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IPD case coverage for adults

Serotypes covered by CAPVAXIVE vs PCV20

CAPVAXIVE is the only FDA-approved PCV that helps protect against serotypes responsible for ~84% of IPD cases in adults 50 years and older, compared to ~52% by PCV20 at a national level.1-3,a

Proportion of IPD coverage by CAPVAXIVE and PCV20 serotypes in adults aged ≥50 years at a national level, 2018-20221-3,a

Approximate % of IPD Cases Covered at a National Level: ~9% Non-Vaccine Type, and ~52% for PCV20 Serotypes (45.9% Shared & 6.5% PCV20, Non CAPVAXIVE) vs ~84% CAPVAXIVE Serotypes (45.9% Shared & 37.8% CAPVAXIVE, Non PCV20)

These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines.3 There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.

In certain at-risk populations in Alaska, Colorado, New Mexico, Oregon, and the Navajo Nation, a higher prevalence of IPD caused by serotype 4, which is not included in CAPVAXIVE, has been reported. IPD surveillance from other geographic areas in the US has not detected significant percentages of serotype 4.4

CAPVAXIVE, non-PCV20 serotypes: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, 35B2
Shared serotypes: 3, 6A, 7F, 8, 10A, 11A, 12F, 15B, 19A, 22F, 33F
PCV20, non-CAPVAXIVE serotypes: 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F

The 11 serotypes covered by CAPVAXIVE that are not covered by PCV20 contribute to ~38% of IPD cases in adults over 50 at a national level.1-3

The 9 serotypes covered by PCV20 that are not covered by CAPVAXIVE make up ~7% of IPD cases in adults over 50 at a national level.1-3

Serotypes included in CAPVAXIVE vs other pneumococcal vaccines2,b

CAPVAXIVE includes 8 unique serotypes that are not included in any other pneumococcal vaccine. These 8 unique serotypes are responsible for ~27% of IPD cases in adults 50 years of age and older at a national level.1-3,a,b

The 8 unique serotypes in CAPVAXIVE are responsible for ~27% of IPD cases in adults 50 years of age and older at a national level1-3,a

Serotypes 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B

These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines.3 There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20.

Phase 3 clinical trials

CAPVAXIVE was studied in a broad range of adults. Learn about the immune responses observed.

View clinical studies

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aBased on CDC ABC surveillance data from the years 2018–2022, representing ~35 million persons and 10 states across the US. Regional variations may exist.1,3-9

bOther available pneumococcal vaccines include PCV15, PCV20, and PPSV23.2

ABC, Active Bacterial Core; CDC, Centers for Disease Control and Prevention; IPD, invasive pneumococcal disease; PCV, pneumococcal conjugate vaccine; PCV15, 15-valent pneumococcal conjugate vaccine; PCV20, 20-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine; US, United States.

References:

  1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-PVV-00504.
  2.  ABCs bact facts interactive data dashboard. SPN serotypes 1998-2022. Centers for Disease Control and Prevention. Last Updated August 28, 2024. Accessed October 16, 2024. https://www.cdc.gov/abcs/bact-facts/data-dashboard.html
  3. 1998-2022 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance, ages 18-49, 50-64, 65 plus, year is between 2018 and 2022. Centers for Disease Control and Prevention. Last updated July 22, 2024. Accessed August 14, 2024. https://data.cdc.gov/Public-Health-Surveillance/1998-2022-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/data
  4. Kobayashi M, Leidner AJ, Gierke R, et al. Use of 21-valent pneumococcal conjugate vaccine among U.S. adults: recommendations of the Advisory Committee on Immunization Practices — United States, 2024. MMWR Morb Mortal Wkly Rep. 2024;73(36):793-798. doi:10.15585/mmwr.mm7336a3
  5. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2018. Centers for Disease Control and Prevention. Updated May 22, 2020. Accessed June 14, 2024. https://stacks.cdc.gov/view/cdc/140450
  6. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2019. Centers for Disease Control and Prevention. Updated June 16, 2021. Accessed January 4, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2019.pdf
  7. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2020. Centers for Disease Control and Prevention. Updated September 20, 2022. Accessed October 15, 2024. https://stacks.cdc.gov/view/cdc/140328
  8. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2021. Centers for Disease Control and Prevention. Updated June 2, 2023. Accessed January 4, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2021.pdf
  9. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2022. Centers for Disease Control and Prevention. Updated July 5, 2024. Accessed September 4, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2022.pdf
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Indications

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
  • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Select Safety Information

Do not administer CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.
 
Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.
 
The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).
 
The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).
 
Vaccination with CAPVAXIVE may not protect all vaccine recipients.

Before administering CAPVAXIVE, please read the accompanying Prescribing Information. The Patient Information also is available.

Indications

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.
  • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.

The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A,

CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A,

Select Safety Information

Do not administer CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.
 
Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.
 
The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%).
 
The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%).
 
Vaccination with CAPVAXIVE may not protect all vaccine recipients.

Before administering CAPVAXIVE, please read the accompanying Prescribing Information. The Patient Information also is available.

Do not administer CAPVAXIVE to individuals with a history of a severe

Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.