* Compared to PCV7
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
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
- 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


