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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 adults1Safety profile for pneumococcal vaccine-naïve adults1Percentage of participants in Study 1 with solicited adverse reactions within 7-10 days after vaccination in pneumococcal vaccine-naïve adults1*
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  18-49 Years of Age 50-59 Years of Age ≥60 Years of Age
Local reaction Prevnar 20 (n=335) %​ PCV13 (n=112) % Prevnar 20 (n=331) % PCV13 (n=111) % Prevnar 20/Saline (n=1505) % PCV13/ PPSV23 (n=1483) %
Pain at injection site§ 81.2 82.1 72.5 69.4 55.4 54.1
Swelling (>2.0 cm)§¶ 11.6 12.5 8.8 10.8 7.5 8.0
Redness (>2.0 cm)§¶ 9.0 9.8 8.2 5.4 7.3 6.2
Any local reaction|| 81.2 82.1 72.8 70.3 57.4 56.0
 
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  18-49 Years of Age 50-59 Years of Age ≥60 Years of Age
Systemic ​​reaction​​​‡ Prevnar 20 (n=335) %​ PCV13 (n=112) % Prevnar 20 (n=331) % PCV13 (n=111) % Prevnar 20/Saline (n=1505) % PCV13/ PPSV23 (n=1483) %
Muscle pain** 66.6 74.1 49.8 49.5 39.1 37.3
Fatigue** 42.7 43.8 39.3 36.0 30.2 30.7
Headache** 38.8 33.9 32.3 36.0 21.5 23.3
Joint ​​​​​​pain** 13.4 17.9 15.4 20.7 12.6 13.7
Fever (≥38.0˚C) 1.2 1.8 1.5 0.9 0.9 0.8
Any systemic reaction†† 79.4 83.0 69.5 67.6 55.2 55.4
Use of antipyretic or pain medication‡‡ 25.7 23.2 24.5 27.9 18.5 20.4
PCV13=Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]); PPSV23=23-valent pneumococcal polysaccharide vaccine.Study 1 was conducted in the U.S. and in Sweden.Local reactions measured within 10 days after vaccination; systemic reactions measured within 7 days after vaccination.Includes all participants who reported a reaction as mild, moderate, or severe during Day 1 to Day 10 after vaccination.“Any local reaction” includes all participants who reported any injection site reaction (pain, swelling, or redness) as mild, moderate, or severe during Day 1 to Day 10 after vaccination.Diameters were measured in caliper units (0.5 cm) of whole numbers from 1 to 21 or 21+. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling was characterized as: mild is >2.0 to 5.0 cm; moderate is >5.0 to 10.0 cm; severe is >10.0 cm.Includes all participants who reported a reaction as mild, moderate, or severe during Day 1 to Day 7 after vaccination.“Any systemic reaction” includes all participants who reported any fever ≥38°C or any other systemic reaction (fatigue, headache, joint pain, or muscle pain) as mild, moderate, or severe during Day 1 to Day 7 after vaccination.Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (ie, number of reactions reported).Reference:Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2021.
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November 2022
Clinical studies

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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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