Scroll for Important Safety Information and Indications
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
IMPORTANT SAFETY INFORMATION AND INDICATIONS
  • 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
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
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®.

Reference:

1.Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals, Inc, 2016.

Rates of IPD

Clinical studies
In a clinical study of 37,816 patients randomized to Prevnar®* (PCV7) or a control vaccine, PCV7 demonstrated powerful efficacy against IPD in patients fully vaccinated with the 4-dose series1†
Percentage of reduction of IPD

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

  • Study description 

    This study was a randomized, double-blind, clinical trial in a multiethnic population at Northern California Kaiser Permanente from October 1995 through August 20, 1998, in which 37,816 infants were randomized to receive either PCV7 or a control vaccine at 2, 4, 6, and 12 to 15 months of age. Data accumulated through an extended follow-up period to April 20, 1999, resulted in efficacy estimates of 97.4% in the per-protocol analysis (95% CI: 82.7%-99.9%) and 93.9% in the intent-to-treat (ITT) analysis (95% CI: 79.6%-98.5%).1

Based on the existing efficacy data and approval of Prevnar® (PCV7), Prevnar 13® was approved by the FDA using immune response data as a surrogate end point for efficacy1

  • In immunogenicity trials, the 4-dose series of Prevnar 13® demonstrated noninferiority in comparison with PCV7 for 10 of the 13 serotypes. The exceptions were serotypes 6B, 9V, and 3. Although the response to serotypes 6B and 9V did not meet the prespecified noninferiority criterion, the differences were marginal1
  • A serum anticapsular polysaccharide antibody concentration of 0.35 µg/mL, as measured by enzyme-linked immunosorbent assay (ELISA) 1 month after the third dose as a single antibody reference concentration, was used to estimate the effectiveness of Prevnar 13® against invasive pneumococcal disease (IPD) in infants and children1
Surveillance data

CDC surveillance data: Observed disease reduction

US incidence of IPD among children <5 years of age2

Surveillance data

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.3

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 1997 through 2014 reported to the Healthy People 2020 government initiative. Rates were collected through the Active Bacterial Core surveillance (ABCs) system run by the CDC.2

It is not known what percentage of cases was caused by nonvaccine serotypes.2

  • *Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).
  • At 2, 4, 6, and 12 to 15 months of age. In children 6 years through 17 years of age, Prevnar 13® is administered as a single dose.1
  • 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.1