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Prevnar 13® is a vaccine approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based upon immune responses to the vaccine.

Young Children

For children 6 weeks through 17 years of age, Prevnar 13®
is approved for the prevention of invasive disease caused
by the 13 vaccine strains, and for children 6 weeks
through 5 years for the prevention of otitis
media caused by 7 of the 13 strains.

INDICATIONS FOR PREVNAR 13®

  • Prevnar 13® is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F)
  • Based upon immune responses to the vaccine, Prevnar 13® is also approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains
  • Prevnar 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine
  • Effectiveness when given less than 5 years after a 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
  • Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever. Most commonly reported side effects in children 5 years through 17 years also included hives
  • In adults, immune responses to Prevnar 13® were reduced when given with injected seasonal flu vaccine
  • In adults, the common side effects were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash
  • 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 or your child

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

 

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PREVNAR 13 is a registered trademark of Wyeth LLC.

PSA625502-01 © 2014 Pfizer Inc. All rights reserved. June 2014

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