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.

• Active immunization for the prevention of otitis media caused by S. 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.

Children 6 Years Through 17 Years of Age (prior to the 18th birthday), Prevnar 13 is Indicated For:

• Active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Adults 18 Years of Age and Older, Prevnar 13 is Indicated For:

• Active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. 

Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.

Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 13.

Individuals with altered immunocompetence, including those at higher risk for invasive pneumococcal disease (e.g., individuals with congenital or acquired splenic dysfunction, HIV infection, malignancy, hematopoietic stem cell transplant, nephrotic syndrome), may have reduced antibody responses to immunization with Prevnar 13.

Available data on Prevnar 13 administered to pregnant women are insufficient to inform vaccine associated risks in pregnancy.

Data are not available to assess the effects of Prevnar 13 on the breastfed infant or on milk production/excretion.

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.

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• Use in patients under 6 weeks of age. GoToSource

Kawasaki disease (inflammation in the walls of medium-sized arteries throughout the body this disease primarily affects children). GoToSource

Dermal necrotizing granulomatous giant cell reaction (area of inflammation in which tissue has died). GoToSource

Pneumonia. GoToSource

Anaphylaxis (life-threatening allergic reaction). GoToSource

Increased risk of febrile seizures when administered with flu vaccine. GoToSource

Claims filed for anaphylactic shock.