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HomeEfficacyEffectivenessAcute Otitis MediaSafety & DosingSafety & DosingSafety ProfileDosing & AdministrationImmunogenicityAdherenceSupport & OrderSupport & OrderOrder Prevnar 13®EventsMaterialsVideosResourcesRequest a representative
Efficacy: IPD Reduction

97.4% reduction in IPD per protocol (95% CI: 82.7%-99.9%) in babies fully vaccinated per CDC-recommended schedule in a randomized controlled trial (RCT) of 37,816 infants receiving PCV7 or a control vaccine at 2, 4, 6, and 12 to 15 months of age followed from October 1995 to April 1999. Vaccine efficacy of 93.9% (95% Cl: 79.6%-98.5%) was shown in the ITT population. Prevnar 13® was licensed on the basis of immunogenicity endpoints. Efficacy of Prevnar 13® was inferred by showing noninferiority to PCV7.1,2 

EffectivenessIPD surveillance dataOnly Prevnar* has demonstrated effectiveness, with a substantial 98% reduction of vaccine-type IPD in children <5 years of age3*Prevnar 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 2010.1
  • The introduction of Prevnar* resulted in a reduction in vaccine-type IPD, from 88 cases per 100,000 children <5 years of age in 1998 to 2 cases per 100,000 children in 20193
  • From 2000-2019, Prevnar* reduced the burden of IPD by providing coverage that has prevented more than 16,000 cases of meningitis, 172,000 cases of bacteremia, and 55,000 cases of bacteremic pneumonia and empyema in babies4
ReferencesCDC surveillance data are observational data only based on incidence rates from 1998 through 2019 collected through the National Notifiable Diseases Surveillance System (NNDSS) and the Active Bacterial Core surveillance (ABCs) system run by the CDC.3IPD can be caused by more than 90 identified Streptococcus pneumoniae serotypes. In 2000, PCV7 was licensed and indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F); from 1978 through 1994, these 7 serotypes were responsible for approximately 80% of IPD cases in children <6 years of age in the United States.5In 2010, Prevnar 13® was approved 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.1CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease. In a CDC-sponsored observational case-control study to assess vaccine effectiveness (VE)IPD can present in multiple forms. There are 3 major clinical syndromes of IPD: meningitis, bacteremia, and bacteremic pneumonia.6

Prevnar 13® provided an 88.6% reduction in bacteremic pneumonia (95% CI: 75.9%- 94.6%)7

STUDY DESCRIPTION:
  • Children 2-59 months of age with vaccine-type IPD (n=722 cases) were compared with matched controls (n=2991)
  • VE was assessed based on 1 or more doses of Prevnar 13®
  • Cases were identified through the ABCs system from May 2010 to May 2014
  • Study limitations:
    • Observational in nature
    • PCV7 and Prevnar 13® administration indistinguishable in some cases
    • Relatively small number of discordant pairs for analysis
    • Inability to contact a substantial number of cases and controls
Bacteremic pneumonia accounts for 25%-30% of IPD in children ≤2 years of age6
  • Streptococcus pneumoniae is the most common cause of community-acquired cases of bacteremic pneumonia8
Bacteremic pneumonia can pose serious risks of complications in infants and younger children9
  • Bacteremic pneumonia can present clinically in children as severe respiratory distress requiring mechanical ventilation and can lead to respiratory failure, pleural effusions, pleural empyema, and meningitis9
Next: Acute Otitis Media LoadingReferences:Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.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.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.Wasserman MD, Perdrizet J, Grant L, et al. Clinical and economic burden of pneumococcal disease due to serotypes contained in current and investigational pneumococcal conjugate vaccines in children under five years of age. Infect Dis Ther. 2021;10(4):2701-2720. Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2009.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.Moore MR, Link-Gelles R, Schaffner W, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine for prevention of invasive pneumococcal disease in children in the USA: a matched case-control study. Lancet Respir Med. 2016;4(5):399-406.Fritz CQ, Edwards KM, Self WH, et al. Prevalence, risk factors, and outcomes of bacteremic pneumonia in children. Pediatrics. 2019;144(1):e20183090.Tan TQ. Pediatric invasive pneumococcal disease in the United States in the era of pneumococcal conjugate vaccines. Clin Microbiol Rev. 2012;25(3):409-419. doi:10.1128/CMR.00018-12.

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