Prevnar 13® for
Infants &
Young Children
Invasive pneumococcal disease vaccination for children aged
6 weeks through 5 years.
Prevnar 13® for
Adults
Pneumococcal pneumonia and invasive disease vaccination for adults aged 50
and older.

INDICATIONS FOR PREVNAR 13®

In children 6 weeks through 5 years of age (prior to 6th birthday), Prevnar 13® is a vaccine indicated for:
  • active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F)

  • active immunization for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for other strains included in the vaccine (1, 3, 5, 6A, 7F, and 19A)
Limitations of Use and Effectiveness
  • Prevnar 13® will not protect against disease caused by strains of Streptococcus pneumoniae not contained in the vaccine

IMPORTANT SAFETY INFORMATION

  • Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine
  • Children with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response to Prevnar 13®
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in children include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13® and Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), respectively
  • In infants and toddlers, the most common side effects were irritability, injection site tenderness, decreased appetite, decreased sleep, increased sleep, fever, injection site redness, and injection site swelling
  • Any side effects associated with the vaccination should be reported to your child’s health care provider
  • Ask your health care provider about the risks and benefits of Prevnar 13®. Only a health care provider can decide if Prevnar 13® is right for your child

  Download Full Prescribing Information

INDICATIONS FOR PREVNAR 13®

In adults 50 years of age and older, Prevnar 13® is a vaccine indicated for:
  • active immunization for the prevention of pneumonia and invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based on immune responses elicited by Prevnar 13®. There have
    been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive disease after vaccination with Prevnar 13®
Limitations of Use and Effectiveness
  • Prevnar 13® will not protect against disease caused by strains of Streptococcus pneumoniae not contained in the vaccine
  • The effectiveness of Prevnar 13® when given less than 5 years after the 23-valent pneumococcal polysaccharide vaccine is not known

IMPORTANT SAFETY INFORMATION

  • Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine
  • Adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response to Prevnar 13®
  • In adults, immune responses to Prevnar 13® were reduced when given with injected seasonal flu vaccine
  • In adults aged 50 years and older, the common side effects were pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, injection site redness, injection site swelling, limitation of arm movement, chills or rash
  • Any side effects associated with the vaccination should be reported to your health care provider
  • Ask your health care provider about the risks and benefits of Prevnar 13®. Only a health care provider can decide if Prevnar 13® is right for you

  Download Full Prescribing Information