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).

Effectiveness Against Pneumococcal Disease

In a 14-year retrospective study

PNEUMOVAX 23 demonstrated reduction of disease in adults, including those with certain chronic conditions3,a-c

Effectiveness demonstrated against invasive pneumococcal infections caused by serotypes in the vaccine3,a-c

57% Overall in all populations (N=2,837)
DIABETES
MELLITUS
CORONARY
VASCULAR
DISEASE
CONGESTIVE
HEART
FAILURE
CHRONIC
PULMONARY
DISEASE
AGED ≥65 YEARS
(IMMUNOCOMPETENT)
84% 73% 69% 65% 75%
57% Overall in all populations (N=2,837)
DIABETES
MELLITUS
84%
CORONARY
VASCULAR
DISEASE
73%
CONGESTIVE
HEART FAILURE
69%
CHRONIC
PULMONARY
DISEASE
65%
AGED ≥65 YEARS
(IMMUNOCOMPETENT)
75%
  1. aEffectiveness was evaluated using the 14- or 23-capsular pneumococcal polysaccharide vaccine.
  1. bVaccine effectiveness could not be confirmed for certain groups of immunocompromised patients.
  1. cStudy Design: A US retrospective, indirect cohort study covering a 14-year period (1978–1992), in 54 hospitals and 26 states. Patients eligible for inclusion were ≥2 years of age with a known vaccination status/date, who were monitored for illness during this period and from whom pneumococcus was isolated from blood or cerebrospinal fluid (CSF). The median age of vaccinated patients was 57 years; the median age of unvaccinated patients was 50 years. Vaccine effectiveness was estimated by comparing the distribution of disease-causing pneumococcal serotypes in vaccinated (eg, received either the 14-valent or 23-valent pneumococcal polysaccharide vaccines) and unvaccinated persons. Vaccine effectiveness was also estimated for study participants with underlying medical conditions.3
Merck
ref3

Reference

  1. Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: an evaluation of current recommendations. JAMA. 1993;270(15):1826–1831.

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-00807 02/20