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Broader Serotype Coverage Against IPD Compared to PCV71,2

*Compared to PCV7

Examples of IPD include bacteremia and meningitis3


Prevnar 13® effectiveness against IPD was inferred using comparative immunogenicity results from Prevnar®1

  • 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 4 doses, the noninferiority criterion for immunogenicity was met for all serotypes except serotype 31
  • Prevnar 13® elicited functional antibodies for all 13 serotypes following the third and fourth doses1

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 5 years for invasive pneumococcal disease and otitis media (caused by 7 of the 13 serotypes only [4, 6B, 9V, 14, 18C, 19F, and 23F])
  • In adults 50 years of age and older for pneumococcal pneumonia and invasive disease. Indication is based on immune responses

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
  • 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 infants and toddlers, the most commonly reported solicited adverse reactions were injection site tenderness, redness, or swelling, irritability, decreased appetite, decreased or increased sleep, and fever
  • 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

Please see full Prescribing Information for Prevnar 13®

References

  1. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals Inc.
  2. Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals Inc.
  3. 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.
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PREVNAR and PREVNAR 13 are registered trademarks of Wyeth LLC.