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HomePrevnar 20®Prevnar 20®Serotypes matterAdministrationBurden of diseaseBurden
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Prescribing InformationIndicationPatient SiteOrder Prevnar 20®
Built on established efficacy of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])1-4~85,000

adults aged 65 or older participated in CAPiTA: Community-Acquired Pneumonia Immunization Trial in Adults.1-3​​

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CAPiTAStudy end points
Adults aged 65 or older1,3Primary1
  • A double-blind, randomized, parallel-group, placebo-controlled vaccine efficacy trial 
  • 84,496 immunocompetent adults aged 65 or older
  • 59 sites throughout the Netherlands conducted surveillance 
  • 3.93 years—median duration of follow-up
  • Prevention of a first episode of confirmed vaccine-type CAP defined as a positive vaccine-type specific urinary antigen test or isolation of vaccine-type Streptococcus pneumoniae from blood or another sterile site
Adults were excluded if they5Secondary1
  • Had immunocompromising conditions
  • Received immunosuppressive therapy
  • Resided in a long-term care facility
  • Required semi-skilled nursing care
  • Prevention of a first episode of vaccine-type CAP for which the result of a blood culture and results of cultures of any other sterile site were negative for S. pneumoniae
  • Prevention of a first episode of vaccine-type IPD in which the presence of S. pneumoniae was detected in a sterile site
Primary end point1:

statistically significant
RISK REDUCTION

(95.2% CI, 21.8-62.5) of a first episode of either vaccine-type nonbacteremic/noninvasive or vaccine-type bacteremic/invasive pneumococcal CAP (number of episodes: Prevnar 13 n=49; placebo n=90).

Secondary end points1:

statistically significant
RISK REDUCTION

(95.2% CI, 14.2-65.3) of a first episode of vaccine-type nonbacteremic/noninvasive pneumococcal CAP (number of episodes: Prevnar 13 n=33; placebo n=60).

statistically significant
RISK REDUCTION

(95.2% CI, 41.1-90.9) of a first episode of vaccine-type IPD (number of episodes: Prevnar 13 n=7; placebo n=28).

Safety profile for adults in the CAPiTA study2,5
Local adverse events (%) PCV13
(n=886-914*)		 Placebo
(n=859-865*)
Pain (any) 36.1† 6.1
Limitation of arm movement (any) 14.1† 3.2
Swelling (any) 6.8† 1.2
Redness (any) 4.9† 1.2
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Incidence of fever (%) PCV13
(n=881-896*)		 Placebo
(n=860-878*)
>100.4 °F 2.9† 1.3
100.4-101.1 °F 1.1 0.6
101.2-102.0 °F 0.6 0.2
102.1-104.0 °F 0.7 0.2
>104.0 °F 0.8 0.3
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Systemic adverse events (%)PCV13
(n=881-896*)		Placebo
(n=860-878*)
Fatigue18.8†14.8
New muscle pain‡18.4†8.4
Headache15.914.8
Chills9.48.4
Aggravated muscle pain‡9.1†4.4
New joint pain‡7.45.4
Decreased appetite5.33.7
Aggravated joint pain‡5.24.2
Rash3.3†0.8
Vomiting0.30.9
 

From the CAPiTA study, for a subset of 2011 subjects (1006 PCV13 and 1005 placebo recipients), solicited adverse reactions were monitored by recording local and systemic events using electronic diaries for 7 days after vaccination. Unsolicited adverse events were collected for 28 days after vaccination.2

Prevnar 20® real-world effectiveness study Learn more Loading CAP=community-acquired pneumonia; IPD=invasive pneumococcal disease; PCV13=13-valent pneumococcal conjugate vaccine; PP=pneumococcal pneumonia.Prevnar 13 will only help protect against Streptococcus pneumoniae serotypes in the vaccine.2*Number of patients with known values.2†P<0.05. No adjustments for multiplicity.2​​‡Generalized pain.2References: Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023.Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372(12):1114-1125.McLaughlin JM, Jiang Q, Isturiz RE, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older US adults: a test-negative design. Clin Infect Dis. 2018;67(10):1498-1506.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults: Supplementary appendix. N Engl J Med. 2015;372(11):1-74.Clinical studies With 20 serotypes in its pneumococcal conjugate vaccine, you can help protect your eligible adult patients1
Explore additional protection
Loading Order Prevnar 20 for your office by registering for Prime Get startedLoading CAP=community-acquired pneumonia; IPD=invasive pneumococcal disease; PCV13=13-valent
pneumococcal conjugate vaccine; PP=pneumococcal pneumonia.
Prevnar 13 will only help protect against Streptococcus pneumoniae serotypes in the vaccine.2
*Number of patients with known values.2
†P<0.05. No adjustments for multiplicity.2
‡Generalized pain.2 References: Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023.Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372(12):1114-1125.McLaughlin JM, Jiang Q, Isturiz RE, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older US adults: a test-negative design. Clin Infect Dis. 2018;67(10):1498-1506.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults: Supplementary appendix. N Engl J Med. 2015;372(11):1-74.
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INDICATION AND SELECT SAFETY INFORMATION
  • Prevnar 20® is a vaccine approved for:​​​​​
    • active immunization for the prevention of invasive disease caused by Streptococcus 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 6 weeks of age and older
    • active immunization for the prevention of 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 18 years of age and older
  • The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. 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 Prevnar 20® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
IMPORTANT SAFETY INFORMATION
  • Do not administer Prevnar 20® to individuals with severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or to diphtheria toxoid
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
  • In individuals 18 years of age and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site, muscle pain, fatigue, headache, and arthralgia. Additionally, injection site swelling was also reported (>10%) in individuals 18 through 59 years of age
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please click for Prevnar 20® Full Prescribing Information.INDICATION
  • Prevnar 20® is a vaccine approved for:
    • active immunization for the prevention of invasive disease caused by Streptococcus 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 6 weeks of age and older
    • active immunization for the prevention of 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 18 years of age and older
  • The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial