What are the indications for the PCV-21 (Pneumococcal Conjugate Vaccine) vaccine?

Indications for PCV-21 Vaccine

PCV-21 (CAPVAXIVE) is indicated for all adults aged ≥65 years and adults aged 19-64 years with risk conditions for pneumococcal disease who have not received a pneumococcal conjugate vaccine (PCV) or whose vaccination history is unknown. 1

Primary Indications

PCV-21 was licensed by the FDA on June 17,2024, for use in persons aged ≥18 years. The Advisory Committee on Immunization Practices (ACIP) recommends PCV-21 as one of the options for pneumococcal vaccination in:

• All adults aged ≥65 years
• Adults aged 19-64 years with risk conditions who have not received PCV or have unknown vaccination history
• Adults who previously started their pneumococcal vaccination series with PCV13

As of October 2024, ACIP has expanded recommendations to include all PCV-naïve adults aged ≥50 years. 2

Risk Conditions for Pneumococcal Disease

Adults aged 19-64 years with the following conditions should receive PCV-21:

• Chronic medical conditions (heart, lung, liver disease)
• Diabetes mellitus
• Alcoholism
• Cigarette smoking
• Immunocompromising conditions including:
  • HIV infection
  • Functional or anatomic asplenia
  • Immunodeficiency
  • Solid organ transplantation
  • Hematologic malignancies
  • Immunosuppressive medications

Serotype Coverage

PCV-21 provides expanded serotype coverage compared to other pneumococcal vaccines:

• Contains 8 new serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B) not included in PCV13
• During 2018-2022, pneumococcal serotypes in PCV-21 caused approximately 80% of invasive pneumococcal disease (IPD) cases among adults with indications for vaccination 1
• The 8 new serotypes in PCV-21 accounted for 20-30% of IPD cases 1

Important Considerations

1. Serotype 4 absence: PCV-21 does not contain serotype 4, which is included in other pneumococcal vaccines (PCV15, PCV20, and PPSV23). This serotype has reemerged in certain regions, particularly the western United States, affecting adults aged <65 years with risk conditions, substance abuse history, or experiencing homelessness. 1

2. Racial disparities: Pneumococcal disease incidence is disproportionately higher in Black adults than non-Black adults. PCV-21's expanded coverage may help address remaining racial disparities primarily due to non-PCV13 serotypes. 1

3. Immunogenicity: PCV-21 has demonstrated robust immune responses for all 20 serotypes included in the vaccine, with geometric mean fold rises from baseline ranging from 6.0 to 113.4 in clinical trials. 3

Vaccination Algorithm

1. For adults ≥65 years or adults 19-64 years with risk conditions who are PCV-naïve:

   • Administer a single dose of PCV-21

2. For adults who previously received PCV13:

   • PCV-21 can be administered to provide protection against additional serotypes

3. For adults who previously received PPSV23:

   • PCV-21 can be administered to provide the benefits of a conjugate vaccine

4. For adults who previously received both PCV13 and PPSV23:

   • PCV-21 can be administered to provide protection against additional serotypes

Potential Impact

PCV-21 has the potential to significantly reduce the burden of pneumococcal disease in adults. Studies have shown that PCV-21 provides significantly greater coverage (78.9%) compared to PCV15 (42.7%), PCV20 (59.0%), and PPSV23 (70.4%) for adults across all Canadian geographic regions. 4

The eight unique serotypes in PCV-21 account for a higher proportion of IPD isolate serotypes in patients aged ≥65 years (26.8%) than in younger adults (19.7%), making this vaccine particularly valuable for older adults. 4