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Burden of disease

Pneumococcal pneumonia and IPD are a serious risk for adult patients1-4

Pneumococcal pneumonia is the most common clinical manifestation of pneumococcal disease in adults. It leads to 150,000 US hospitalizations annually and is estimated to account for 10 to 30% of all adult community-acquired pneumonia (CAP) cases in the US.5 CAP occurs when someone develops pneumonia outside of a hospital.6

Pneumococcal pneumonia leads to 150,000 hospitalizations annually in the US5 

The same bacteria that cause pneumococcal pneumonia, Streptococcus pneumoniae, can invade normally sterile sites in the body, such as the blood or cerebrospinal fluid. When this occurs, it is referred to as IPD. IPD is a serious illness that can lead to hospitalization, complications including bacteremia and meningitis, and sometimes death.5

In the US, IPD is ~4x more likely to lead to death in adults over the age of 65, compared to those aged 18-647,a

Annual rate of IPD in US adults, 2018-20217,a

The Annual Rate of IPD Cases per 100,000: 6.7 in Ages 18-64, 17.5 in Ages 65+. The Rates of IPD for Adults Aged 65+ Were ~3X Higher Than Adults 18-64 Years.

The serotypes that cause the majority of IPD cases in US adults have shifted over time1

Nearly half of all IPD cases in adults 65+

are caused by serotypes not included in any other PCV approved for adults1,8,b

These values are based on CDC epidemiologic data and do not reflect the efficacy of any pneumococcal vaccines.9

Adults may benefit from a PCV designed to cover serotypes responsible for the most adult IPD cases10

Review IPD case coverage

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aBased on CDC ABC surveillance data from the years 2018–2021, representing ~35 million persons and 10 states across the US.8,11-14

bOther approved PCVs include PCV13, PCV15, and PCV20.1

ABC, Active Bacterial Core; CAP, community acquired pneumonia; CDC, Centers for Disease Control and Prevention; IPD, invasive pneumococcal disease; PCV, pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PCV15, 15-valent pneumococcal conjugate vaccine; PCV20, 20-valent pneumococcal conjugate vaccine; US, United States.

References:
 

  1. ABCs bact facts interactive data dashboard. SPN serotypes 1998-2022. Centers for Disease Control and Prevention. May 22, 2024. Accessed June 20, 2024. https://www.cdc.gov/abcs/bact-facts/data-dashboard.html
  2. Grant LR, Meche A, McGrath L, et al. Risk of pneumococcal disease in US adults by age and risk profile. Open Forum Infect Dis. 2023;10(5):ofad192. doi:10.1093/ofid/ofad192
  3. Grant LR, Meche A, McGrath L, et al. Supplementary material to: Risk of pneumococcal disease in US adults by age and risk profile. Open Forum Infect Dis. 2023;10(5):ofad192. doi:10.1093/ofid/ofad192
  4. Clinical features of pneumococcal disease. Centers for Disease Control and Prevention. February 6, 2024. Accessed May 21, 2024. https://www.cdc.gov/pneumococcal/hcp/clinical-signs/
  5. Gierke R, Wodi P, Kobayashi M. Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). 14th edition. Chapter 17: Pneumococcal disease. Centers for Disease Control and Prevention. May 1, 2024. Accessed July 23, 2024. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html
  6. About pneumonia. Centers for Disease Control and Prevention. October 17, 2023. Accessed May 22, 2024. https://www.cdc.gov/pneumonia/about/
  7. 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-00407.
  8. 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-00408.
  9. 1998-2021 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 2021. Centers for Disease Control and Prevention. Last updated May 17, 2024. Accessed June 14, 2024. https://data.cdc.gov/Public-Health-Surveillance/1998-2021-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/data
  10. Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977. World Health Organization. October 19, 2013. Accessed March 5, 2024. https://www.who.int/publications/m/item/pneumococcal-conjugate-vaccines-annex3-trs-977
  11. 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
  12. 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
  13. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae, 2020. Centers for Disease Control and Prevention. Updated September 20, 2022. Accessed January 4, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2020.pdf
  14. 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
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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.