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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 diseaseaused by Streptococcus pneumoniae serotypes 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^®

In children 6 weeks through 5 years of age (prior to the 6th birthday),
Prevnar 13^® is a vaccine 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 Streptococcus 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

Limitations of Use and Effectiveness

• Prevnar 13^® will not protect against disease caused by Streptococcus pneumoniae serotypes that are not in the vaccine
• The effectiveness of Prevnar 13^® administered less than 5 years after 23-valent 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 to the use of Prevnar 13^®
• Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to active immunization due to impaired immune responsiveness
• In adults, antibody responses to Prevnar 13^® were diminished when given with inactivated Influenza Virus Vaccine
• In adults aged 50 years and older the commonly reported solicited adverse reactions were pain at the injection site (>50%), fatigue (>30%), headache (>20%), muscle pain (>20%), joint pain (>10%), decreased appetite (>10%), injection site redness (>10%), injection site swelling (>10%), limitation of arm movement (>10%), chills (>5%) or rash (>5%)
• 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
• In infants and toddlers, 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^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), respectively
• In infants and toddlers vaccinated at 2, 4, 6, and 12-15 months of age in US clinical trials, the most commonly reported solicited adverse reactions were irritability (>70%), injection site tenderness (>50%), decreased appetite (>40%), decreased sleep (>40%), increased sleep (>40%), fever (>20%), injection site redness (>20%), and injection site swelling (>20%)