What are the indications, dosing schedule, and contraindications for the 23‑valent pneumococcal polysaccharide vaccine (PPSV23) in adults?

PPSV23 (Pneumovax 23): Indications, Dosing, and Contraindications

Primary Indication

PPSV23 is FDA-approved for active immunization against pneumococcal disease in adults ≥50 years and persons ≥2 years at increased risk, but current ACIP guidelines (2023) position it as a second-line option following conjugate vaccines (PCV20, PCV15) rather than as initial therapy. 1, 2

Current Role in Adult Vaccination Strategy

Preferred Approach (2023 ACIP Guidelines)

• Adults ≥65 years should receive PCV20 as a single dose (preferred option), which completes the pneumococcal series without requiring PPSV23. 3
• Alternatively, PCV15 followed by PPSV23 ≥1 year later is acceptable, though less preferred due to the two-dose requirement. 3
• PPSV23 is now primarily used as a follow-up vaccine after PCV15, not as initial therapy. 2

When PPSV23 Is Currently Used

PPSV23 administration occurs in three specific scenarios:

1. Following PCV15 in immunocompetent adults: Give PPSV23 ≥1 year after PCV15 2, 3
2. Following PCV15 in immunocompromised adults: Give PPSV23 ≥8 weeks after PCV15 3, 4
3. Revaccination in select high-risk groups: Second PPSV23 dose ≥5 years after first dose (only for specific immunocompromising conditions if first dose given before age 65) 3, 1

Dosing and Administration

Standard Dose

• 0.5 mL administered either intramuscularly (preferred) or subcutaneously 2, 1
• Intramuscular route causes fewer local adverse reactions (7.1% vs 18.9% subcutaneous) with equivalent immunogenicity 2
• Administer into deltoid muscle or lateral mid-thigh 1

Timing Intervals (Critical for Optimal Response)

For immunocompetent adults:

• ≥1 year after PCV13 or PCV15 2, 3
• ≥1 year after prior PPSV23 (if transitioning to add conjugate vaccine) 3

For immunocompromised adults (including HIV, malignancy, transplant, chronic renal failure, asplenia, immunosuppressive therapy):

• ≥8 weeks after PCV13 or PCV15 3, 4
• This shorter interval reflects greater urgency for protection in high-risk patients 3

Maximum Lifetime Doses

• Immunocompetent adults: Maximum 1-2 doses total 3
• Immunocompromised adults: Maximum 2-3 doses total 3
• No additional PPSV23 doses after the dose given at age ≥65 years 3, 1

Specific Indications by Risk Category

Age-Based Indication

• Adults ≥50 years (FDA-approved) 1
• Adults ≥65 years (when used after PCV15) 2, 3

Chronic Medical Conditions (Ages 19-64 Years)

• Chronic heart disease (including congestive heart failure, cardiomyopathies) 5
• Chronic lung disease (including COPD, emphysema, asthma) 5
• Chronic liver disease (including cirrhosis) 5
• Diabetes mellitus 5
• Alcoholism 5
• Current cigarette smoking (2.8-4.1× increased risk for invasive pneumococcal disease) 5

Immunocompromising Conditions (Ages ≥2 Years)

• Congenital or acquired immunodeficiencies 3, 5
• HIV infection 3, 5
• Chronic renal failure or nephrotic syndrome 3, 5
• Functional or anatomic asplenia (including sickle cell disease) 3, 5
• Malignancies (leukemia, lymphoma, Hodgkin disease, multiple myeloma, generalized malignancy) 5, 4
• Iatrogenic immunosuppression (including cancer chemotherapy, systemic corticosteroids) 5, 4
• Solid organ transplant recipients 5

Anatomic/Mechanical Risk Factors

• Cerebrospinal fluid leak 3
• Cochlear implants 3

Contraindications

Absolute Contraindication

• History of anaphylactic/anaphylactoid or severe allergic reaction to any vaccine component (including 0.25% phenol preservative) 1

Precautions (Defer Vaccination)

• Moderate or severe acute illness (defer until recovery) 1
• Severely compromised cardiovascular or pulmonary function where systemic reaction would pose significant risk 1

Vaccine Efficacy Data

Against Invasive Pneumococcal Disease (IPD)

• 63% efficacy against all-serotype IPD in randomized controlled trials 2
• 60% effectiveness against vaccine-type IPD in immunocompetent adults 2
• 45% effectiveness against vaccine-type IPD in observational studies (includes immunocompromised patients) 2

Against Pneumococcal Pneumonia

• 64% efficacy in low-bias RCTs 2
• Variable effectiveness (0-50%) in observational studies due to heterogeneous case definitions and populations 2
• 18% effectiveness against vaccine-type pneumococcal pneumonia (not statistically significant) 2

Important Clinical Caveats

Diminished Immune Response

• Immunocompromised patients may have reduced antibody response to PPSV23 1
• Prior PPSV23 administration diminishes response to subsequent PCV13 administration (hyporesponsiveness phenomenon) 6
• This is why current guidelines prioritize conjugate vaccines first 2, 3

Does Not Replace Antibiotic Prophylaxis

• Continue penicillin (or other antibiotic) prophylaxis in patients who require it; vaccination does not eliminate this need 1

Limited Efficacy in Specific Scenarios

• May not prevent pneumococcal meningitis in patients with chronic CSF leak 1
• Protection may wane after 5 years, particularly in adults ≥75 years and those with certain underlying conditions 7

Revaccination Restrictions

• Routine revaccination of immunocompetent adults is NOT recommended 1
• Only specific high-risk immunocompromised patients receive second PPSV23 dose ≥5 years after first dose (and only if first dose given before age 65) 3, 1
• Avoid unnecessary revaccination due to uncertainty regarding clinical benefit and potential safety concerns 3

Common Adverse Reactions

Most frequent reactions (>10% in clinical trials):

• Injection-site pain/soreness/tenderness (60.0%) 1
• Injection-site swelling/induration (20.3%) 1
• Headache (17.6%) 1
• Injection-site erythema (16.4%) 1
• Asthenia/fatigue (13.2%) 1
• Myalgia (11.9%) 1

Practical Implementation Algorithm

For adults ≥65 years, never previously vaccinated:

1. Give PCV20 as single dose (series complete) 3
2. Alternative: Give PCV15 now, then PPSV23 ≥1 year later 3

For adults 19-64 years with chronic conditions:

1. Give PCV20 as single dose (series complete) 3, 5
2. Alternative: Give PCV15 now, then PPSV23 ≥1 year later 3

For immunocompromised adults 19-64 years:

1. Give PCV20 as single dose (series complete) 3
2. Alternative: Give PCV15 now, then PPSV23 ≥8 weeks later, then second PPSV23 ≥5 years after first PPSV23 3

For adults who previously received only PPSV23:

1. Give PCV20 ≥1 year after last PPSV23 dose (series complete) 3

For adults who previously received PCV15 only:

1. Give PPSV23 ≥1 year later (immunocompetent) or ≥8 weeks later (immunocompromised) 3