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Prescribing InformationIndicationPatient SiteOrder Prevnar 20®
Study 1Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) immunogenicity in pneumococcal vaccine-naïve adults1
Study 1 results: Demonstrated strong immunogenicity* in pneumococcal vaccine-naïve adult patients age 60 or older1
Prevnar 20 immunogenicity was noninferior for all shared serotypes with Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and 6 of 7 shared serotypes with PPSV23.1
Immune responses elicited by Prevnar 20 (n=1157-1430) met noninferiority criteria for all shared serotypes with Prevnar 13 (n=1390-1419) and 6 of 7 shared serotypes with PPSV23 (n=1201-1319). The response to serotype 8 missed the prespecified statistical noninferiority criterion by a small margin (the lower bound of the 2-sided 95% CI for the GMT ratio being 0.49 vs >0.50). In supportive analyses, 77.8% of participants in the Prevnar 20 group achieved a ≥4-fold rise in serotype 8 OPA titers from before vaccination to 1 month post-vaccination.1
CI=confidence interval; GMT=geometric mean titer; OPA=opsonophagocytic activity; PPSV23=23-valent pneumococcal polysaccharide vaccine.OPA GMTs 1 month after vaccination with Prevnar 20 vs control vaccine.1PPSV23 and Prevnar 20 have 19 shared serotypes. The 7 shared serotypes evaluated are unique to PPSV23 and Prevnar 20, and are not contained in Prevnar 13.1
Study 1 results: Demonstrated immunobridging* in pneumococcal vaccine-naïve adults age 18-591

The effectiveness of Prevnar 20 in adults age 18-49 and 50-59 was inferred by comparing the immune response to each of the 20 vaccine serotypes in each of these age groups (immunobridging) to the corresponding serotype-specific immune responses in adults age 60-64.1

Immunogenicity for 20 serotypes in Prevnar 20 compared to Prevnar 13 and PPSV23 for shared serotypes1 GMFR=geometric mean fold rise.OPA GMTs 1 month after vaccination with Prevnar 20.PPSV23 and Prevnar 20 have 19 shared serotypes. The 7 shared serotypes evaluated are unique to PPSV23 and Prevnar 20, and are not contained in Prevnar 13.References: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.
Clinical studies Prevnar 20 was built on the efficacy of Prevnar 13. 1,2 See the CAPITA studyLoading With 20 serotypes in its pneumococcal conjugate vaccine, you can help protect your eligible adult patients. 1 Explore additional protection Loading
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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