New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococc...(<24 months; and 3) a single dose of P...)

Date:6/11/2009

<24 months; and 3) a single dose of Prevenar 13 at age 24 to <72 months. Each of the 3 regimens was shown to elicit immune response levels against all 13 serotypes that were either comparable to or greater than the IgG antibody concentrations achieved in infants after a 3-dose infant series and to have acceptable tolerability and safety profiles.

Overall, the most frequently reported adverse events in the Phase 3 trials included injection site reactions, (redness, swelling, and tenderness), fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea and rash.

Health Economic Models

Three health economic models presented at ESPID estimated the potential public health and economic impact of Prevenar 13. The results of the analyses in the Netherlands, the UK, and Germany and the US suggested that the introduction of Prevenar 13, if approved, to national immunization programs has the potential to further reduce PD levels in children who are vaccinated as well as in the unvaccinated population (through a herd effect). Based on these economic models, the researchers estimated that routine vaccination with Prevenar 13 could be cost effective or cost saving.

Registration Status

To date, Wyeth has submitted regulatory applications for the pediatric use of Prevenar 13 in more than 45 countries. In December 2008, Wyeth submitted a marketing authorization application (MAA) for Prevenar 13 to the European Medicines Agency (EMEA). In March 2009, Wyeth submitted a Biologic License Application (BLA) for Prevenar 13 to the U.S. Food and Drug Administration (FDA). Last month, the FDA granted the BLA priority review -- a designation given to products that, if approved, would be a significant therapeutic or public health advance. Prevenar 13 is also being studied in
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SOURCE Wyeth Pharmaceuticals Copyright©2009 PR Newswire. All rights reserved

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