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HomePrevnar 20TMPrevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine)Broad pneumococcal defenseMOABurden of diseaseIPDCAPACIP recommendationsACIP recommendationsACIP recommendationsPatient profilesClinical studies

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Study 1Study 1Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) immunogenicity in pneumococcal vaccine-naïve adults1Study 1: Demonstrated noninferior immunogenicity* in pneumococcal vaccine-naïve adult patients age 60 or older1Immunogenicity measured for the 20 serotypes in Prevnar 20 compared to Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein)] and PPSV23 for shared serotypes1
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 13.1Study 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 serotypes1GMFR=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, 2021.Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
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November 2022
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INDICATIONS AND SELECT SAFETY INFORMATION
  • Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is indicated for active immunization for the prevention of pneumonia and 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 adults 18 years of age and older
  • The indication of Prevnar 20® for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F 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
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

SELECT SAFETY INFORMATION
 
  • Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20®, Prevnar 13®, or to diphtheria toxoid is a contraindication
  • 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
  • Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20®, Prevnar 13®, or to diphtheria toxoid is a contraindication
  • 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®
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to Prevnar 13®
  • For Prevnar 20®, in adults 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 adults 18 through 59 years of age  
  • For Prevnar 13®, in adults 18 years of age and older, the most commonly reported solicited adverse reactions (>5%) were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
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.

Please click for Prevnar 13® Full Prescribing Information.
Indications
  • Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is indicated for active immunization for the prevention of pneumonia and 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 adults 18 years of age and older
  • The indication of Prevnar 20® for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F 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
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diptheria CRM197 Protein]) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

Please click for Prevnar 20™ Full Prescribing Information.

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