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Burden of IPD

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Dosing

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Efficacy

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Efficacy

IPD reduction

In a clinical study of 37,816 infants, Prevnar® (PCV7)* provided a 97.4% reduction in IPD in the per protocol population (95% CI: 82.7%-99.9%)

Model used for illustrative purposes only.

Prevnar 13® (versus PCV7) offers protection against 6 additional serotypes responsible for causing IPD1

    *Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).

    †PCV7 contains the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Prevnar 13® contains these 7 serotypes and additional serotypes 1, 3, 5, 6A, 7F, and 19A.​​​​​​​

  CDC=Centers for Disease Control and Prevention; ITT=intent-to-treat.

Study description

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-April 1999. Vaccine efficacy of 93.9% (95% CI: 79.6%-98.5%) was shown in the ITT population.1

Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) was licensed on the basis of immunogenicity endpoints. Efficacy of Prevnar 13® was inferred by showing noninferiority to PCV7. 

Additionally, in a CDC-sponsored observational case-control study to assess vaccine effectiveness (VE)

Prevnar 13® provided an 88.6% reduction in bacteremic pneumonia (95% CI: 75.9%-94.6%)3

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

ABCs=Active Bacterial Core surveillance; CDC=Centers for Disease Control and Prevention; PCV=pneumococcal conjugate vaccine.

Acute otitis media (AOM)

Middle ear infections are the most frequent reasons for pediatric office visits in the United States, resulting in more than 20 million visits annually4

  • ​​​​​​​Pneumococci are a common cause of AOM and are detected in 28% to 55% of middle ear aspirates4

  • Prevnar 13® is indicated for active immunization for the prevention of otitis media caused by Streptococcus 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 19A1
  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine1
  • 54% vaccine efficacy in a Prevnar® (PCV7)* clinical trial (N=1662) against AOM episodes due to vaccine serotypes in the intent-to-treat population1‡

** This is an optional area where footnotes can live.

Model used for illustrative purposes only.

AOM poses a burden on children

Based on a claims analysis study between 2001 and 2011 of children 6 years of age or younger:

AOM is the most common reason children take antibiotics5

AOM is the most common reason children have surgery5

    ‡Double-blind trial in which 1662 infants were equally randomized to receive either PCV7 or a control vaccine, Recombivax HB (Hepatitis B Vaccine [Recombinant]), at 2, 4, 6, and 12 to 15 months of age.

Recombivax HB is a registered trademark of Merck & Co., Inc.

IPD surveillance data

CDC surveillance data: Observed disease reduction6

US incidence of IPD among children <5 years of age has declined since the introduction of Prevnar® (PCV7)* and Prevnar 13®6

CDC surveillance data are observational data only. A direct effect of Prevnar 13® cannot necessarily be determined from these data.

IPD 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.7

In 2010, Prevnar 13® was licensed 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.1

Prevnar 13® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.1

Based on incidence rates from 1998 through 2016 collected through the National Notifiable Diseases Surveillance System (NNDSS) and the Active Bacterial Core surveillance (ABCs) system run by the CDC.6

CDC=Centers for Disease Control and Prevention.


References:
  1. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.  
  2. 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.
  3. 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.   
  4. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. In: Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington, DC: Public Health Foundation; 2015:275-296.
  5. 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.
  6. Centers for Disease Control and Prevention. Pneumococcal Disease Surveillance and Reporting. https://www.cdc.gov/pneumococcal/surveillance.html. Updated July 17, 2018. Accessed October 27, 2019.   
  7. Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2009.

Efficacy & Safety

  • Efficacy
  • Safety Profile
  • Immunogenicity

Dosing

Review the CDC-recommended dosing schedule for Prevnar 13®

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Impact of late doses

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PREVNAR 13® is a registered trademark of Wyeth LLC.
Manufactured by Wyeth Pharmaceuticals Inc.
© 2021 Pfizer Inc.
  • 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

IndicationS

  • 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

Please see full Prescribing Information.

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