FDA Okays Pneumococcal Vaccine for Older Adults

From FDA Approvals > Medscape Medical News Megan Brooks January 3, 2012 — The US Food and Drug Administration (FDA) on December 30 approved the pneumococcal 13-valent conjugate vaccine (manufactured by Wyeth Pharmaceuticals, marketed by Pfizer Inc) for adults aged 50 years and older for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. The move comes on the heels of the November 16, 2011, meeting of the FDA's Vaccines and Related Biologics Advisory Committee, in which the committee voted 14 to 1 in favor of expanding the indication for Prevnar 13 to adults. Prevnar 13 was first approved by the FDA in February 2010 for the prevention of invasive pneumococcal disease in infants and young children from age 6 weeks through 5 years. "Substantial" Disease Burden in Adults Pneumococcal infections remain an important cause of morbidity and mortality among older adults, a population that is rapidly expanding. "According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, notes in an agency press release. "Pneumococcal disease is a substantial cause of illness and death. [This] approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group," Dr. Midthun said. Until now, Pneumovax 23 from Merck was the only pneumococcal vaccine licensed in the United States for use in adults aged 50 years and older. In studies conducted among adults 50 and older in the United States and Europe, Prevnar 13 induced antibody levels that were similar to or higher than the levels induced by Pneumovax 23, the FDA notes. Common adverse reactions reported with Prevnar 13 include pain, redness, and swelling at the injection site; limitation of movement of the injected arm; fatigue; headache; chills; decreased appetite; generalized muscle pain; and joint pain. Similar reactions have been observed with Pneumovax 23. The FDA says an additional trial in 85,000 people aged 65 years and older with no history of receiving Pneumovax 23 is underway to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia. The FDA says the expanded indication for Prevnar 13 in adults 50 years and older supports the Department of Health and Human Services' Healthy People 2020 objectives.