INDICATION FOR PREVNAR 13^®

• Prevnar 13^® is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday)
  
  
• Prevnar 13^® is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
  
  
• Prevnar 13^® is also indicated for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A
  
  

IMPORTANT SAFETY INFORMATION FOR PREVNAR 13^®

• Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13^®, Prevnar^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) or any diphtheria toxoid-containing vaccine is a contraindication to the use of Prevnar 13^®
  
  
• Prevnar 13^® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes. Protection against otitis media is expected to be substantially lower than protection against invasive disease
  
  
• Immunocompromised children or children with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to active immunization
  
  
• Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13^®, to infants born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination
  
  
• The most commonly reported serious adverse events were bronchiolitis (0.9%, 1.1%), gastroenteritis (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13^® and Prevnar^®, respectively
  
  
• The most commonly reported solicited adverse reactions (≥20%) in US clinical trials with Prevnar 13^® were redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep
  

Please see full Prescribing Information for PREVNAR 13^®

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