Expanded label for Prevnar 13

FDA granted accelerated approval to Prevnar 13 from Pfizer Inc. (NYSE:PFE) to prevent pneumococcal disease in adults 50 years and older. FDA approved the product based in part on two Phase III trials that evaluated an immunological surrogate endpoint of immunogenicity compared to Pneumovax 23 from Merck & Co. Inc. (NYSE:MRK). As part of the approval, Pfizer is required to complete a postmarketing trial to verify the clinical benefit. The pharma is conducting a trial in 85,000 patients 65 years and older who have not received Pneumovax 23. ...