What are the indications, administration, and potential side effects of Prevenar 20 (pneumococcal conjugate vaccine) in adults 65 years or older or those with immunocompromising conditions or chronic heart or lung disease?

Prevenar 20 (PCV20): Comprehensive Clinical Overview

Indications

Prevenar 20 is indicated for all adults aged ≥65 years and for adults aged 19-64 years with specific chronic medical conditions or immunocompromising conditions. 1, 2

Age-Based Indications

• All adults ≥65 years should receive PCV20, regardless of underlying medical conditions 2
• Adults aged 19-64 years with qualifying conditions should receive PCV20 1, 2

Chronic Medical Conditions (Ages 19-64)

• Chronic heart disease, including congestive heart failure and cardiomyopathies 1, 2
• Chronic lung disease, including COPD, emphysema, and asthma 1, 2
• Chronic liver disease 1, 2
• Diabetes mellitus (type 1 or type 2) 1, 2
• Alcoholism 1
• Cigarette smoking (current smokers have 2.8-4.1 times increased risk for invasive pneumococcal disease) 1, 2
• Chronic renal failure 1

Immunocompromising Conditions (Ages 19-64)

• HIV infection 1, 2
• Congenital or acquired immunodeficiencies (B- or T-lymphocyte deficiency, complement deficiencies, phagocytic disorders) 1
• Iatrogenic immunosuppression (long-term systemic corticosteroids, radiation therapy) 1, 2
• Generalized malignancy, Hodgkin disease, leukemia, lymphoma, multiple myeloma 1, 2
• Solid organ transplant recipients 1, 2
• Congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies 1, 2
• Nephrotic syndrome 1
• Cerebrospinal fluid (CSF) leak 1
• Cochlear implant 1

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Administration Guidelines

Administer PCV20 as a single 0.5 mL intramuscular injection, with specific timing based on prior pneumococcal vaccination history. 2, 3

For Pneumococcal Vaccine-Naïve Adults

• Administer one dose of PCV20 alone 1, 2
• No additional pneumococcal vaccines are needed after PCV20 2

For Adults Previously Vaccinated with PPSV23 Only

• Administer one dose of PCV20 ≥1 year after the last PPSV23 dose 1, 2
• This completes the pneumococcal vaccination series 2

For Adults Previously Vaccinated with PCV13 Only

• Administer one dose of PCV20 ≥1 year after the PCV13 dose 1, 2
• This provides broader serotype coverage and completes the series 2

For Adults Who Received Both PCV13 and PPSV23

• For adults aged 19-64 years with immunocompromising conditions: Administer PCV20 ≥5 years after the last pneumococcal vaccine dose 1, 2
• For adults aged ≥65 years who completed the series with both PCV13 and PPSV23: Use shared clinical decision-making regarding PCV20 administration ≥5 years after the last dose 1, 2

Special Timing Considerations

• For immunocompromised adults, CSF leak, or cochlear implant: The minimum interval between PCV15 and PPSV23 can be shortened to ≥8 weeks (though this applies to the PCV15/PPSV23 series, not PCV20) 1
• For hematopoietic stem cell transplant (HSCT) recipients: Use a 4-dose series of PCV20 starting 3-6 months after HSCT, with the first 3 doses given 4 weeks apart, and the fourth dose ≥6 months after the third dose or ≥12 months after HSCT, whichever is later 2

Route and Site

• Intramuscular injection (deltoid muscle preferred) 3
• Single 0.5 mL dose 3

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Safety Profile and Adverse Effects

PCV20 is well-tolerated with predominantly mild-to-moderate local and systemic reactions that resolve within days. 1, 3, 4

Local Reactions (Within 10 Days)

Most common local reactions occur at the injection site and are generally mild. 3

In Pneumococcal Vaccine-Naïve Adults Aged 18-49 Years:

• Pain at injection site: 81.2% (any severity), with 42.7% mild, 38.2% moderate, 0.3% severe 3
• Swelling >2.0 cm: 11.6% (any severity), with 7.2% mild, 4.5% moderate, 0% severe 3
• Redness >2.0 cm: 9.0% (any severity), with 3.0% mild, 5.4% moderate, 0.6% severe 3

In Adults Aged ≥60 Years (Vaccine-Naïve):

• Pain at injection site: 55.4% (any severity), with 45.3% mild, 9.9% moderate, 0.2% severe 3
• Swelling >2.0 cm: 7.5% (any severity) 3
• Redness >2.0 cm: 7.3% (any severity) 3

In Adults ≥65 Years with Prior Pneumococcal Vaccination:

• Pain at injection site: 50.2%-61.2% depending on prior vaccination history 3
• Swelling >2.0 cm: 4.0%-14.3% depending on prior vaccination history 3
• Redness >2.0 cm: 4.8%-12.7% depending on prior vaccination history 3

Systemic Reactions (Within 7 Days)

Systemic reactions are common but predominantly mild-to-moderate and self-limited. 3

