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 adults 50 years and older for pneumococcal pneumonia and invasive disease. Indication is
based on immune responses - 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])
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 - 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 - 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
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