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Home20 Serotypes20 SerotypesSerotype coverageCase CoverageDisease BurdenEfficacyEfficacyInvasive Pneumococcal DiseaseOtitis MediaClinical Trial Results

Clinical Trial
Results

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Help protect babies from the serious threat of invasive pneumococcal disease (IPD) and otitis media (OM)1A substantial number of IPD cases are caused by a limited number of Streptococcus pneumoniae serotypes1:Help protect babies from the serious threat of invasive pneumococcal disease (IPD) and otitis media (OM)1A substantial number of IPD cases are caused by a limited number of Streptococcus pneumoniae serotypes1:

IPD is a concerning disease in young children. It can present as serious manifestations that include:

 Meningitis

S. pneumoniae is the leading cause of bacterial meningitis among children 
<5 years of age in the United States1

Bacteremia

Bacteremia without a known site of infection is the most common invasive clinical presentation of pneumococcal infection among children <2 years of age1

S. pneumoniae is one of the most common causes of OM, which can be problematic in young children1,2
S. pneumoniae is one of the most common causes of OM, which can be problematic in young children1,2

OM is one of the most frequent reasons for pediatric office visits, resulting in more than 10 million pediatric office visits annually.3

OM is:

 

A leading cause of ER visits4,5
A common reason for antibiotic use in children <5 years of age, which can lead to resistance6-9
The most common reason for surgery6
A cause of hearing loss or impairment10

A leading cause of ER visits4,5

A common reason for antibiotic use in children <5 years of age, which can lead to resistance6-9

The most common reason for surgery6

A cause of hearing loss or impairment10

See how Prevnar 20® is built on established vaccines11
References:Gierke R. Current epidemiology of pneumococcal disease and pneumococcal vaccine coverage among children, United States. Centers for Disease Control and Prevention. February 24, 2022. Accessed February 1, 2023. https://stacks.cdc.gov/view/cdc/114840.Pichichero ME. Recurrent and persistent otitis media. Pediatr Infect Dis J. 2000;19(9):911-916.Gierke R, Wodi AP, Kobayashi M. Pneumococcal disease. In: Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. Centers for Disease Control and Prevention. Updated August 18, 2021. Accessed October 28, 2022. https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html.Wier LM, Yu H, Owens PL, Washington R. Statistical brief #157: overview of children in the emergency department, 2010. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Agency for Healthcare Research and Quality (US). Published June 2013. Accessed April 17, 2023. https://www.ncbi.nlm.nih.gov/books/NBK154386/.Healthcare Cost and Utilization Project. Emergency department national statistics. Report created June 1, 2022. https://datatools.ahrq.gov/hcupnet.Marom T, Tan A, Wilkinson GS, Pierson KS, Freeman JL, Chonmaitree T. Trends in otitis media–related health care use in the United States, 2001-2011. JAMA Pediatr. 2014;168(1):68-75.Kono M, Umar NK, Takeda S, et al. Novel antimicrobial treatment strategy based on drug delivery systems for acute otitis media. Front Pharmacol. 2021;12:640514.Centers for Disease Control and Prevention. How antibiotic resistance happens. Reviewed October 5, 2022. Accessed February 1, 2023. https://www.cdc.gov/drugresistance/about/how-resistance-happens.html.Munita JM, Arias CA. Mechanisms of antibiotic resistance. Microbiol Spectr. 2016;4(2):10.1128/microbiolspec.VMBF-0016-2015.Schilder AGM, Chonmaitree T, Cripps AW, et al. Otitis media. Nat Rev Dis Primers. 2016;2(1):16063.Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2023.
Manufactured by Wyeth Pharmaceuticals LLC.
Marketed by Pfizer Inc.
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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.