What are the indications for Prevnar 20 (Pneumococcal conjugate vaccine)?

Prevnar 20 (PCV20) Indications

Prevnar 20 is indicated for active immunization to prevent invasive pneumococcal disease caused by 20 serotypes of Streptococcus pneumoniae in individuals aged 6 weeks and older, prevention of otitis media in children 6 weeks through 5 years, and prevention of pneumonia in adults aged ≥18 years. 1

FDA-Approved Indications

Prevention of Invasive Pneumococcal Disease

• PCV20 is approved for active immunization to prevent invasive disease caused by S. pneumoniae serotypes 1,3,4,5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals aged ≥6 weeks. 1

Prevention of Otitis Media

• PCV20 is indicated for active immunization to prevent otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children 6 weeks through 5 years of age. 1

Prevention of Pneumonia

• PCV20 is indicated for active immunization to prevent pneumonia caused by S. pneumoniae serotypes 1,3,4,5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals aged ≥18 years. 1
• The indication for prevention of pneumonia caused by serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in adults ≥18 years was approved under accelerated approval based on immune responses measured by opsonophagocytic activity assay. 1

ACIP-Recommended Populations for PCV20

Age-Based Recommendations

• All adults aged ≥50 years who are PCV-naïve should receive a single dose of PCV20. 2
• The ACIP expanded age-based recommendations in October 2024 to include adults aged 50-64 years, lowering the threshold from the previous ≥65 years recommendation. 2

Risk-Based Recommendations for Adults Aged 19-49 Years

• Adults aged 19-49 years with immunocompromising conditions (HIV infection, congenital or acquired immunodeficiencies, iatrogenic immunosuppression, generalized malignancy, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplant) should receive PCV20. 3, 4
• Adults aged 19-49 years with chronic medical conditions including chronic heart disease, chronic lung disease, chronic liver disease, diabetes mellitus, and alcoholism should receive PCV20. 3, 4
• Current cigarette smokers aged 19-49 years should receive PCV20, as smoking confers 2.8-4.1 times increased risk for invasive pneumococcal disease. 3, 4
• Adults with sickle cell disease or other hemoglobinopathies should receive PCV20. 3
• Adults with cerebrospinal fluid leak or cochlear implants should receive PCV20. 3

Pediatric Indications

• Children should receive PCV20 as a 4-dose series at 2,4,6, and 12-15 months of age. 1
• Children and adolescents aged 15 months through 17 years with risk conditions should receive a single dose of PCV20. 1

Special Populations and Dosing Schedules

Hematopoietic Stem Cell Transplant Recipients

• Adults who received hematopoietic stem cell transplant should receive a 4-dose series of PCV20 starting 3-6 months after transplant, with the first 3 doses given 4 weeks apart, and the fourth dose at least 6 months after the third dose or at least 12 months after transplant, whichever is later. 3

Previously Vaccinated Adults

• Adults who previously received PPSV23 only should receive one dose of PCV20 at least 1 year after the last PPSV23 dose. 5, 3
• Adults who previously received PCV13 only should receive one dose of PCV20 at least 1 year after the PCV13 dose. 5, 3
• Adults who received both PCV13 and PPSV23 may receive PCV20 through shared clinical decision-making, administered ≥5 years after the last pneumococcal vaccine dose. 3, 4

Key Clinical Considerations

Completion of Vaccination Series

• After PCV20 administration, no additional pneumococcal vaccines are needed in most scenarios, as PCV20 provides comprehensive coverage. 3

Mortality Benefit

• Pneumococcal vaccination has been associated with a 22% reduction in all-cause mortality among adults with cardiovascular disease or very high cardiovascular risk. 3, 4

Contraindications

• PCV20 is contraindicated in individuals with severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid. 1

Premature Infants

• Apnea following intramuscular vaccination has been observed in some premature infants; decisions about timing should be based on individual infant's medical status and consideration of benefits versus risks. 1