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Wyeth Provides Regulatory Update on Prevnar 13* in the United States
Date:8/11/2009

ive immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) are the strains that most commonly cause these serious diseases in children. The routine schedule is 2, 4, 6, and 12 to 15 months of age.

Prevnar(R) is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.

As with any vaccine, Prevnar(R) may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.

Important Safety Information for Prevnar((R))

Ask your child's health care provider about the risks and benefits of Prevnar(R) and if Prevnar(R) is right for your child.

In clinical studies, the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar(R). Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar(R) does not protect 100% of children vaccinated. Immunization with Prevnar(R) does not substitute for routine diphtheria immunization.

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