFID). Survey: disconnect in what doctors think they say about vaccines and what patients hear. http://www.nfid.org/newsroom/news-conferences/2010-news-conferences/2010-cdc-vaccination-rates-news-conference/2010-survey-backgrounder.pdf. Published November 2010. Accessed April 4, 2016.
21. Centers for Disease Control and Prevention (CDC). Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1997;46(RR-8):1–24.

Indication

PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) 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.

Select Safety Information for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

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

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

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.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

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 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), please read the accompanying Prescribing Information. The Patient Information also is available.

How Supplied/Storage and Handling

PNEUMOVAX 23 is supplied as follows:
Storage and Handling for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)
  • 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.
  • NDC 0006-4837-02 — a box of 1 single-dose, pre-filled Luer-Lok syringe with tip cap, color coded with a violet plunger rod and purple stripe on the syringe labels and carton.

Brands mentioned are the trademarks of their respective owners.

 
Storage and Handling for PNEUMOVAX 23
  • Store at 2°-8°C (36°-46°F).
  • All vaccine must be discarded after the expiration date.

The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex.

For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Center at 1-800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 AM – 7:00 PM ET.

 
General Tips for PNEUMOVAX 23
  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage; and call the Merck Vaccine Customer Center at 1-877-VAX-MERCK (1-877-829-6372), or call the CDC at 1-800-CDC-INFO (1-800-232-4636).
  • Rotate stock so that the earliest-dated vaccine is used first.3
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.3
  • Record refrigerator and freezer temperatures twice a day in a temperature log.3
  • 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.
  • Needles should be disposed of properly.3
  • All vaccines must be discarded after the expiration date; expired or damaged Vaccines for Children (VFC) vaccines must be returned to your State Immunization Program.3
  • For vaccines that are used as supplied, no reconstitution is necessary.
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Help Line at 1-800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 AM – 7:00 PM ET.
 

Indication

PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) 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.

Select Safety Information for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

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

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

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.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

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 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), please read the accompanying Prescribing Information. The Patient Information also is available.

CDC=Centers for Disease Control and Prevention.
VACC-1101056-0018 03/17
General Tips:
  • If you have questions about the condition of the vaccine at the time of delivery, you should immediately place vaccine in recommended storage; and call the Merck Vaccine Customer Center at 1-877-VAX-MERCK (1-877-829-6372), or call the CDC at 1-800-CDC-INFO (1-800-232-4636).
  • Rotate stock so that the earliest-dated vaccine is used first.6
  • Ensure that the refrigerator is plugged into an outlet in a protected area where it cannot be disconnected accidentally.6
  • Record refrigerator and freezer temperatures twice a day in a temperature log.6
  • 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.
  • Needles should be disposed of properly.6
  • All vaccines must be discarded after the expiration date; expired or damaged Vaccines for Children (VFC) vaccines must be returned to your State Immunization Program.6
  • For vaccines that are used as supplied, no reconstitution is necessary.
  • For general questions concerning the proper storage and handling of Merck vaccines, please contact the Merck Vaccine Customer Center at 1-800-MERCK-90 (1-800-637-2590), Monday through Friday, 8:00 AM to 7:00 PM ET.
About PNEUMOVAX 23

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.

Select Safety Information for PNEUMOVAX 23

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

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

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

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.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

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.

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), please read the accompanying Prescribing Information. The Patient Information also is available.