Pfizer Inc. (NYSE: PFE) issued the following statement in response to today's discussion by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) regarding the use of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults 50 years of age and older.
Pfizer believes Prevnar 13 should be recommended for all adults 50 years of age and older given the current burden of pneumococcal disease in this age group. Along with the ACIP, we are particularly concerned about those adults at heightened risk for pneumococcal disease, especially immunocompromised individuals. However, we also believe that those 65 years of age and older who already have been vaccinated with the pneumococcal polysaccharide vaccine (PPSV) and who have exhausted their options under the existing CDC recommendations are an at risk population.
We are committed to continuing discussions with the CDC about a recommendation concerning the use of Prevnar 13 in adults 50 years of age and older. Pneumococcal disease in adults 50 years of age and older is associated with significant morbidity and mortality. In fact, there are an estimated 25,000 pneumococcal disease-related deaths every year in the United States in that age group. In addition, there are an estimated 440,000 cases of pneumococcal pneumonia in adults 50 years of age and older, accounting for an estimated 200,000 emergency department visits and 300,000 hospitalizations in the United States.
The U.S. Food and Drug Administration (FDA) licensed Prevnar 13 on December 30, 2011, for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. The FDA approved Prevnar 13 under the accelerated approval program, which allows for earlier approval of certain products to help address serious or life-threatening diseases and that have the potential to provide meaningful therapeutic benefit to patients over existing treatments. The approval of this indication was based on immune responses elicited by Prevnar 13, and there have been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive pneumococcal disease.
We are confident that Prevnar 13 has the potential to help address the burden of life-threatening pneumococcal pneumonia and invasive disease in adults 50 years of age and older, while offering a compelling value proposition for the United States health care system. In fact, a cost-effectiveness analysis that was published this week in the Journal of the American Medical Association (JAMA), which was co-authored by the CDC and the University of Pittsburgh School of Medicine, favors vaccinating adults aged 50 and over with Prevnar 13 and indicates that routine use at ages 50 and 65 might reduce the burden of pneumococcal disease in an "economically reasonable fashion." Therefore, we intend to proceed with the launch of Prevnar 13 to health care providers in the United States in the coming weeks, as planned.
Pfizer is currently conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) to fulfill requirements under the accelerated approval program. The Committee indicated today it needs the results of this trial before voting on a broad recommendation for all adults 50 years of age and older. CAPiTA is an efficacy trial involving more than 84,000 subjects 65 years of age and older designed to evaluate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia (CAP) caused by the 13 pneumococcal serotypes contained in the vaccine. Pfizer estimates that this event-driven study will be complete in 2013.
While the rate of uptake for the use of Prevnar 13 by adults 50 years of age and older will be impacted by the outcome of today's ACIP meeting, Pfizer is not changing its 2012 financial guidance.