Clinical Data
The impact of Prevnar® on invasive pneumococcal disease (IPD) has been reported in many studies. The CDC surveillance data support continued effectiveness of Prevnar® in reducing the incidence of IPD caused by vaccine serotypes.40
Important
Safety Information
In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever
(
38ºC/100.4ºF), irritability,
drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including Prevnar®. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
Please see Prescribing Information.
Indication
Prevnar® is indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12 to 15 months of age.
The decision to administer Prevnar® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from invasive pneumococcal disease.
Prevnar® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of S. pneumoniae represented in the vaccine, protection against all causes of otitis media is expected to be low.
This vaccine is not intended to be used for treatment of active infection.
