Today, Serotype 19A Is the Leading Cause of IPD in Children
<5 Years of Age1

Since 1998/1999, serotype 19A infections, a serotype not included in PCV7, have more than tripled2

Antibiotic-resistant invasive pneumococcal infections can complicate treatment decisions3

In addition to penicillin, serotype 19A has shown increasing resistance to other antibiotics over time, including erythromycin and cefotaxime, as evaluated between 1998 and 2005.4

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 adults 50 years and older for pneumococcal pneumonia and invasive disease. Indication is based on immune responses
  • 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
  • Effectiveness when administered <5 years after pneumococcal polysaccharide vaccine is not known

IMPORTANT SAFETY INFORMATION

  • 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
  • In adults, antibody responses to Prevnar 13® were diminished when given with inactivated Influenza Virus Vaccine
  • In adults, the commonly reported solicited adverse reactions were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle or joint pain, decreased appetite, chills, or rash
  • 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. Most commonly reported side effects in children 5 years through
    17 years also included hives

Please see full Prescribing Information for Prevnar 13®

References

  1. Centers for Disease Control and Prevention. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine—United States, 2007. MMWR. 2010;59:253-257.
  2. Pilishvili T, Lexau C, Farley MM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201:32-41.
  3. Kyaw MH, Lynfield R, Schaffner W, et al. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med. 2006;354:1455-1463.
  4. Moore MR, Gertz RE Jr, Woodbury RL, et al. Population snapshot of emergent Streptococcus pneumoniae serotype 19A in the United States, 2005. J Infect Dis. 2008;197:1016-1027.
These documents are in PDF (portable document format).
PDF files require Adobe Reader; click here to download this free program.