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Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers
Date:5/29/2008

rtunities to accelerate the timing of pediatric filings of the vaccine in the rest of the world from its current target of the first quarter of 2009. Wyeth's investigational 13-valent pneumococcal conjugate vaccine is being studied in Phase 3 global clinical trials in both infants and adults.

Wyeth recently has achieved significant success in bringing new products to market. In the first quarter of 2008 alone, Wyeth obtained three new product approvals in the following therapeutic areas: major depressive disorder, Hemophilia A and opioid-induced constipation.

Pneumococcal Disease

According to the World Health Organization (WHO), pneumococcal disease is the number one vaccine-preventable cause of death in children younger than 5 years of age. Due to the significant burden of pneumococcal disease and demonstrated vaccine efficacy, WHO recommends the priority inclusion of PCV7 in national childhood immunization programs worldwide. WHO notes that once other pneumococcal vaccines offering broader protection become available, countries can assess whether it would be helpful to switch to these vaccines.

Pneumococcal disease affects both children and adults and is a leading cause of illness and death worldwide. Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and describes a group of illnesses, including invasive infections, such as bacteremia/sepsis and meningitis, as well as pneumonia and upper respiratory tract infections, including otitis media.

Important Safety Information about PREVNAR

In clinical trials (n=18,168), 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. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its
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SOURCE Wyeth Pharmaceuticals
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