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HomeEfficacyEffectivenessAcute Otitis MediaSafety & DosingSafety & DosingSafety ProfileDosing & AdministrationImmunogenicityAdherenceSupport & OrderSupport & OrderOrder Prevnar 13®EventsMaterialsVideosResourcesRequest a representative
Full Prescribing Information Indications Patient Site
Prevnar* is the only pneumococcal conjugate vaccine (PCV) with proven efficacy, demonstrated effectiveness, and an established safety profile supported by more than 20 years of real-world experience1,2ReferencesPrevnar includes both Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and Prevnar 13®. In the US, PCV7 was available from 2000 to 2010, and PCV13 has been available since 2010.1Model used for illustrative purposes only.Only Prevnar® (PCV7) has proven efficacy against the serious threat of invasive pneumococcal disease (IPD)1

Prevnar 13® was licensed on the basis of immunogenicity endpoints. Efficacy of Prevnar 13® was inferred by showing noninferiority to PCV7.1 

 Learn more about efficacy Loading

Model used for illustrative purposes only.

 Only Prevnar* has demonstrated effectiveness, with a substantial 98% reduction of vaccine-type IPD in children <5 years old2†ReferencesPrevnar includes both Prevnar® (Pneumococcal 7-valent Conjugate Vaccine  [Diphtheria CRM197 Protein]) and Prevnar 13®. In the US, PCV7 was available 
 from 2000 to 2010, and PCV13 has been available since 2010.1CDC surveillance data are observational data only based on incidence rates from 1998 through 2019 collected through the National Notifiable Disease Surveillance System (NNDSS) and the Active Bacterial Core surveillance (ABCs) system run by the CDC.2 See additional effectiveness data LoadingPrevnar 13® is FDA-approved for the prevention of otitis media (OM).‡ OM is one of the most frequent reasons for pediatric office visits in the US annually1,3ReferencesStreptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.1 Find out more about OM Loading
References:
Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
Centers for Disease Control and Prevention. Pneumococcal Disease Surveillance and Reporting. Updated September 1, 2020. Accessed July 14, 2022. https://www.cdc.gov/pneumococcal/surveillance.html. 
Gierke R, Wodi AP, Kobayashi M, eds. Pneumococcal disease. In: Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. 14th ed.; Washington, DC: Public Health Foundation; 2021.Chapman R, Sutton K, Dillon-Murphy D, et al. Ten year public health impact of 13-valent pneumococcal conjugate vaccination in infants: a modelling analysis. Vaccine. 2020;38(45):7138-7145.Centers for Disease Control and Prevention. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59(9):258-261.American Academy of Pediatrics, Committee on Infectious Diseases. Policy statement––recommendations for the prevention of Streptococcus pneumoniae infections in infants and children: use of 13-valent pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23). Pediatrics. 2010;126(1):186-190.

PREVNAR 13® is a registered trademark of Wyeth LLC.
Manufactured by Wyeth Pharmaceuticals Inc.
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INDICATION AND LIMITATIONS OF USE
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F​​​​​​​​​​​​​​
  • In children 6 weeks through 17 years for invasive disease caused by the 13 serotypes, and for children 6 weeks through 5 years of age for otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)
Limitations of Use and Effectiveness
  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine
IMPORTANT SAFETY INFORMATIONIndications
  • Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine is a contraindication
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response
  • 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
  • In infants and toddlers, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most commonly reported solicited adverse reactions were injection site tenderness, redness, or swelling, irritability, decreased appetite, decreased or increased sleep, and fever
  • In children 6 years through 17 years of age, Prevnar 13® is administered as a single dose
Patients should always ask their doctors 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 www.vaers.hhs.gov or call 1-800-822-7967.Please see full Prescribing Information for Prevnar 13®.
  • Prevnar 13® is a vaccine indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F​​​​​​​
  • In children 6 weeks through 17 years for invasive disease caused by the 13 serotypes, and for children 6 weeks through 5 years of age for otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)​​​​​​​
​​​​​​​​​​​​​Limitations of Use and Effectiveness
  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine