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Home20 Serotypes20 SerotypesSerotype coverageCase CoverageDisease BurdenEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

Clinical Trial
Results

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Prescribing InformationPatient InformationIndications Patient Site
Demonstrated a consistent safety profileDemonstrated a consistent safety profileIn a phase 3 pivotal study, Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) demonstrated a safety profile consistent with Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])1In a phase 3 pivotal study, Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) demonstrated a safety profile consistent with Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])1
Percentage of participants with solicited adverse reactions within 7 days after vaccination1*†
Scroll left to view table
  Dose 1 Dose 2 Dose 3 Dose 4
Prevnar20®
(N=993)		 Prevnar13®
(N=974)		 Prevnar20®
(N=940)		 Prevnar13®
(N=924)		 Prevnar20®
(N=914)		 Prevnar13®
(N=901)		 Prevnar20®
(N=826)		 Prevnar13®
(N=815)
Any local reactions‡
Pain at injection site 49.1 45.3 44.0 41.7 38.6 39.0 35.7 35.8
Swelling 16.4 18.8 15.5 17.3 17.1 17.6 14.9 17.3
Redness 25.5 24.6 23.2 26.4 25.4 27.2 23.5 26.6
Any systemic reactions§
Fever 10.3 7.5 17.3 16.3 12.6 13.7 14.5 14.0
Decreased appetite 24.4 23.9 26.4 23.5 20.6 22.4 24.8 25.2
Irritability 70.9 71.7 71.6 68.8 64.4 63.0 61.0 61.1
Drowsiness 67.2 66.0 54.7 55.6 44.1 44.1 39.5 39.5
Study conducted in the United States, including Puerto Rico.Local reactions, systemic reactions, and use of antipyretic/pain medication were collected in the e-diary from Day 1 through Day 7 after each dose. If a severe reaction was identified by the investigator as a grade 4 reaction at a follow-up assessment, it was also reported as an adverse event. Any local reaction: any redness >0.0 cm, any swelling >0.0 cm, or any pain at the injection site after the specified dose. Any systemic reaction: any fever ≥38.0°C, any decreased appetite, any drowsiness, or any irritability after the specified dose.N=number of participants with any e-diary data reported after the specified dose. This value is the denominator for the percentage calculations.
Review the dosing schedule for Prevnar 20®
LoadingReference:Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023.
Manufactured by Wyeth Pharmaceuticals LLC.
Marketed by Pfizer Inc.
PP-PNR-USA-2906 © 2025 Pfizer Inc.
All rights reserved. April 2025
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INDICATIONS 
  • Prevnar 20® is a vaccine indicated 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
  • Both Prevnar 20® and Prevnar 13® are vaccines indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in individuals 6 weeks through 17 years of age
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine.
Important Safety Information
  • Do not administer Prevnar 20® or Prevnar 13® to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 20® or Prevnar 13® 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®
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to Prevnar 13®
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant’s medical status and the potential benefits and risks
  • For Prevnar 20®, in individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever
  • For Prevnar 20®, in individuals 15 months through 17 years of age vaccinated with a single dose, the most commonly reported solicited adverse reactions (>10%) were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever
  • For Prevnar 13®, in individuals 6 weeks through 17 years of age, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
  • For Prevnar 13®, in individuals 6 weeks through 17 years of age, the most common side effects were irritability, decreased appetite, decreased or increased sleep, fever, and injection site tenderness, redness, or swelling
  • In individuals 6 years through 17 years of age, Prevnar 13® is administered as a single dose
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® is a vaccine indicated 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
  • Both Prevnar 20® and Prevnar 13® are vaccines indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in individuals 6 weeks through 17 years of age
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine.