Pfizer Submits Applications to FDA and EMA for Use of its Pneumococcal Conjugate Vaccine, Prevnar 13®

Pfizer Inc PFE today announced that it has submitted supplemental applications to both the United States Food and Drug Administration and the European Medicines Agency to expand the use of Prevnar 13 to adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine. The FDA is targeting a review cycle of 10 months from the application's submission date, resulting in an expected action date in October 2011, subject to the FDA's acceptance of the application. The EMA will follow the centralized procedure for review of Pfizer's application.