Pfizer Provides U.S. Regulatory Update on Prevnar 13 for Use in Adults 50 Years and Older

Pfizer Inc PFE today announced that the U.S. Food and Drug Administration (FDA) has issued a 90-day extension to the action date for the Company's supplemental Biologics License Application (sBLA) for use of Prevnar 13®, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults aged 50 and older. This extends the review period to January 2012. The extension is due to additional data that Pfizer elected to submit from two studies that were part of the original sBLA. These data, which are derived from an additional immune response assay method, were submitted to support the FDA in its evaluation of the concomitant use of Prevnar 13 and trivalent inactivated influenza vaccine (TIV). The FDA considered this data submission to be a major amendment to the filing. Prevnar 13 is under review for active immunization of adults 50 years of age and older for the prevention of pneumococcal disease (including pneumonia and invasive disease) caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine.