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. (1.1)
• 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. (1.1)

In 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. (1.2)

In 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. (1.3)

Limitations of Prevnar 13 Use and Effectiveness

• Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine. (1.4)

Children 6 weeks through 5 years: The four-dose immunization series consists of a 0.5 mL intramuscular injection administered at 2, 4, 6, and 12–15 months of age. (2.3)

Children 6 through 17 years of age: a single dose. (2.5)

Adults 18 years and older: a single dose. (2.6)

0.5 mL suspension for intramuscular injection, supplied in a single-dose prefilled syringe. (3)

Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine. (4)

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. (5.3)

• 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 (>5%) 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%). (6.1)
• In children aged 5 through 17 years, the most commonly reported solicited adverse reactions (>5%) were injection site tenderness (>80%), injection site redness (>30%), injection site swelling (>30%), irritability (>20%), decreased appetite (>20%), increased sleep (>20%), fever (>5%), and decreased sleep (>5%). (6.1)
• In adults aged 18 years and older, the most commonly reported solicited adverse reactions (>5%) 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%), vomiting (>5%), fever (>5%), chills (>5%), and rash (>5%). (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

Pediatric Use: Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established. (8.4)