In Pneumococcal Vaccine-Naïve Adults Aged 18-49 Years:

• Muscle pain: 66.6% (any severity), with 36.4% mild, 29.0% moderate, 1.2% severe 3
• Fatigue: 42.7% (any severity), with 18.8% mild, 22.1% moderate, 1.8% severe 3
• Headache: 38.8% (any severity), with 21.5% mild, 14.6% moderate, 2.7% severe 3
• Joint pain: 13.4% (any severity), with 6.3% mild, 7.2% moderate, 0% severe 3
• Fever ≥38.0°C: 1.2% 3

In Adults Aged ≥60 Years (Vaccine-Naïve):

• Muscle pain: 39.1% (any severity), with 28.9% mild, 9.8% moderate, 0.4% severe 3
• Fatigue: 30.2% (any severity), with 16.1% mild, 12.8% moderate, 1.2% severe 3
• Headache: 21.5% (any severity), with 15.5% mild, 5.4% moderate, 0.7% severe 3
• Fever ≥38.0°C: 0.9% 3

In Adults ≥65 Years with Prior Pneumococcal Vaccination:

• Muscle pain: 32.0%-46.0% depending on prior vaccination history 3
• Fatigue: 22.3%-33.3% depending on prior vaccination history 3
• Headache: 13.5%-21.4% depending on prior vaccination history 3
• Fever ≥38.0°C: 0%-1.6% depending on prior vaccination history 3

Serious Adverse Events

Serious adverse events are rare and show no causal relationship to PCV20. 1, 3

• Within 1 month after vaccination: 0.4% of participants (19 of 4,552) 1
• Within 6 months after vaccination: 1.5% of participants (67 of 4,552) 3
• No notable patterns or imbalances between PCV20 and control vaccine groups for specific categories of serious adverse events 1

Concomitant Administration with Influenza Vaccine

PCV20 can be safely administered concomitantly with influenza vaccine, though systemic reactions may be slightly higher. 3

• Rates of local reactions at the PCV20 injection site were similar whether given concomitantly or separately 3
• Systemic reactions were numerically higher with concomitant administration, but fever remained uncommon (<1.5%) and other reactions were primarily mild-to-moderate 3

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Important Clinical Considerations

Vaccine Effectiveness and Immunogenicity

PCV20 demonstrates robust immune responses across all age groups and prior vaccination histories. 1, 4

• Phase 3 trials showed PCV20 is safe and immunogenic in adults ≥18 years, including those previously vaccinated with PCV13 or PPSV23 1, 4
• Opsonophagocytic antibody responses to all 20 vaccine serotypes were observed 1 month after vaccination 4
• Immune responses were maintained regardless of prior pneumococcal vaccination history 4

Rationale for PCV20 Over Sequential PCV13/PPSV23

PCV20 simplifies the vaccination schedule and provides immunologic advantages over polysaccharide vaccines. 2

• Conjugate vaccines like PCV20 induce T-cell dependent responses and immunologic memory, unlike PPSV23 2
• Single-dose PCV20 eliminates the need for patients to return for a second dose 2
• After PCV20 administration, no additional pneumococcal vaccines are needed in most scenarios 2

Common Pitfalls to Avoid

Do not administer PCV20 before the minimum required interval after prior pneumococcal vaccination. 2

• The 1-year minimum interval after PCV13 or PPSV23 must be observed for optimal immune response 2
• The 5-year interval applies only when both PCV13 and PPSV23 were previously given 2
• Do not add PPSV23 after PCV20 – once PCV20 is administered, the pneumococcal vaccination series is complete 2

Shared Clinical Decision-Making Scenarios

For adults ≥65 years who completed both PCV13 and PPSV23, consider individual risk factors when deciding on PCV20. 1, 2

Factors favoring PCV20 administration include:

• Immunocompromising conditions (HIV, transplant, malignancy, chronic renal failure, nephrotic syndrome, iatrogenic immunosuppression) 1
• Multiple chronic medical conditions (>1 condition including alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes) 1
• CSF leak or cochlear implant 1
• Time elapsed ≥5 years since last pneumococcal vaccination 1
• Higher residual disease burden in these groups despite prior vaccination 1

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Summary Algorithm for PCV20 Administration

1. Verify vaccination history and calculate time since last pneumococcal vaccine 2
2. If pneumococcal vaccine-naïve: Give PCV20 now (series complete) 2
3. If PPSV23 only: Give PCV20 if ≥1 year since PPSV23 (series complete) 2
4. If PCV13 only: Give PCV20 if ≥1 year since PCV13 (series complete) 2
5. If both PCV13 and PPSV23 (age 19-64 with immunocompromising conditions): Give PCV20 if ≥5 years since last dose (series complete) 2
6. If both PCV13 and PPSV23 (age ≥65): Use shared decision-making; if given, administer ≥5 years after last dose 1, 2
7. Document that pneumococcal vaccination series is complete after PCV20 2