Prevenar 13 regulatory update

Pfizer said the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices said it needs the results of the Phase IV CAPiTA trial of Prevnar 13 before voting on a broad recommendation for the vaccine in adults >=50 years. The double-blind, placebo-controlled trial, which Pfizer expects to complete next year, is evaluating the pneumococcal vaccine in 84,496 adults >=65 years who have not received Pneumovax 23 from Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.).

Last year, FDA granted accelerated approval to Prevnar 13 to prevent pneumococcal disease in adults >=50 years (see BioCentury, Jan. 2). As part of the approval, Pfizer must conduct the postmarketing CAPiTA trial to verify the vaccine's clinical benefit. The trial is evaluating the number of first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP) and vaccine-type invasive pneumococcal disease in each arm. The pharma said it still intends to launch Prevnar 13 for adults >=50 years in the U.S. "in the coming weeks, as planned." ...