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.

Safety profile

Prevnar 13® showed a comparable adverse event profile to Prevnar®* (PCV7)1
  • A total of 4729 infants and toddlers received at least 1 dose of Prevnar 13® in 13 clinical trials1
  • A total of 1907 subjects received at least 1 dose of Prevnar 13® and 701 subjects received 1 dose of PCV7 in the 3 US studies1
  • A similar proportion of Prevnar 13® and PCV7 recipients reported solicited local and systemic adverse reactions as well as unsolicited adverse events, among US study subjects
  • The most commonly reported adverse reactions (≥20%) in US clinical trials were redness, swelling, and tenderness at the injection site; fever; decreased appetite; irritability; increased sleep; and decreased sleep
  • As shown in clinical trials, Prevnar 13® can be administered concomitantly with routine pediatric vaccines1
  • Responses to diphtheria toxoid; tetanus toxoid; pertussis; polio types 1, 2, and 3; hepatitis B; PRP-T; PRP-OMP; measles; and varicella antigens in Prevnar 13® recipients were similar to those in PCV7 recipients. Based on limited data, responses to mumps and rubella antigens in Prevnar 13® recipients were similar to those in PCV7 recipients
  • In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13® with human papillomavirus (HPV) vaccine; meningococcal conjugate vaccine (MCV4); and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed (Tdap)
  • When Prevnar 13® is administered at the same time as another injectable vaccine(s), the vaccines should always be administered with different syringes and given at different injection sites

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