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.

Dosing

Recommended dosing schedule

For optimal immune response, complete all 4 doses of Prevnar 13® on time, based on ACIP and AAP recommendations1-3

Recommended dosing schedule
  • In infants and young children, Prevnar 13® is administered as a 4-dose series at 2, 4, 6, and 12 to 15 months of age1*†‡

Scheduling the fourth dose for 12 months allows for unforeseen delays, and therefore may help with timely completion of the full series

  • In children 6 years through 17 years of age, Prevnar 13® is administered as a single dose1
  • Prevnar 13® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes1
  • Additional dosing information 

    For children 7 months through 5 years of age who have not received Prevnar 13®, one of the following three catch-up schedules should be used based on the child’s age when administered the first dose.1

    • Children 7 through 11 months of age should receive 2 doses administered at least 4 weeks apart and a third dose after the 1-year birthday, separated from the second dose by at least 2 months
    • Children 12 through 23 months of age should receive 2 doses at least 2 months apart
    • Children 24 months through 5 years of age (prior to the sixth birthday) should receive a single dose

    The immune responses induced by a catch-up schedule may result in lower antibody concentrations for some serotypes compared with antibody concentrations following 4 doses of Prevnar 13® given at 2, 4, 6, and 12 to 15 months of age.1

  • *The first dose may be given as early as 6 weeks of age.1
  • The recommended dosing interval for the first, second, and third doses is 4 to 8 weeks.1
  • The fourth dose should be administered at approximately 12 to 15 months of age and at least 2 months after the third dose.1
  • §Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).

AAP=American Academy of Pediatrics; ACIP=Advisory Committee on Immunization Practices.

Antibody concentrations

Antibody concentrations wane considerably from 7 to 12 months of age, prior to the fourth dose of Prevnar 13®4

Antibody concentrations for infants
Antibody concentrations for infants
  • Study description 

    Phase 3, double-blind, active-controlled, multicenter trial involving 666 infants randomized to receive 4 doses of Prevnar 13® (n=334) or Prevnar®§ (PCV7) (n=332) given at 2, 4, 6, and 12 to 15 months of age. A total of 294 infants in the Prevnar 13® group completed the first 3 doses, of which 252 were evaluable for immunogenicity. A total of 264 toddlers received the fourth dose of Prevnar 13®, of which 239 were evaluable for immunogenicity. Pneumococcal antipolysaccharide IgG GMCs were calculated from blood samples taken 1 month after the third dose, before the fourth dose, and 1 month after the fourth dose. The mean age at the fourth dose in this study was 12.4 months.4

  • Prevnar 13® immunogenicity 

    Prevnar 13® effectiveness against IPD was inferred using comparative immunogenicity results from PCV7.

    • When measured 1 month following the third dose, the noninferiority criterion for immunogenicity was met for all serotypes except 6B, 9V, and 3. The differences for serotypes 6B and 9V were marginal. One month after the fourth dose, the noninferiority criterion for immunogenicity was met for all serotypes except serotype 3
    • Prevnar 13® elicited functional antibody responses for all 13 serotypes following the third and fourth doses
Delayed dosing

Delayed doses may lead to incomplete immunization, which means that children may not be fully vaccinated during a time of greater risk5,6

Consequences of delayed dosing for infants
In a cohort analysis, there was a 69% reduction in well visits during the second year of life compared with the first year of life or total well visits in year 2 vs year 15
Consequences of delayed dosing for infants
Of children in the same cohort analysis who did not receive the fourth dose of Prevnar 13® at 12 to 15 months of age, 58% did not receive the fourth dose by 24 months5

Delayed doses may lead to incomplete vaccination. Therefore, it’s crucial to stress the importance of receiving the full 4-dose series on time to all of your patients5

QuintilesIMS, Real World Data, Cohort Selection 01/201203/2012, 01/201303/2013, and 01/201403/2014.
The data file utilizes 24-month tracking (that is, a cohort consists of children who had a well visit at 0 months old between 01/201203/2012, 01/201303/2013, and 01/201303/2014. These children were then tracked individually over a 24-month period).5

  • Study description 

    Analysis includes 222,441 children who did not receive a fourth dose of Prevnar 13® at 12 to 15 months of age. Missed opportunities were defined as well visits during which the patient had the potential to receive a dose of Prevnar 13® but did not receive one. Information about reasons for missing well visits was not collected.5