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).

CDC Pneumococcal Vaccination Recommendations for Adults Aged ≥65 Years1

For all appropriate adults aged ≥65 years:

Routinely administer a single dose of PNEUMOVAX 23

Video: Learn About the Updated CDC Recommendations On How to Help Protect Patients Aged 65+ From Pneumococcal Disease

Video

Learn about the updated CDC recommendations on how to help protect patients ages 65+ from pneumococcal disease. Presented by Dr. Javeed Siddiqui, an infectious disease specialist.

CDC recommendations for immunocompetent adults aged ≥65 years:
Sequential administration and intervals, when applicable1,a,b

For pneumococcal vaccine-naïve persons aged ≥65 years

Sequential Administration, if applicable, of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) for Pneumococcal Vaccine-Naïve Persons Aged ≥65 Years 

For all appropriate persons who only received a dose of Prevnar 13 at or after age 65 based on prior (2014) CDC recommendations, administer a dose of PNEUMOVAX 23 at least one year later.

For persons who previously received PNEUMOVAX 23 before age 65 years who are now aged ≥65 years

Sequential Administration, if applicable, of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) for Persons Who Previously Received PNEUMOVAX 23 Before Age 65 Who Are Now Aged ≥65 years  

bPNEUMOVAX 23 and Prevnar 13 should not be coadministered.

CDC=Centers for Disease Control and Prevention, CSF=cerebrospinal fluid.

Important Considerations

  • There are limited data on the sequential administration of PNEUMOVAX 23 with other vaccines, including Prevnar 13.
  • An immunogenicity study described in the Prescribing Information for Prevnar 13 evaluated the sequential administration with PNEUMOVAX 23 in adults aged 60–64 years5:
    • Diminished immune response with one dose of PNEUMOVAX 23 followed by a dose of Prevnar 13 one year later vs Prevnar 13 alone
    • Noninferior immune response with one dose of Prevnar 13 followed by a dose of PNEUMOVAX 23 one year later vs PNEUMOVAX 23 alone
  • The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
  • Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended.
  • For subjects aged ≥65 years in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination with PNEUMOVAX 23 than following initial vaccination with PNEUMOVAX 23.

Prevnar 13 is a registered trademark of Wyeth LLC.

Pneumococcal Vaccination Opportunities

According to a CDC Retrospective Analysis of Eligible Immunocompetent Patients 65 Years and Older, 57% Have Not Received PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), Which is Recommended by the CDC for All Appropriate Adults in This Group

Not actual patients

According to a CDC retrospective analysis of patients aged ≥65 years

57% have not received PNEUMOVAX 23, which is recommended by the CDC for all appropriate adults in this group1,6,7

CDC=Centers for Disease Control and Prevention.

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Shared clinical decision-making

Shared clinical decision-making considerations may include the individual patient’s risk of exposure to Prevnar 13 serotypes and the risk of pneumococcal disease for that person as a result of underlying medical conditions.1

Reference: 1. 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: updated recommendations of the Advisory Committee on Immunization Practices. MMWR. 2019;68(46):1069–1075.

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Excluding those with CSF leak or
cochlear implant

For immunocompetent adult patients aged ≥65 years with CSF leak or cochlear implant, the CDC recommends a routine dose of Prevnar 13 (if not previously received) followed at least 8 weeks later by a routine dose of PNEUMOVAX 23.1,a

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic CSF leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

Reference: 1. 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: updated recommendations of the Advisory Committee on Immunization Practices. MMWR. 2019;68(46):1069–1075.

aPNEUMOVAX 23 and Prevnar 13 should not be coadministered.

CDC=Centers for Disease Control and Prevention,

CSF=cerebrospinal fluid.

ref1

Reference

  1. 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: updated recommendations of the Advisory Committee on Immunization Practices. MMWR. 2019;68(46):1069–1075.
ref4

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: surveillance and reporting. cdc.gov/pneumococcal/surveillance.html. Updated August 1, 2018. Accessed November 12, 2019.
ref5

Reference

  1. Prevnar 13 [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2019.
ref6

Reference

  1. Centers for Disease Control and Prevention (CDC). Adult Vax View. Pneumococcal vaccination among U.S. Medicare beneficiaries aged ≥65 years, 2009-2017. https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/pcv13-medicarebeneficiaries.html. Updated September 4, 2018. Accessed January 24, 2020.
ref7

Reference

  1. Centers for Disease Control and Prevention (CDC). Pneumococcal vaccination among Medicare beneficiaries occurring after the Advisory Committee on Immunization Practices recommendation for routine use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults aged ≥ 65 years. MMWR. 2017;66(27):728–733.

Indication for PNEUMOVAX 23

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.

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.

Do not administer PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) 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.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

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, please read the accompanying Prescribing Information. The Patient Information also is available.

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.


US-PNX-01116 08/20