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Prescribing InformationIndicationPatient SiteOrder Prevnar 20®
Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) CAPiTA results were consistent with an RWE study1,2
RWE study description1:

Test-negative design (TND): a well-established measure of vaccine effectiveness

  • Minimizes bias caused by differences among cases and controls
  • Helps to ensure a representative patient population
  • Commonly used to assess vaccine effectiveness


Study limitations

  • Observational in nature
  • Low Prevnar 13 uptake in study (~14%)
  • Serotype-specific vaccine effectiveness and stratified analyses not possible
  • May be susceptible to selection bias or confounding factors
  • Overall number of CAP cases was relatively small (n=68)
CAP surveillance study population
Adults aged 18 or older admitted for CAP at 1 of 9 hospitals in Louisville, Kentucky.1 
RWE study population
Immunocompromised patients were included in the RWE study population but were not studied in the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA).1,2
* Adults aged 65 years or older with CAP and pneumococcal vaccination history confirmed by electronic health records enrolled between April 2015 and April 2016 (N=2034).1
CAPiTA results were consistent with an RWE study1,2
The RWE study of Prevnar 13 was conducted as a nested case-control study in US adults using a TND (N=2034)1
CAPiTA primary end point2:
 statistically significant
RISK REDUCTION 

(95.2% CI, 21.8-62.5)
Statistically significant risk reduction 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).
RWE primary end point1: RISK REDUCTION

(95% CI, 12.8-91.5)
Risk reduction of vaccine-type CAP hospitalization.
 CAP=community-acquired pneumonia; CAPiTA=Community-Acquired Pneumonia Immunization Trial in Adults; RWE=real-world effectiveness.References: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. N Engl J Med. 2015;372(12):1114-1125. 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. Clinical studies Prevnar 20® was built on the efficacy of Prevnar 131-4 See the CAPiTA study Loading Order Prevnar 20 for your office by registering for Prime Get started Loading CAP=community-acquired pneumonia; CAPiTA=Community-Acquired Pneumonia Immunization Trial in Adults; RWE=real-world effectiveness.
References: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. N Engl J Med. 2015;372(12):1114-1125. Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
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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