The Newest 21-Valent Pneumococcal Conjugate Vaccine
The newest 21-valent pneumococcal conjugate vaccine is called CAPVAXIVE (PCV21), manufactured by Merck Sharp & Dohme, LLC, which was licensed by the FDA on June 17,2024, for use in persons aged ≥18 years. 1
Key Information About PCV21 (CAPVAXIVE)
PCV21 represents the latest advancement in pneumococcal vaccines, offering expanded serotype coverage compared to previous pneumococcal conjugate vaccines. Here's what makes it significant:
- Manufacturer: Merck Sharp & Dohme, LLC
- FDA Approval Date: June 17,2024
- Approved Age Group: Adults aged 18 years and older
- Serotype Coverage: Contains 21 pneumococcal serotypes, including eight new serotypes not found in other currently licensed vaccines 1
Serotype Coverage Comparison
PCV21 differs from other pneumococcal vaccines in its serotype coverage:
Notable Addition: PCV21 includes eight new serotypes not contained in previous vaccines, which account for approximately 20-30% of invasive pneumococcal disease (IPD) cases among adults with indications for vaccination 1
Important Omission: Unlike PCV15, PCV20, and PPSV23, PCV21 does not contain serotype 4, which has recently reemerged as a cause of IPD in certain regions of the western United States 1
Clinical Recommendations
The Advisory Committee on Immunization Practices (ACIP) has recommended PCV21 as an option for adults who are currently recommended to receive pneumococcal conjugate vaccines:
- For adults aged ≥65 years who have not received PCV or whose vaccination history is unknown
- For adults aged 19-64 years with risk conditions who have not received PCV or whose vaccination history is unknown 1, 2
Geographic Considerations
When choosing between available pneumococcal vaccines, geographic location may be important:
Western U.S. Consideration: In regions where serotype 4 has reemerged (Alaska, Colorado, Navajo Nation, New Mexico, Oregon), other recommended pneumococcal vaccines (PCV20 or PCV15+PPSV23) may provide broader coverage against locally circulating strains compared to PCV21 1
Risk Factors: Adults with specific risk factors (alcoholism, chronic lung disease, cigarette smoking, homelessness, injection drug use) who have not received a pneumococcal conjugate vaccine may benefit from vaccines containing serotype 4 1
Public Health Impact
The introduction of PCV21 is expected to:
- Prevent additional disease caused by pneumococcal serotypes unique to PCV21
- Help address racial disparities in pneumococcal disease, which are primarily due to non-PCV13 serotypes, many of which are included in PCV21 1
Important Considerations
- PCV21 is part of an evolving landscape of pneumococcal vaccines that continues to expand coverage against disease-causing serotypes
- The CDC and ACIP will continue to monitor safety and public health impact of all pneumococcal conjugate vaccines (PCV15, PCV20, and PCV21) 1
- Recommendations may change as pneumococcal disease epidemiology evolves and more data becomes available
The addition of PCV21 (CAPVAXIVE) to the available pneumococcal vaccines represents an important advancement in the prevention of invasive pneumococcal disease, with potential to reduce morbidity and mortality associated with pneumococcal infections.