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Wyeth's Prevenar 13* Receives First Approval
Date:7/14/2009

routine immunization schedule for Prevenar 13 Valent in Chile is at ages 2, 4, 6, and 12 to 15 months, and the vaccine can be administered at the same time as other regularly administered childhood vaccines. Children who have already initiated a vaccination program with Prevenar* can transition to Prevenar 13* Valent at any point in their dosing schedule to help protect them from the six additional disease serotypes included in Prevenar 13 Valent. Children aged 7 months through 5 years should follow the appropriate dosing schedule for their age group. There is no information about the interchangeability of Prevenar or Prevenar 13 Valent with any other pneumococcal conjugate vaccine that does not contain protein carrier CRM(197). Wyeth expects Prevenar 13 Valent will be commercially introduced in Chile later this year.

The Company initiated its global pediatric filings in late 2008 and, to date, has submitted regulatory applications for Prevenar 13 in more than 50 countries spanning six continents and has been granted priority review in the U.S., Canada, Australia and South Africa. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

About Pneumococcal Disease

Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media.

Important Safety Information for Prevenar 13*

In clinical studies, the most commonly reported adverse events in children were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Risks are associated with all vaccines, including Prevenar 13.
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SOURCE Wyeth Pharmaceuticals
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